Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Equipped With the "Closed-loop" Automated Insulin Delivery System (or "Artificial Pancreas"), Under Normal Conditions of Use
Phase: NA
Conditions: Diabetes type1
Sponsor: Air Liquide Santé International

 
AIR LIQUIDE SANTE INTERNATIONAL 
 
SATURN - ALMED-19-001 
 
 
 
 
SATURN – ALMED-19-001 
 
Study Protocol  
 
 
Title 
Evaluation of satisfaction regarding home healthcare provider (PSAD) management of type 1 diabetic 
patients equipped with the "closed-loop" automated insulin delivery system (or "artificial pancreas"), 
under normal conditions of use. 
 
NCT number 
NCT04635280 
 
Date of the Study Protocol for CTGov recording 
04 October 2024 
From : Final version Protocol No. 3.0 of 01/19/2021 - English version of 05/06/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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PROTOCOL 
Reference number: ALMED-19-001 
Acronym: SATURN 
Title:  
Evaluation of satisfaction regarding home healthcare provider (PSAD) management of type 1 diabetic 
patients equipped with the "closed-loop" automated insulin delivery system (or "artificial pancreas"), 
under normal conditions of use. 
RCB-ID number: 2019-A02469-48 
 
 
Coordinating Investigator 
Name 
Contact Information 
Prof. Hélène Hanaire 
Hôpital de Rangueil 
Service de Diabétologie - Maladies métaboliques - Nutrition 
1 Avenue du Professeur Jean Poulhès - TSA 50032 
31059 Toulouse Cedex 9 
France 
Tel.: +33 (0)5 61 32 30 18 - Fax: +33 (0)5 61 32 31 23 
 
Sponsor 
Name 
Contact Information 
AIR LIQUIDE SANTE INTERNATIONAL 
Air Liquide Santé International 
75 Quai d’Orsay 
75007 Paris 
France 
Tel.: +33 (0)1 39 07 69 39 - Fax: +33 (0)1 39 07 61 99 
Confidential Information 
The information contained in this Protocol is confidential and is intended for use by clinical investigators only. 
It is the property of Air Liquide Santé International or its subsidiaries and may not be copied or distributed to persons not involved in this 
clinical study, unless such persons are bound by a confidential agreement with Air Liquide Santé International or its subsidiaries. 

 
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SIGNATURE PAGE 
SPONSOR 
 
 
Title of the study: Evaluation of satisfaction regarding home healthcare provider (PSAD) management of type 
1 diabetic patients equipped with the "closed-loop" automated insulin delivery system (or "artificial 
pancreas"), under normal conditions of use. 
 
Final version Protocol No. 3.0 of 01/19/2021 - English version of 04/19/2021 
 
Name  
Contact Information 
Medical manager: Dr Juan-Fernando Ramirez, 
Medical Vice President 
Tel.: +33 (0)1 39 07 63 42 
Fax: +33 (0)1 39 07 61 99 
juan-fernando.ramirez@airliquide.com  
 
Air Liquide Santé International 
Campus Innovation Paris 
1 Chemin de la Porte des Loges 
BP126, Les Loges en Josas 
78354 Jouy-en-Josas 
France 
 
Date 
Signature 
___/___/______ 
 
Contact: Marie-Danielle Milcent-Lamielle, 
Project Manager 
Tel.: +33 (0)1 39 07 69 39 
Fax: +33 (0)1 39 07 61 99 
marie-danielle.milcent-lamielle@airliquide.com 
 
 
 

 
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SIGNATURE PAGE 
COORDINATING INVESTIGATOR 
 
 
Title of the study: Evaluation of satisfaction regarding home healthcare provider (PSAD) management of type 
1 diabetic patients equipped with the "closed-loop" automated insulin delivery system (or "artificial 
pancreas"), under normal conditions of use. 
 
Final Version Protocol 3.0 of 19/01/2021 
 
Name 
Contact Information 
Prof. Hélène Hanaire 
Tel.: +33 (0)5 61 32 30 18 
Fax: +33 (0)5 61 32 31 23 
Hôpital de Rangueil 
Service de Diabétologie - Maladies métaboliques - Nutrition 
1 Avenue du Professeur Jean Poulhès - TSA 50032 
31059 Toulouse Cedex 9 
France 
 
 
Date 
Signature 
___/___/______ 
 
 
 

 
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SIGNATURE PAGE 
INVESTIGATOR'S OBLIGATION 
 
 
Title of the study: Evaluation of satisfaction regarding home healthcare provider (PSAD) management of type 
1 diabetic patients equipped with the "closed-loop" delivery system (or "artificial pancreas"), under normal 
conditions of use. 
 
 
 
By signing below, I confirm that I agree: 
- To conduct the study in accordance with the Protocol, the Clinical Best Practices (CBP), the study's specific 
procedures and the regulations in effect. 
- To train the personnel involved in the study and document any delegation of tasks within the framework 
of this study. In the event of personnel changes during the course of the study, I undertake to inform the 
sponsor. 
- To comply with the recommendations set forth in the user manuals for the "closed-loop" automated 
insulin delivery systems (or "artificial pancreas"). 
- To adhere to the procedures and regulations related to data recording, including serious adverse events. 
- To authorise direct access to source data for monitoring purposes as well as for audit or inspection. 
- To retain the essential documents relating to the study for a period of 15 years from the date of the last 
publication. 
- Not to present or publish the study data without the prior authorisation of the sponsor. 
In addition, I hereby confirm that I have and will have the human and material resources needed to conduct 
this study. 
 
Name and Title 
Contact Information 
 
 
Date 
Signature 
___/___/______ 
 
 
 

 
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CONTACT 
Coordinating Investigator: 
Prof. Hélène Hanaire 
Hôpital de Rangueil 
Service de Diabétologie - Maladies 
métaboliques - Nutrition 
1 Avenue du Professeur Jean Poulhès - TSA 
50032 
31059 Toulouse Cedex 9 
Sponsor: 
Air Liquide Santé International 
75 Quai d’Orsay 
75007 Paris - France 
 
Data Protection Officer: 
Air Liquide  
Délégué à la Protection des Données 
75, Quai d'Orsay 
75007 Paris - France 
https://www.airliquide.com/fr/groupe/contactez-
nous-rgpd 
 
Research and Development Centre: 
Campus Innovation Paris 
Medical R&D 
1 Chemin de la Porte des Loges 
BP 126 
78 354 Jouy-en-Josas Cedex - France 
 
 Medical Vice President 
Juan-Fernando Ramirez, MD, PhD 
Tel.: + 33 1 39 07 63 42 / +33 6 35 51 11 25 
 Director of Real World & Clinical Evidence  
Cécile Delval, MD 
Tel.: +33 1 39 07 65 18 / +33 6 03 62 17 95 
 Study physician 
Guila Lancman, MD  
Tel.:  +33 6 47 19 95 78 
 Head of Biometrics 
Gisèle Al-Hamoud 
Tel.: + 33 1 39 07 20 69 / +33 6 12 72 16 38 
 Project Manager 
Marie-Danielle Milcent-Lamielle 
Tel.: + 33 1 39 07 62 75 / +33 6 19 94 71 13 
 Biostatistician 
Manuella Schaller 
Tel.: + 33 1 39 07 60 79 / +33 6 71 03 44 48 
 
 
 
 
 
 

 
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SYNOPSIS 
 
Title Evaluation of satisfaction regarding home healthcare provider (PSAD) 
management of type 1 diabetic patients equipped with the "closed-
loop" automated insulin delivery system (or "artificial pancreas"), 
under normal conditions of use. 
Acronym 
SATURN 
Protocol number 
ALMED-19-001 
Sponsor 
AIR LIQUIDE SANTE INTERNATIONAL 
Clinical Research Organisation  
(CRO) 
ICTA PM 
11 Rue du Bocage 
21121 Fontaine Lès Dijon 
France 
Tel.: +33 (0)380 534 000 – Fax: +33 (0)380 571 022 
Coordinating Investigator 
Prof. Hélène Hanaire 
Hôpital de Rangueil 
Service de Diabétologie - Maladies métaboliques - Nutrition 
1 Avenue du Professeur Jean Poulhès - TSA 50032 
31059 Toulouse Cedex 9 
Centres 
2 hospital centres in France 
List of investigators: 
- Prof. Hélène Hanaire, Toulouse University Hospital Hôpital Rangueil, 
Toulouse 
- Dr Lucy Chaillous, Hôpital Nord, Nantes 
Number of patients 
35 patients included, in order to have 32 evaluable patients 
Study context and rationale/  
Medical Device  
Type 1 diabetes is an auto-immune disease characterised by chronic 
hyperglycaemia (blood glucose levels are too high), caused by the 
destruction of pancreatic beta cells of islets of Langerhans, which 
therefore no longer produce insulin. The absence of insulin prevents 
the body from storing and using glucose, exposing the individual to a 
major risk of hyperglycaemia.  
The treatment of type 1 diabetes is based on insulin therapy. For 
patients, excessive injection of insulin causes an increased risk of 
hypoglycaemia, especially between meals.  
Insulin deficiency can lead to diabetes ketoacidosis or even coma.  
The treatment of type 1 diabetes is based on the administration of 
insulin multiple times a day to compensate for the body's lack of 
insulin production. Glucose levels must first be measured, and the 
doses to be administered must be calculated and adapted to the 
patient's activities, particularly meals and sporting activities. 
Glycaemic control is the primary objective in the management of 

 
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patients with type 1 diabetes. The continuous adjustment of insulin 
doses aims to get as close as possible to normoglycaemia, to avoid 
hyper and hypoglycaemic surges on a daily basis, and to prevent 
chronic and degenerative micro and macrovascular complications 
over the long term, which are the major cause of morbidity and 
mortality for this pathology. 
The advent of innovative medical devices such as continuous glucose 
monitoring systems, which take regular measurements without 
patients having to prick their fingers, insulin pumps which allow 
insulin to be continuously delivered via a catheter, and algorithms for 
calculating the insulin dose, have expedited the development of 
"closed-loop" automated insulin delivery systems, or the "artificial 
pancreas". These systems are able to automatically adjust the insulin 
dose to be injected. The patient continues to record meals eaten and 
sequences of physical activity, but it is the algorithm that continuously 
determines the insulin flow rate adjustments. 
Teaching patients how to use these medical devices is essential and 
indispensable for their proper functioning, and includes proficiency in 
the system’s three components (pump, sensor and control 
module/terminal), understanding the messages of the control 
module/terminal, and the ability to respond to system failures and 
switch to manual mode. In addition, providing support to diabetic 
patients throughout their treatment ensures the proper use of 
medical devices and guarantees their effectiveness in both the short 
and long term. 
This study will be used to assess the support given by home 
healthcare providers (PSADs) to type 1 diabetic patients using a 
"closed-loop" automated insulin delivery system (or "artificial 
pancreas"), and specifically the satisfaction of the various people 
involved (patients, PSADs, hospital healthcare teams) and their 
interactions. 
Among the “closed-loop” automated insulin delivery systems (or 
“artificial pancreas”) that have obtained CE marking, the study will 
focus on:  
- 
The DBLG1TM System developed by Diabeloop, which 
includes a Kaleido® insulin pump with a Dexcom G6® 
continuous glucose monitoring (CGM) sensor, combined 
with a dedicated terminal containing the Loop Mode 
algorithm.  
- 
The t:slim X2 pump, featuring Control-IQ™ technology from 
Tandem Diabetes Care, Inc., combined with a  Dexcom G6® 
continuous glucose monitoring sensor and a data 
visualisation system for CGM values and insulin flow rates via 
the diasend® tool. 
Population concerned 
Adult type 1 diabetic patients for whom the investigator proposes the 
use of a "closed-loop" automated insulin delivery system (or 
"artificial pancreas"). 

 
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Methodology 
National, multi-centre, longitudinal, non-comparative interventional 
study with minimal risks and constraints (RIPH2). 
Objectives Primary objective: 
To assess satisfaction and experience regarding home healthcare 
provider (PSAD) management after 1 and 3 months of follow-up (D30 
and D90) of type 1 diabetic patients equipped with a "closed-loop" 
automated insulin delivery system (or "artificial pancreas"), under 
normal conditions of use. 
Secondary objectives: 
Home healthcare provider (PSAD) management: 
o To describe home healthcare provider management (number, 
type, time and reasons for interaction), according to the various 
phases of installing a "closed-loop" automated insulin delivery 
system (pre-installation, installation, post-installation). 
o To compare the management observed with the theoretical 
management set out in the opinion of the HAS (French National 
Authority for Health) dated 28 January 2020 for the Diabeloop 
DBLG1TM system using the reimbursement record for the 
DBLG1TM "closed-loop" automated insulin delivery system (or 
"artificial pancreas"). This reference document will be 
extrapolated/applied to all the "closed-loop" systems used in the 
study.  
o To assess the knowledge acquired by the patient during their 
technical training, on D1/D3, D30 and D90. 
o To describe the satisfaction of the PSAD nurses at the end of the 
study. 
Patient questionnaire: 
o To describe the patient's profile in terms of their experience with 
medical devices, at the time of inclusion, and their feelings about 
their current and future state of health, at inclusion and on D90, 
in order to contextualise the level of patient satisfaction. 
o To describe the quality of life of patients and the daily constraints 
faced by the patient, at inclusion, on D30 and on D90, in order to 
measure the effects of management with a "closed-loop" 
automated insulin delivery system (or "artificial pancreas") and 
PSAD services on the patient's quality of life. 
o To describe the relation to the "closed-loop" automated insulin 
delivery system (or "artificial pancreas"), the benefits expected 
at inclusion and those perceived on D30 and D90, in order to 
measure the impact of the management on the patient's 
autonomy and the reduction of their mental load. 
Investigator questionnaire: 
o To describe the satisfaction, assessed at the end of the study, of 
hospital healthcare teams with patient management by PSADs in 

 
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the pre-installation/installation and 3-month follow-up phases, 
under the conditions of use of a "closed-loop" automated insulin 
delivery system (or "artificial pancreas"). 
o To describe, at the end of the study, the interactions between 
hospital healthcare teams and PSADs in terms of frequency and 
satisfaction. 
o To describe, at the end of the study, the benefit of the data 
visualisation platform for investigators, in order to improve 
patient follow-up. 
Safety: 
o To describe the safety profile of patients after 3 months of 
follow-up with the "closed-loop" automated insulin delivery 
system (or "artificial pancreas"). 
Clinical course: 
o To describe the patient's clinical profile (metabolic balance) and 
its evolution, at inclusion, and on D30 and D90, in order to 
contextualise the study results. 
 
Exploratory objectives: 
Economic assessment of the service, in volume and costs 
o To describe the economic indicators of the service: 
o Cost of training acquired on D1/D3, D30 and D90 
 
Cost of acquiring the training according to 
socio-professional data 
o Average cost of the service for patients without technical 
incidents  
o Average cost of the service for patients in the event of a 
technical incident  
o Average total cost of the service for each phase (pre-
installation, installation, follow-up): 
 
Relative proportion of the cost of failure 
management in the average cost of the 
service 
 
Relative proportion of the cost of additional 
training in the average cost of the service 
o Consumption of consumables and associated costs 
o Cost of the "closed-loop" automated insulin delivery 
system (or "artificial pancreas") 
o To describe the quality indicators of the service: 
o Percentage of patients with training validated on D1/D3, 
D30 and D90  
o Number of calls/patient broken down by call type 
(technical, medical, etc.): 
 
With training validated on D1/D3, D30, D90 
 
Without training validated on D1/D3, D30, 
D90 

 
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o Medical prescription decision-making aid: percentage of 
patients not eligible for the "closed-loop" automated 
insulin delivery system (or "artificial pancreas") 
following a pre-installation visit (assessment of the 
patient's motivation and ability to use such a system) 
o Percentage of visits following a technical incident call 
o Time and frequency that the patient’s data is viewed on 
the platform for the "closed-loop" system to detect any 
technical problems. 
Sub-group assessment 
To describe and compare PSAD management and the satisfaction of 
the various people involved (patient, investigator, PSAD) between 
patients who have already used a "closed-loop" automated insulin 
delivery system (or "artificial pancreas"), versus patients who were 
device-naive prior to inclusion in the study. 
Questionnaires Patient questionnaires: 
The following validated questionnaires will be used: 
o CSQ-8 Questionnaire: Measures patients' overall satisfaction 
with their management in general.  
o EQ-5D-5L Questionnaire: Measures the patient's quality of life in 
the context of using a "closed-loop" automated insulin delivery 
system (or "artificial pancreas"), in terms of the impact on their 
activities (mobility, self-care, usual activities, , pain/discomfort, 
anxiety/depression).  
o HFS-II (Hypoglycaemia Fear Survey-II) questionnaire: Measures 
quality of life and daily constraints with respect to 
hypoglycaemia-related behaviours and concerns in adults with 
type 1 diabetes. 
o BMQ (Beliefs about Medicines Questionnaire) Questionnaire: 
The specific section of this questionnaire will be used. It 
describes the patient's perception of the Medical Device (MD) in 
a wider sense.  
The following ad-hoc questionnaires, developed by the French 
Federation of Diabetics (FFD), will be used: 
o Questionnaire entitled "You and medical devices": This is used 
to determine the patient's profile with regard to their experience 
with medical devices.  
o Questionnaire entitled: "You and your health": This assesses the 
patient's feelings about their current and future state of health.  
o Questionnaire entitled: "You and your daily constraints": This 
assesses the daily constraints encountered by the patient in the 
past month based on a pre-established multiple-choice list.  
o Questionnaire entitled "You and the "closed-loop" automated 
insulin delivery system (or "artificial pancreas")": This assesses 

 
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the expected and perceived benefits of the "closed-loop" 
automated insulin delivery system (or "artificial pancreas").  
o Questionnaire entitled "You and your management by your 
home healthcare provider": This measures patients' targeted 
experience / satisfaction with their management by the PSADs 
during the follow-up period. 
Investigator satisfaction questionnaire:  
This is a five-part ad-hoc questionnaire developed by the sponsor: 
o General questions about the study and the "closed-loop" 
automated insulin delivery system (or "artificial pancreas") 
o Assessment of the follow-up conducted by the PSAD nurse 
during the initial period, i.e. before the patient returns home 
o Assessment of the follow-up conducted by the PSAD nurse 
after the patient returns home 
o Overall satisfaction 
o Access to data and use of the data visualisation platform. 
 
PSAD satisfaction questionnaire:  
The satisfaction of PSAD nurses is assessed using an ad-hoc 
questionnaire developed by the sponsor, which relates to the training 
received on the "closed-loop" automated insulin delivery system (or 
"artificial pancreas"), logistical aspects associated with the 
equipment, the quality of the products, use of the medical device, the 
relevance of the follow-up Protocol offered to the patient and 
relationships with the hospital service. 
 
Evaluation criteria 
Primary criterion: 
Patient satisfaction and experience are assessed by 2 questionnaires, 
on D30 and D90: the CSQ-8 questionnaire and the "You and your 
management by your home healthcare provider" questionnaire. 
With the CSQ-8, the patients' overall satisfaction with their 
management in general is determined by a score above 20 points (on 
a scale from 8 to 32) on D30. Maintenance of satisfaction is measured 
on D90 by a score above 20 points which has not decreased by more 
than 4 points compared with D30. 
The safety profile with the questionnaire "You and your 
management by your home healthcare provider". The answers to all 
questions with 5 possible choices and the scores based on the scales 
from 1 to 10 will be described.  
Secondary criteria: 
Home healthcare provider (PSAD) management: 
o PSAD management is described during the different phases (pre-
installation, installation, follow-up), by the number of 
interactions, their type (visits / telephone calls), the time spent, 
the reason for these interactions and, for the visits, by their 
location (home / hospital).  

 
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o The management observed is also described for all the “closed-
loop” systems used in the study according to whether or not 
these interactions were set out in the opinion of the HAS (French 
National Authority for Health) dated 28 January 2020 for the 
Diabeloop DBLG1TM system, and is therefore compared with the 
management initially scheduled for conducting the study 
(number of visits or telephone calls made versus those 
scheduled).  
o The knowledge acquired by the patient during their initial 
training is evaluated by the PSAD nurse using the acquired 
knowledge assessment questionnaire on D1/D3, D30 and D90.  
o The satisfaction of the PSAD nurses is assessed with the PSAD 
satisfaction questionnaire. This questionnaire is completed 
once by each PSAD nurse at the end of the study (after the D90 
of the last patient at the centre). It takes into account the PSAD 
nurse's opinion on all of the services they provide. 
 
Patient questionnaires: 
o The patient's profile in terms of their experience with medical 
devices is assessed by the "You and medical devices" 
questionnaire completed at the time of inclusion. 
o The patient's feelings about their current and future state of 
health are assessed by the "You and your health" questionnaire 
completed at inclusion and on D90. 
o The patient's quality of life is assessed by the EQ-5D-5L 
questionnaire, at inclusion, on D30 and D90. The daily 
constraints encountered by the patient are assessed based on 
the past month, with the question "You and your daily 
constraints", at inclusion, on D30 and on D90. 
o Quality of life and daily constraints related to the risk of 
hypoglycaemic episodes are assessed by the HFS-II questionnaire 
at inclusion, on D30 and D90. 
o The expected and perceived benefits with respect to the "closed-
loop" automated insulin delivery system (or "artificial pancreas") 
are assessed by the questionnaire "You and the "closed-loop" 
automated insulin delivery system (or "artificial pancreas")", 
completed at inclusion, on D30 and D90. 
o The patient's beliefs related to the medical treatment are 
assessed by the specific section of the BMQ (Beliefs about 
Medicines Questionnaire) questionnaire, at inclusion, on D30 
and D90. 
Investigator satisfaction questionnaire:  
This questionnaire is completed once by each investigator at the 
end of the study (after the last patient has left the centre). It takes 
into account the investigator's opinion on all of their included 
patients. 

 
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Safety: 
The safety profile of patients with a "closed-loop" automated insulin 
delivery system (or "artificial pancreas") is described according to: 
o All serious adverse events (SAEs) and non-serious adverse 
events, both related and unrelated to the "closed-loop" 
automated insulin delivery system (or "artificial pancreas"), 
whether expected or unexpected. 
o Episodes of severe hypoglycaemia requiring the intervention of 
a third party for glucose administration. 
o Episodes of hyperglycaemia with ketosis. 
o All incidents related to the "closed-loop" automated insulin 
delivery system (or "artificial pancreas"). 
 
Clinical course: 
The patient's clinical profile and its evolution are described by the 
values of: 
o HbA1c, measured at the time of installation and on D90. 
o Daily average blood sugar level and its variability (standard 
deviation and coefficient of variation, if applicable) at inclusion, 
on D30 and D90. 
o Percentage of time spent over a 4-week period: in the blood 
sugar target [70-180 mg/dl], in hypoglycaemia (< 70 mg/dl) and 
in hyperglycaemia (> 180 mg/dl) at inclusion, on D30 and D90.  
o Percentage of time spent using a closed-loop system over a 4-
week period, if available, on D30 and D90. 
 
Exploratory criteria: 
Economic assessment of the service, in volume and costs: 
o Description of the economic indicators of the service:  
o Generally speaking, the costs will not be collected 
directly, but will be calculated based on the number of 
visits and/or calls made by the PSAD to deliver the 
service in the various scenarios mentioned (see 
secondary criteria "PSAD management"). The flat rate 
per intervention type (visit or telephone) in the pricing 
grid provided by the PSAD will be used to estimate the 
costs. The total cost includes the cost of the PSAD in the 
hospital, at the patient's home and remotely.  
o The PSAD communicates the cost of the “closed-loop” 
automated insulin delivery system (or “artificial 
pancreas”). 
o The consumption of consumables (such as pump 
consumables, glucose sensors, etc.) is described on the 
basis of interactions with the PSAD and the amount of 

 
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consumables actually used by the patient. Consumption 
is compared with a theoretical consumption based on 
the service life of the consumables for the study period. 
 
o Description of the service quality indicators: each quality 
indicator for the service delivered by the PSADs will be 
described: 
o Percentage of patients with training validated on D1/D3, 
D30 and D90 
o Percentage of patients with training validated on D1/D3, 
D30 and D90 according to socio-professional data 
o Number of calls/patient broken down by call type 
(technical, medical, etc.): 
 
With training validated on D1/D3, D30, D90 
 
Without training validated on D1/D3, D30, 
D90 
o Medical prescription decision-making aid: percentage of 
patients not eligible for the "closed-loop" automated 
insulin delivery system (or "artificial pancreas") 
following a pre-installation visit (assessment of the 
patient's motivation and ability to use such a system)  
o Percentage of visits following a technical incident call  
o Time and frequency that the patient’s data is viewed on 
the platform for the "closed-loop" system to detect any 
technical problems. 
Sub-group assessment 
The results will be described for all patients and for the sub-group of 
patients who have already used a "closed-loop" automated insulin 
delivery system (or "artificial pancreas"), including an earlier version 
used in previous clinical trials, versus patients who were device-naive 
prior to inclusion in the study. 
Selection of the patients Inclusion criteria: 
1. Type 1 diabetic patient diagnosed for at least 2 years 
2. Patient treated with an external insulin pump for at least 6 
months 
3. Patient with an HbA1c level less than or equal to 10% in the 
past 4 months (assay performed in a medical analysis 
laboratory or equivalent) 
4. Patient with U-100 rapid-acting insulin (Novorapid or 
Humalog) requirements between the upper and lower 
bounds set by the pump of the "closed-loop" automated 
insulin delivery system (or "artificial pancreas") 
5. Patient who is not isolated, who does not live alone or who 
has a "resource" person living nearby with his/her own 
telephone and a key to the patient’s house 
6. Patient living in an area covered by a GSM (Global System for 
Mobile Communications) network and not planning to travel 
outside France or outside an area covered by a GSM network 

 
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within 30 days of the "closed-loop" automated insulin 
delivery system (or "artificial pancreas") being installed 
7. Patient at least 18 years old and whose age complies with 
the eligibility criteria for each medical device of the "closed-
loop" automated insulin delivery system (or "artificial 
pancreas") 
8. Patient registered with a Social Security scheme 
9. Patient who has agreed to comply with the requirements of 
the study and has signed the free and informed consent form 
10. Patient who the investigator deems capable of using a 
"closed-loop" automated insulin delivery system (or 
"artificial pancreas") under normal conditions of use 
Exclusion criteria: 
1. Patient with any serious pathology that could affect their 
participation in the study  
2. Patient undergoing treatment that could affect the 
physiology of diabetes, i.e., that leads to interactions with 
glucose and/or insulin, in the investigator's judgement  
3. Patient benefiting from a legal protection measure 
4. Pregnant or breastfeeding women 
5. Absence of contraception deemed effective by the 
investigator for a woman of childbearing age 
6. Psychological and/or physical state which could affect the 
proper monitoring of the study procedures 
7. Severe hypoglycaemia which has led to convulsions or a loss 
of consciousness in the last 12 months 
8. Decrease in the perceived sensation of hypoglycaemia, in the 
investigator's judgement 
9. Impaired renal function (creatinine clearance < 30 ml/min 
measured in the last 6 months) 
10. Patient who has had a pancreas or pancreatic islet transplant 
11. Patient with serious uncorrected hearing and/or visual 
problems 
12. Patient included in another clinical study or who has taken 
part in another clinical study in the last 30 days 
Conduct of the study Patients will be monitored for a period of 3 months, starting from the 
end of the device installation procedure. 
The management proposal consists of three distinct phases: pre-
installation, installation and follow-up. During these three phases, the 
number and duration of interactions (visits/telephone calls) may vary 
according to the patient's needs, the investigator's judgement and 
practice, and the judgement of PSAD staff.  
Two French hospitals and their PSAD representatives, whose contact 
details are provided on the investigator list, will participate in the 
study. 
Pre-installation phase: 
The pre-installation phase will be conducted in two stages: 

 
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- 
The patient inclusion visit in the hospital centre, when the 
patient will give their free and informed consent, and the 
investigator will submit the request for management and 
initiation by the PSAD. 
- 
Pre-installation visit(s) by a PSAD nurse at the investigator's 
request. 
This 
period 
corresponds 
to 
the 
patient's 
management by the PSAD via one or two home visits to 
introduce the patient to the system, and assess their 
motivation and their ability to use the medical device. 
Installation phase: 
The "closed-loop" automated insulin delivery system (or "artificial 
pancreas") will be installed during a scheduled hospital stay (or 
outpatient visits) in the hospital centre for a variable duration, 
estimated between 2 and 3 days.  
At the prescriber's request, the sensor can be installed prior to 
installing the complete "closed-loop" automated insulin delivery 
system (or "artificial pancreas"), and this can be done either in 
hospital by hospital staff or at the patient's home during a pre-
installation visit by the PSAD nurse. 
The estimated number of visits carried out by the PSAD is between 1 
and 3 during the installation phase, including at least one visit to the 
hospital centre. 
The pre-installation and installation phases include at least 2 patient 
visits to the hospital centre, and 2 to 5 visits by the PSAD (at home 
and in the hospital centre). The PSAD's role is to provide the patient 
with initial technical training. This training will be assessed by the 
PSAD (questionnaire) and will be followed by written feedback to the 
investigator (prescriber). 
The end of the patient's hospitalisation and their return home, i.e. the 
end of the installation phase, shall be considered to be D0 for patient 
follow-up. 
Follow-up phase (post-installation): 
- Post-installation early follow-up between D1/D3: 
This follow-up will be carried out by the PSAD nurse via a home 
visit or telephone call. It will be used to check that the patient has 
mastered how to use their device (thorough understanding and 
correct use of the "closed-loop" automated insulin delivery 
system (or "artificial pancreas")). 
- Home visit for the first sensor change by the PSAD nurse: 
The PSAD nurse will conduct this follow-up to provide refresher 
training on best practices for the use of the pump and sensor and 
to assist with changing the first glucose sensor. 
- Follow-up one month after installation (D30): 

 
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This follow-up will be carried out by the PSAD nurse via a home 
visit or telephone call. It is recommended to provide refresher 
training and assess the patient's acquired knowledge. 
The investigator will also conduct a patient follow-up on D30 by 
visiting the patient in the hospital or consulting by telephone. 
They will collect the metabolic balance over a 4-week period and 
assess the patient's continued use of the system via the data 
visualisation platform. 
- Follow-up at 3 months: 
 Home visit on D90 by the PSAD nurse: 
The PSAD nurse carries out this home visit to assess the 
patient's knowledge (continuous technical training and 
reminder of the initial technical training) and confirm their 
best practices. This visit should be carried out before the 
patient's end-of-study visit at the centre. 
 End-of-study visit (D90) by the investigator at the hospital 
centre: 
The patient will visit the hospital service for the end-of-study 
visit, which will include a medical check-up (patient’s metabolic 
balance, efficiency, safety),  assessment of the continued use of 
the system and assessment of the patient's satisfaction and 
experience.  
In theory, 3 visits or telephone calls by PSAD staff are scheduled 
during the first month of post-installation follow-up as part of the 
patient's overall initial training, plus a visit at 3 months. 
Duration of the study 
 
Planned start of the study: Q4 2019 
 
Inclusion of the patients: Q1 2021-Q4 2021 
 
Patient follow-up: 3 months from the date the device is 
installed, at the patient's home 
End of the study (last visit of the last patient to leave the study): Q1 
2022 
Justification for the number of 
subjects 
For reasons of feasibility, the number of patients to be included in the 
study was set at 35, for a number of expected evaluable subjects fixed 
at 32. Should any patients leave the study between the time of 
inclusion and the beginning of the fitting with the closed-loop 
automatic insulin delivery system (or artificial pancreas), they shall be 
replaced. 
This number of patients will be sufficient to estimate the percentage 
of patients satisfied on D90 with their management by the PSAD (the 
primary objective of the study), with an accuracy of ≤ 12.4%.   
In fact, whatever the criterion considered (satisfaction estimated 
from the CSQ-8 and satisfaction assessed from the answers to the 
various questions in the questionnaire "You and your management 
by your home healthcare provider" on D90), the expected percentage 

 
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of satisfied patients is ≥ 85%. The formula used to estimate the 
accuracy is obtained from the definition of the 95% bilateral 
confidence interval (CI 95%) for a proportion, with normal 
approximation 
𝐸= √ (1.96² p (1-p) / n) 
With n=32 evaluable patients, the accuracy will therefore be ≤ 12.4%. 
Statistical methodology The reference population for the statistical analysis will be all of the 
included patients, fitted with the device who meet all of the inclusion 
and exclusion criteria. 
Analysis of the primary criterion: 
The overall CSQ-8 score will be calculated at each time of assessment. 
The percentage of patients satisfied on D30 and D90 and the 
percentage of patients with continued satisfaction on D90 will be 
described. The 95% confidence intervals (CIs) will also be presented.  
The absolute variation of the overall CSQ-8 score and the relative 
variation in relation to D30 will also be described on D90. 
The answers to all the items in the "You and your management by 
your home healthcare provider" questionnaire will be described 
using percentages for the questions with 5 possible choices. Scores 
based on the scales from 1 to 10 will be presented using descriptive 
statistics.   
 
Analysis of the secondary criteria: 
A descriptive statistical analysis of all the secondary parameters will 
be carried out as a whole and according to the study phase when 
applicable (pre-installation, installation and follow-up).  
All questionnaire items will be described using descriptive statistics 
and scores where applicable.  
The evolution of HbA1C will be described at the end of the study. 
Blood sugar parameters will be described at inclusion, on D30 and 
D90.  
To describe patient safety, the incidence rate of all adverse events 
and serious adverse events (SAEs), and those related to the "closed-
loop" automated insulin delivery system (or "artificial pancreas"), will 
be presented as a whole and by "System Organ Class" and "Preferred 
term" in the MedDRA terminology. The number of episodes of severe 
hypoglycaemia requiring the intervention of a third party for glucose 
administration and the number of episodes of hyperglycaemia with 
ketosis will also be described.  
In addition, the number of incidents associated with the device will 
be described. 

 
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TABLE OF CONTENTS 
COORDINATING INVESTIGATOR: ............................................................................................................................... 5 
SPONSOR: ............................................................................................................................................................ 5 
DATA PROTECTION OFFICER: ................................................................................................................................... 5 
RESEARCH AND DEVELOPMENT CENTRE: ................................................................................................................... 5 
 
MEDICAL VICE PRESIDENT............................................................................................................................... 5 
 
DIRECTOR OF REAL WORLD & CLINICAL EVIDENCE ............................................................................................. 5 
 
STUDY PHYSICIAN .......................................................................................................................................... 5 
 
HEAD OF BIOMETRICS .................................................................................................................................... 5 
 
PROJECT MANAGER ....................................................................................................................................... 5 
 
BIOSTATISTICIAN ........................................................................................................................................... 5 
I - INTRODUCTION ................................................................................................................................................ 24 
I.1 - Background ........................................................................................................................................... 24 
I.2 - Medical Devices .................................................................................................................................... 25 
I.3 - Study rationale ..................................................................................................................................... 26 
II - OBJECTIVES OF THE STUDY ......................................................................................................................... 26 
II.1 - Primary objective................................................................................................................................. 26 
II.2 - Secondary objectives ........................................................................................................................... 28 
II.3 - Exploratory objectives ......................................................................................................................... 29 
III - STUDY MODEL................................................................................................................................................ 29 
IV - STUDY POPULATION ........................................................................................................................................ 30 
IV.1 - Eligibility criteria ................................................................................................................................. 30 
IV.1.1 - Inclusion criteria .......................................................................................................................................... 30 
IV.1.2 - Exclusion criteria .......................................................................................................................................... 31 
IV.2 - Patient study period ........................................................................................................................... 31 
IV.3 - Early termination of the study ........................................................................................................... 31 
V - MEDICAL DEVICES ........................................................................................................................................... 33 
V.1 - Presentation of the "closed-loop" automated insulin delivery system (or "artificial pancreas") ....... 33 
V.1.1 - Presentation of the DBLG1™ System by Diabeloop ...................................................................................... 33 
V.1.1.1 - Dexcom G6® sensor and transmitter ......................................................................................................... 34 
V.1.1.2 - Kaleido® insulin pump ............................................................................................................................... 34 
V.1.1.3 - DBLG1TM Terminal ...................................................................................................................................... 34 
V.1.1.4 - YourLoops data visualisation platform ...................................................................................................... 34 
V.1.1.5 - Using the DBLG1TM System ........................................................................................................................ 34 
V.1.2 - Introducing the t:slim X2™ System developed by Tandem Diabetes Care, Inc. ........................................... 35 
V.1.2.1 - Dexcom G6® sensor and transmitter ......................................................................................................... 35 
V.1.2.2 - t:slim X2™ insulin pump............................................................................................................................. 35 
V.1.2.3 - Control-IQ™ technology ............................................................................................................................ 35 
V.1.2.4 - diasend® data visualisation platform ........................................................................................................ 35 
V.1.2.5 - Use of the t:slim X2™ Control IQ™ System ................................................................................................ 35 
V.2 - Management and dispensation of the "closed-loop" automated insulin delivery system (or "artificial 
pancreas") .................................................................................................................................................... 35 
V.2.1 - Distribution – Packaging – Receipt ............................................................................................................... 36 
V.2.2 - Labelling – Storage........................................................................................................................................ 37 

 
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V.2.3 - Prescription and dispensation ...................................................................................................................... 37 
V.2.4 - Management of used and unused equipment ............................................................................................. 38 
V.3 - Duration of treatment ......................................................................................................................... 38 
V.4 - Adherence/Compliance....................................................................................................................... 38 
V.5 - Concomitant treatments / First aid kit / Contraindications ................................................................ 39 
V.5.1 - Concomitant treatments .............................................................................................................................. 39 
V.5.2 - First aid kit .................................................................................................................................................... 39 
V.5.3 - Contraindications .......................................................................................................................................... 39 
VI - ASSESSMENT SCHEDULE .................................................................................................................................. 40 
VI.1 - Study organisation chart .................................................................................................................... 40 
VI.2 - Inclusion visit (Day -15 ± 10 days) ...................................................................................................... 42 
VI.3 - Pre-installation visit(s) by a PSAD nurse (Pre-Inst. 1 / Pre-Inst. 2) ..................................................... 43 
VI.4 - Installation visit(s) at the hospital centre........................................................................................... 44 
VI.5 - Post-installation early follow-up between D1/D3.............................................................................. 45 
VI.6 - Home visit for the first sensor change by the PSAD nurse: ............................................................... 45 
VI.7 - Follow-up on D30 (D30 ± 15 days) ..................................................................................................... 46 
VI.7.1 - Follow-up on D30 by the PSAD nurse .......................................................................................................... 46 
VI.7.2 - Follow-up on D30 by the investigator ......................................................................................................... 47 
VI.8 - Visit on D90 by the PSAD nurse (D90 ± 15 days) ................................................................................ 48 
VI.9 - End-of-study visit ............................................................................................................................... 48 
VI.10 - Assessments and procedures ........................................................................................................... 50 
VI.10.1 - General assessment ................................................................................................................................... 50 
VI.10.2 - Laboratory work-up ................................................................................................................................... 50 
VI.10.3 - Home healthcare provider (PSAD) management ...................................................................................... 51 
VI.10.4 - Description of the study questionnaires.................................................................................................... 52 
VI.10.5 - Patient questionnaires ............................................................................................................................... 52 
VI.10.6 - Patient acquired knowledge assessment questionnaire ........................................................................... 55 
VI.10.7 - Investigator Satisfaction Questionnaire .................................................................................................... 55 
VI.10.8 - PSAD satisfaction questionnaire ................................................................................................................ 57 
VI.10.9 - Metabolic balance ..................................................................................................................................... 57 
VI.10.10 - Safety assessment ................................................................................................................................... 57 
VI.10.11 - Exploratory assessments and procedures – Economic assessment of the service in volume and costs . 58 
VII - EVALUATION CRITERIA .................................................................................................................................... 58 
VII.1 - Primary criterion ............................................................................................................................... 58 
VII.2 - Secondary criteria ............................................................................................................................. 59 
VII.3 - Exploratory criteria ............................................................................................................................ 61 
VIII - VIGILANCE ................................................................................................................................................ 62 
VIII.1 - Definitions ........................................................................................................................................ 62 
VIII.1.1 - Adverse event ............................................................................................................................................ 62 
VIII.1.2 - Adverse Device Effect ................................................................................................................................ 62 
VIII.1.3 - Unexpected Adverse Effect ....................................................................................................................... 62 
VIII.1.4 - Incident ...................................................................................................................................................... 62 
VIII.2 - Classification..................................................................................................................................... 62 
VIII.2.1 - Intensity ..................................................................................................................................................... 62 
VIII.2.2 - Causality .................................................................................................................................................... 63 
VIII.2.3 - Severity ...................................................................................................................................................... 63 
VIII.3 - Recording and Declaring Adverse Events and Incidents .................................................................. 64 
VIII.3.1 - Registering Adverse Events ....................................................................................................................... 64 
VIII.3.2 - Recording Incidents ................................................................................................................................... 64 
VIII.3.3 - Declaration of Serious Adverse Events ...................................................................................................... 65 
IX - PROCESSING OF DATA ..................................................................................................................................... 66 

 
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IX.1 - Case Report Form (CRF) ..................................................................................................................... 66 
IX.2 - Data management .............................................................................................................................. 67 
X - STATISTICAL ANALYSIS ...................................................................................................................................... 68 
X.1 - The sample size ................................................................................................................................... 68 
X.2 - Analysis populations ............................................................................................................................ 68 
X.2.1 - Definition of the populations ........................................................................................................................ 68 
X.2.2 - Deviation from the Protocol ......................................................................................................................... 68 
X.2.3 - Sub-groups .................................................................................................................................................... 68 
X.3 - Statistical analyses ............................................................................................................................... 69 
X.3.1 - General considerations ................................................................................................................................. 69 
X.3.2 - Availability of the patients ............................................................................................................................ 69 
X.3.3 - Demographics and inclusion characteristics ................................................................................................. 69 
X.3.4 - Analysis of the primary assessment criterion ............................................................................................... 69 
X.3.5 - Analysis of secondary assessment criteria .................................................................................................... 70 
X.3.6 - Analysis of the exploratory criteria ............................................................................................................... 71 
X.4 - Managing changes to the initial methods of statistical analysis ......................................................... 73 
XI - QUALITY CONTROL/MONITORING ..................................................................................................................... 73 
XII - RESPONSIBILITIES .......................................................................................................................................... 74 
XII.1 - The sponsor's responsibilities ........................................................................................................... 74 
XII.2 - The investigator's responsibilities ..................................................................................................... 74 
XIII - CONFIDENTIALITY AND ARCHIVING ................................................................................................................... 74 
XIII.1 - Protection of personal data and confidentiality .............................................................................. 74 
XIII.2 - Retention of study documents ......................................................................................................... 75 
XIV - ETHICAL AND REGULATORY CONSIDERATIONS .................................................................................................... 76 
XIV.1 - Patient information leaflet and informed consent form ................................................................. 76 
XIV.2 - Access to source data ....................................................................................................................... 77 
XIV.3 - Conduct of the study ........................................................................................................................ 77 
XIV.4 - Ethics Committee and Relevant Authority ....................................................................................... 77 
XIV.5 - Specific national procedures ............................................................................................................ 77 
XIV.5.1 - Commission Nationale de l’Informatique et des Libertés [French Data Protection Authority] (CNIL) ...... 77 
XIV.5.2 - Conseil National de l’Ordre des Médecins [French National Medical Council] (CNOM) ........................... 77 
XIV.6 - Amendments .................................................................................................................................... 78 
XIV.7 - Audit and Inspection ........................................................................................................................ 78 
XV - PUBLICATION OF DATA ................................................................................................................................... 79 
 
 

 
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LIST OF ABBREVIATIONS  AND DEFINITIONS 
 
Abbreviation 
Definition 
ADE Adverse Device Effect 
ANSM Agence Nationale de Sécurité du Médicament et des Produits de Santé 
[French National Agency for Medicines and Health Products Safety] 
CRA Clinical Research Associate 
BLE Bluetooth Low Energy 
BMQ Beliefs about Medicines Questionnaire 
CBP Clinical Best Practices 
CE European Conformity 
CGM Continuous Glucose Monitoring 
CNIL Commission Nationale de l’Informatique et des Libertés [French Data 
Protection Authority] 
CNOM Conseil National de l’Ordre des Médecins [French National Medical Council] 
CPP Comité de Protection des Personnes [French Ethics Committee] 
CRF Case Report Form 
CRO Contract Research Organisation 
CSP Code de la Santé Publique [French Public Health Code] 
CSQ-8 Client Satisfaction Questionnaire (Overall Satisfaction) 
CV Curriculum Vitae 
DBLG1™ DBLG1™ System: external medical device  
MD Medical Device 
e-CRF Electronic Case Report Form 
SAE Serious Adverse Event 
EQ-5D-5L Quality of life questionnaire 
FFD Fédération Française de Diabétologie [French Federation of Diabetics] 
GSM Global System for Mobile Communications 
HbA1C Glycated haemoglobin 
HFS Hypoglycaemia Fear Survey 
CI Confidence Interval 
ICTA International Clinical Trial Association 
InVS Institut de Veille Sanitaire [French National Institute for Public Health 
Surveillance] 
MRI Magnetic Resonance Tomography 
ISF Investigator Site File 

 
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D Day 
MedDRA Medical Dictionary for Regulatory Activities 
mg/dl Milligram / Decilitre 
ml/min Millilitre/Minute 
MR-001 Reference Methodology - 001 
SAP Statistical Analysis Plan 
SOP Standard Operating Procedures 
Pre-Inst. Pre-Installation 
PSAD Prestataire de Santé à Domicile [Home Healthcare Provider] 
GDPR General Data Protection Regulation 
RIPH Recherche Impliquant la Personne Humaine [Research Involving Human 
Subjects] 
SAS Statistical Analysis System 
TMF Trial Master File 
USADE Unanticipated Serious Adverse Device Effect 
 

 
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I -  INTRODUCTION 
I.1 -  B A C K G R O U N D 
Pathology 
Type 1 diabetes is an auto-immune disease characterised by chronic hyperglycaemia (blood glucose levels 
are too high), caused by the destruction of pancreatic beta cells of islets of Langerhans, which therefore no 
longer produce insulin. The absence of insulin prevents the body from storing and using glucose, exposing 
the individual to a major risk of hyperglycaemia.  
The treatment of type 1 diabetes is based on insulin therapy. For patients, excessive injection of insulin 
causes an increased risk of hypoglycaemia, especially between meals. Such hypoglycaemia can be severe 
and lead to coma.  
In contrast, the absence of insulin followed by a meal or even an insufficient dose of insulin in relation to a 
meal containing carbohydrates can lead to a hyperglycaemic situation. Insulin deficiency can lead to 
diabetes ketoacidosis or even coma.  
Type 1 diabetes accounts for approximately 10% of all diabetes cases and one half of the cases occur in 
children or young adults. In France, the incidence of type 1 diabetes is approximately 15 cases in 100,000 
children under the age of 15. According to the projection model produced by the French National Institute 
for Public Health Surveillance (InVS) on the number of diabetic patients treated in 2006, the number of type 
1 diabetic patients in metropolitan France in 2016 is estimated at between 130,000 and 139,000 (1). 
The proportion of patients treated pharmacologically with antidiabetic medication is rising steadily in 
France, with 3,587,262 patients treated in 2016 and 3,638,223 in 2017, according to Open Data from 
France's National Health Insurance System (2) (3). Diabetes is now the second leading cause of 
cerebrovascular accidents in France and the leading cause of amputation (4). Mortality and the rate of 
sequelae related to complications from diabetes remain very high despite the optimisation of emergency 
care management (5). Indeed, with 11,675 deaths where diabetes was the main cause, this pathology 
accounted for 2.1% of all deaths in France in 2009. Cardiovascular pathologies are said to be responsible for 
two thirds of deaths, and renal complications are the second leading cause of death in diabetic patients (6). 
In economic terms, €19 billion of healthcare expenditure was allocated to diabetic patients (diabetes-related 
or not) in 2014, representing 15% of National Health Insurance expenditure (7). Therefore, owing to its 
prevalence, the complexity of its management, the frequency and severity of its short- and long-term 
complications and the associated mortality, diabetes has a major impact on public health (6). As such, 
diabetes is currently a priority for the development of innovative strategies to optimise its management and 
patient care pathway. 
Treatment 
The treatment of type 1 diabetes is based on the administration of insulin multiple times a day to compensate 
for the body's lack of insulin production. Glucose levels must first be measured, and the doses to be 
administered must be calculated and adapted to the patient's activities, particularly meals and sporting 
activities. Glycaemic control is the primary objective in the management of patients with type 1 diabetes. 
The blood sugar goal advised in most recommendations is an HbA1c level of less than 7% (8). The continuous 
adjustment of insulin doses aims to get as close as possible to normoglycaemia, to avoid hyper and 
hypoglycaemic surges on a daily basis, and to prevent chronic and degenerative microvascular (retinopathy, 
nephropathy, neuropathy, etc.) and macrovascular (coronary heart disease, cerebrovascular disease, 
peripheral arterial disease, etc.) complications over the long term, which are the major cause of morbidity 
and mortality for this pathology. 

 
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The best technique routinely available at present is continuous insulin pump therapy with a rapid-acting 
insulin analogue. Customised algorithms, whose patient-specific parameters are related to base flow rates, 
carbohydrate requirements and physical activity, have also been developed and are available. Nonetheless, 
these techniques cannot be used to manage what is often a very high level of variability from one day to the 
next, and it is currently difficult to achieve complete and prolonged glycaemic control (9); the risk of 
hypoglycaemia is reduced, but is not zero (10). 
The pairing of innovative medical devices, such as insulin pumps with continuous glucose sensors, which take 
regular measurements without patients having to prick their finger, and algorithms for calculating insulin 
doses, has expedited the development of “closed-loop” automated insulin delivery systems (or “artificial 
pancreas"). Data from randomised studies comparing artificial pancreas systems to the standard pump and 
sensor treatment show that time spent in the normoglycaemic target is increased by around 10% and time 
spent in hypoglycaemia is halved (11) (12) (13). 
 
I.2 -  M E D I C A L  D E V I C E S 
In this study, patients are fitted with a "closed-loop" automated insulin delivery system (or "artificial 
pancreas") that has obtained CE marking. 
Several of these systems have been successfully developed and tested in patients with type 1 diabetes. 
Despite their varied clinical and technical factors, they have improved glycaemic control and helped reduce 
the time spent in hypoglycaemia (14).  
Among the “closed-loop” automated insulin delivery systems (or “artificial pancreas”) that have obtained 
CE marking, the study will focus on: 
- 
The DBLG1TM System developed by Diabeloop, which includes a Kaleido® insulin pump with a 
Dexcom G6® continuous glucose monitoring sensor, combined with a dedicated terminal containing 
the Loop Mode algorithm.  
- 
The t:slim X2TM pump, featuring Control-IQ™ technology from Tandem Diabetes Care, Inc., 
combined with a  Dexcom G6® continuous glucose monitoring sensor and a data visualisation system 
for CGM values and insulin flow rates via the diasend® tool. 
The DBLG1TM System is a device that is capable of automatically adjusting the insulin dose to be injected. 
The patient continues to record the meals they have eaten and their sequences of physical activity, but it is 
the algorithm that continuously determines the insulin flow rate adjustments. 
Previous versions of this device have been evaluated, specifically during the SP6.0 Diabeloop Study15 and 
pilot SP7.0 Diabeloop Study (15). In the first study, the main objective was to test the effectiveness and safety 
of the algorithm (v1) during the postprandial period. The study of 12 patients with type I diabetes showed 
that it was a safe and effective semi-automated system for determining the prandial bolus, without exposing 
patients to an excessive risk of hypoglycaemia (9).  In the second study, the objectives were as follows: 1. To 
test the different manual settings available to investigators and patients that have an impact on the 
algorithm's responsiveness; 2. To verify the reliability of the remote monitoring system using an Internet 
platform. This pilot test suggests that the closed-loop system would be effective in terms of metabolic 
outcomes, and that its telemedicine monitoring function could contribute to improving the effectiveness and 
safety of the device (15). 
In a 2-period/3-month crossover study on 63 adults with an initial HbA1c of 7.6%, the Diabeloop consortium 
showed a 9% increase in time spent in the target, and a 1.5% decrease in time spent in hypoglycaemia versus 
4.1% (13).  
The t:slim X2™ insulin pump with Control-IQ™ technology is a Class IIb, CE-marked medical device that is 
capable of automatically adjusting the insulin dose to be injected. The patient continues to record the meals 

 
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they have eaten and their sequences of physical activity, but it is the algorithm (Control-IQ™) that 
continuously determines the insulin flow rate adjustments according to the information relayed by the 
Dexcom G6® CGM. 
The performance of the Tandem t:slim X2™ insulin pump with Control-IQTM technology has been 
demonstrated in two key studies (DCLP3 and DCLP5) involving patients clinically diagnosed with type 1 
diabetes, aged 14 to 71 in the DCLP3 study and aged 6 to 13 in the DCLP5 study. In both studies, all 
participants were equipped with a Dexcom G6® CGM. The t:slim X2™ insulin pump with Control-IQ™ 
technology was compared with  “standard” pump treatment (control group). (16) (17) 
Other studies have also demonstrated the safety and efficacy of the Tandem t:slim X2™ insulin pump with 
Control-IQTM technology in patients (adults and young people) treated for type 1 diabetes. (18) (19) (20) (21) 
 
I.3 -  S T U D Y  R A T I O N A L E  
As with any chronic disease, therapeutic adherence is one of the key aspects of patient management. The 
effectiveness of diabetes treatment requires the patients' therapeutic adherence. Management must 
therefore take into account psychological aspects, including patient satisfaction, well-being and quality of 
life, as well as their understanding of the disease. 
Patients play a key role in diabetes treatment because they are responsible for adapting their daily activities 
to the constraints imposed upon them by the disease. Indeed, they must consider diet, physical activity, 
blood sugar levels and the administration of medication (comorbidities, etc.). This self-management is a 
complex activity since it involves being able to monitor one's state of health and having the cognitive, 
behavioural and emotional reactions necessary to maintain balance and a satisfactory quality of life. While 
care and education have become increasingly patient-centred, many patients still struggle to maintain an 
appropriate level of self-management (22). 
Improving patient satisfaction through high-quality care and support is necessary to help patients and 
improve their capacity for self-reliance, their adherence to the treatment and therefore promote long-term 
glycaemic stability, with the aim of reducing the risk of developing diabetes-related complications. 
In addition, for optimal effectiveness, devices must be well tolerated by patients. Some patients do not 
accept new technologically-advanced alternatives and many studies have reported either discontinued 
treatment or interrupted use. Possible reasons for discontinuing or interrupting use are the differences 
between the clinicians' and patients' perceptions of the associated advantages and disadvantages (23). 
Teaching patients how to use the medical device is essential and indispensable to its proper functioning, and 
to limiting the risks of hypoglycaemia and/or hyperglycaemia. In addition, providing support to diabetic 
patients throughout their treatment ensures the proper use of the medical device and guarantees its 
effectiveness in both the short and long term. 
This study will be used to assess the support given by PSADs to type 1 diabetic patients using a "closed-loop" 
automated insulin delivery system (or "artificial pancreas"), and specifically the satisfaction of the various 
people involved (patients, PSADs, hospital healthcare teams) and their interactions. 
II -  OBJECTIVES OF THE STUDY 
II.1 -  P R I M A R Y  O B J E C T I V E  

 
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The primary objective of the study is to assess the satisfaction and experience of type 1 diabetic patients 
equipped with a "closed-loop" automated insulin delivery system (or "artificial pancreas"), as regards home 
healthcare provider (PSAD) management after 1 and 3 months of follow-up (D30 and D90), under normal 
conditions of use. 
 
 

 
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II.2 -  S E C O N D A R Y  O B J E C T I V E S  
The secondary objectives of this study are as follows: 
Home healthcare provider (PSAD) management 
- 
To describe home healthcare provider management (number, type, time and reasons for interaction), 
according to the various phases of installing a "closed-loop" automated insulin delivery system (pre-
installation, installation, post-installation). 
- 
To compare the management observed  for all the “closed-loop” systems used in the study with the 
theoretical management described in the opinion of the HAS dated 28 January 2020 for the Diabeloop 
DBLG1TM system using the medical device's reimbursement record.  
- 
To assess the knowledge acquired by the patient during their technical training, on D1/D3, D30 and 
D90. 
- 
To describe the satisfaction of the PSAD nurses at the end of the study. 
Patient questionnaires 
- 
To describe the patient's profile in terms of their experience with medical devices, at the time of 
inclusion, and their feelings about their current and future state of health, at inclusion and on D90, in 
order to contextualise the level of patient satisfaction. 
- 
To describe the quality of life of patients and the daily constraints faced by the patient, at inclusion, 
on D30 and on D90, in order to measure the effects of management with a "closed-loop" automated 
insulin delivery system (or "artificial pancreas") and PSAD services on the patient's quality of life. 
- 
To describe the relation to the "closed-loop" automated insulin delivery system (or "artificial 
pancreas"), the benefits expected at inclusion and those perceived on D30 and D90, in order to 
measure the impact of the management on the patient's autonomy and the reduction of their mental 
load. 
Investigator questionnaire 
- 
To describe the satisfaction, assessed at the end of the study, of hospital healthcare teams with PSAD 
patient management in the pre-installation/installation and 3-month follow-up phases, under the 
conditions of use of a "closed-loop" automated insulin delivery system (or "artificial pancreas"). 
- 
To describe, at the end of the study, the interactions between hospital healthcare teams and PSADs 
in terms of frequency and satisfaction. 
- 
To describe, at the end of the study, the benefit of the data visualisation platform for investigators, in 
order to improve patient follow-up. 
Safety 
- 
To describe the safety profile of patients after 3 months of follow-up with the "closed-loop" 
automated insulin delivery system (or "artificial pancreas"). 
Clinical course 
- 
To describe the patient's clinical profile (metabolic balance) and its evolution, at inclusion, on D30 and 
on D90, in order to contextualise the study results. 
 
 

 
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II.3 -  E X P L O R A T O R Y  O B J E C T I V E S 
The exploratory objectives are an economic assessment of the service, in volume and costs, and a sub-group 
assessment based on whether or not such a medical device, or an earlier version, had been used previously. 
Economic assessment of the service, in volume and costs  
- 
To describe the economic indicators of the service at all stages that may generate costs, for example: 
 Cost of training acquired on D1/D3, D30 and D90 
 Cost of acquiring the training according to socio-professional data 
 Average cost of the service for patients without technical incidents  
 Average cost of the service for patients in the event of a technical incident  
 Average total cost of the service for each phase (pre-installation, installation, follow-up): 
 Relative proportion of the cost of failure management in the average cost of the service 
 Relative proportion of the cost of additional training in the average cost of the service 
 Consumption of consumables and associated costs 
 Cost of the automated insulin delivery system 
- 
To describe the quality indicators of the service: 
 Percentage of patients with training validated on D1/D3, D30 and D90  
 Number of calls/patient broken down by call type (technical, medical, etc.): 
 With training validated on D1/D3, D30, D90 
 Without training validated on D1/D3, D30, D90 
 Medical prescription decision-making aid: percentage of patients not eligible for the "closed-
loop" automated insulin delivery system (or "artificial pancreas") following a pre-installation visit 
(assessment of the patient's motivation and ability to use such a system) 
 Percentage of visits following a technical incident call.  
 Time and frequency that the patient’s data is viewed on the platform for the "closed-loop" 
system to detect any technical problems. 
 
Sub-group assessment 
- 
To describe and compare PSAD management and the satisfaction of the various people involved 
(patient, investigator, PSAD) between patients who have already used a "closed-loop" automated 
insulin delivery system (or "artificial pancreas"), versus patients who were device-naive prior to 
inclusion in the study. 
III -  STUDY MODEL 
This is a national, multi-centre, longitudinal, non-comparative interventional study with minimal risks and 
constraints (RIPH2), conducted on patients with type 1 diabetes for whom a "closed-loop" automated insulin 
delivery system (or "artificial pancreas") has been prescribed. 
This study will be conducted in two hospital centres in France. Each centre will work in close collaboration 
with a PSAD representative. 
Investigators, hospital teams and PSAD nurses have been trained in the "closed-loop" automated insulin 
delivery system (or "artificial pancreas") by the system's supplier. 
Patient recruitment will take place over a period of approximately 6 months. Recruitment will end once 35 
patients are fitted with a "closed-loop" automated insulin delivery system (or "artificial pancreas"). 

 
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The included patients will be monitored for a period of 3 months, starting from the end of the medical device 
installation procedure, or once the patient returns home. The management proposal consists of three distinct 
phases: pre-installation, installation and follow-up.  
During these three phases, the number and duration of interactions (visits/telephone calls) may vary 
according to the patient's needs, the investigator's judgement and practice, and the judgement of PSAD staff. 
IV -  STUDY POPULATION 
IV.1 -  E L I G I B I L I T Y  C R I T E R I A 
Patient selection is based on the following inclusion and exclusion criteria. Patients who meet all of the 
inclusion criteria and none of the exclusion criteria are eligible to participate in this study. 
IV.1.1 -  I N C L U S I O N  C R I T E R I A  
1. Type 1 diabetic patient diagnosed for at least 2 years 
2. Patient treated with an external insulin pump for at least 6 months 
3. Patient with an HbA1c level less than or equal to 10% in the past 4 months (assay performed in a 
medical analysis laboratory or equivalent) 
4. Patient with U-100 rapid-acting insulin (Novorapid or Humalog) requirements between the upper 
and lower bounds set by the pump of the "closed-loop" automated insulin delivery system (or 
"artificial pancreas") 
5. Patient who is not isolated, who does not live alone or who has a "resource" person living nearby 
with his/her own telephone and a key to the patient’s house 
6. Patient living in an area covered by a GSM (Global System for Mobile Communications) network and 
not planning to travel outside France or outside an area covered by a GSM network within 30 days 
of the "closed-loop" automated insulin delivery system (or "artificial pancreas") being installed 
7. Patient at least 18 years old and whose age complies with the eligibility criteria for each medical 
device of the "closed-loop" automated insulin delivery system (or "artificial pancreas")  
8. Patient registered with a Social Security system 
9. Patient who has agreed to comply with the requirements of the study and has signed the free and 
informed consent form 
10. Patient who the investigator deems capable of using a "closed-loop" automated insulin delivery 
system (or "artificial pancreas") under normal conditions of use. 
 
 

 
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IV.1.2 -  E X C L U S I O N  C R I T E R I A 
1. Patient with any serious pathology that could affect his/her participation in the study 
2. Patient undergoing treatment that could affect the physiology of diabetes, i.e., that leads to 
interactions with glucose and/or insulin, in the investigator's judgement 
3. Patient benefiting from a legal protection measure 
4. Pregnant or breastfeeding woman 
5. Absence of contraception deemed effective by the investigator for a woman of childbearing age 
6. Psychological and/or physical state which could affect the proper monitoring of the study 
procedures 
7. Severe hypoglycaemia which has led to convulsions or a loss of consciousness in the last 12 months 
8. Decrease in the perceived sensation of hypoglycaemia, in the investigator's judgement 
9. Impaired renal function (creatinine clearance < 30 ml/min measured in the last 6 months) 
10. Patient who has had a pancreas or pancreatic islet transplant 
11. Patient with serious uncorrected hearing and/or visual problems 
12. Patient included in another clinical study or who has taken part in another clinical study in the last 
30 days. 
IV.2 -  P A T I E N T  S T U D Y  P E R I O D  
The study is scheduled to begin in Q1 2021 and patient recruitment will be conducted over a period of 
approximately 6 months. 
Patients will be monitored for a period of 3 months, starting from the end of the device installation 
procedure, at the patient's home and consequently upon the patient's return home, which is estimated as 
taking place within 15 + 10 days of inclusion. 
It is therefore estimated that the study will end with the last visit of the last patient to leave the study (Last 
Patient Last Visit) in Q3 2020. 
IV.3 -  E A R L Y  T E R M I N A T I O N  O F  T H E  S T U D Y 
Temporary or definitive early termination of the study 
The study may be stopped early, either temporarily or definitively, at any time at the request of the sponsor, 
the French Ethics Committee (CPP) or the relevant authority, the French National Agency for Medicines and 
Health Products Safety (ANSM). In such a case, the sponsor will inform the investigator of the decision to 
temporarily or definitively stop the study who must inform the patients as soon as possible. The investigator 
will complete the e-CRF with the data available on the day the study ends.  
The sponsor must report the study's termination to the ANSM and the CPP, in accordance with national 
regulatory requirements, specifying the reason for this termination.  
Early termination of the study for a patient 
Patients have the right to withdraw from the study at any time and for any reason, without prejudice to their 
future medical monitoring. They will then have the device removed. All data collected up to the time they 
leave the study will be kept for analysis, but no other data concerning them will subsequently be collected. 
 
 

 
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For each patient, it will be specified whether they terminated the study early for any of the following reasons: 
- 
Adverse event. 
- 
Withdrawal of consent. 
- 
Patient lost to follow-up. 
- 
Non-compliance with at least one inclusion/exclusion criterion. 
- 
Investigator's decision: 
o Patient considered unfit by the investigator  
o Other, to be specified 
- 
Other, to be specified. 
In the event of early termination of the study for a patient, the information (date and reason for leaving) will 
be reported by the investigator in the patient's medical file and entered in the e-CRF. In the event of early 
termination of the study due to an adverse event, the adverse event will be followed up until it is resolved 
or stabilised. 
 
 

 
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V -  MEDICAL DEVICES 
V.1 -  P R E S E N T A T I O N  
O F  
T H E  
" C L O S E D - L O O P"  
A U T O M A T E D  
I N S U L I N  
D E L I V E R Y  S Y S T E M  ( O R  " A R T I F I C I A L  P A N C R E A S ") 
In this study, patients will be fitted with a "closed-loop" automated insulin delivery system (or "artificial 
pancreas"). 
This system combines 3 medical devices:  
- 
An insulin pump,  
- 
A continuous glucose sensor (CGM),  
- 
And an algorithm that continuously calculates the amount of insulin needed for glycaemic control 
and controls the insulin pump.  
To help keep the patient's glucose levels as close to the desired value (e.g. 120 mg/dl) as possible, and within 
the target (e.g. between 70 and 180 mg/dl), the CGM measures the glucose concentration approximately 
every 5 minutes. The measured glucose value is transmitted from the sensor to the algorithm via Bluetooth.  
The algorithm compares this value with the set target value and calculates:  
- 
Either the insulin requirement based on the difference between the glucose value and the target 
value. According to the result, the pump's base flow rate adapts to each measurement (increase or 
decrease). 
In this case, the insulin pump receives the command to deliver the specific quantity of insulin and 
the subcutaneous injection begins. 
- 
Or the sugar requirement, if the glucose value is lower than the target value.  
The algorithm then prompts a patient alert on the control module/terminal, recommending they 
ingest a given quantity of sugar and asking them to confirm they have ingested the recommended 
quantity of sugar.  
Glucose concentration measurements continue every 5 minutes and the system ensures the correct decision 
is made by continuously calculating the amount of insulin needed for glycaemic control and sending this 
command to the insulin pump. The system is thus able to automatically adjust the dose of insulin to be 
injected and only requires the patient's intervention for meals or exercise. The patient records their meals, 
and the algorithm recommends a bolus which they must confirm. The patient records their physical activity, 
and the algorithm factors this information in to adjust its calculation. 
Among the “closed-loop” automated insulin delivery systems (or “artificial pancreas”) that have obtained 
CE marking, the study will use the DBLG1TM and the t:slim X2™ pump with Control IQ™ technology. 
V.1.1 -  P R E S E N T A T I O N  O F  T H E  DBLG1™ S Y S T E M  B Y  D I A B E L O O P 
The DBLG1TM System (developed by Diabeloop), which includes a Kaleido® insulin pump with a Dexcom G6® 
continuous glucose monitoring sensor, combined with a dedicated terminal containing the Loop Mode 
algorithm, is a "closed-loop" automated insulin delivery system (or "artificial pancreas") with CE marking. 
 
 

 
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V . 1 . 1 . 1  -  D E X C O M  G6®  S E N S O R  A N D  T R A N S M I T T E R 
The Dexcom G6® System is a medical device used to continuously monitor glucose levels and how fast they 
are changing (CGM, Continuous Glucose Monitoring). It consists of an applicator with integrated sensor and 
a transmitter that sends the glucose concentration values from the sensor to the terminal via Bluetooth Low 
Energy (BLE) wireless communication. 
Interstitial glucose measurements are taken using a disposable sensor (replaced every 10 days) that is 
inserted just beneath the skin of the abdomen. The values can be viewed on the terminal and are updated 
every five minutes. The measurement interval is 40-400 mg/dl. 
The transmitter's operating life is 3 months. 
Unlike other continuous glucose sensors, Dexcom G6® is not contraindicated for use with medications 
containing acetaminophen (paracetamol). 
V . 1 . 1 . 2  -  K A L E I D O ®  I N S U L I N  P U M P  
The Kaleido® insulin pump is a medical device that delivers the insulin needed to maintain glycaemic control. 
It ensures a reproducible injection of insulin by always using the same injection depth and injection rate for 
a period of 3 days at the same site. After 3 days, the infusion site, insulin cartridge and pump must be 
changed. 
The pump is connected to the terminal via BLE wireless communication. Insulin delivery by the pump is 
controlled by the DBLG1TM algorithm. 
V . 1 . 1 . 3  -  DBLG1 T M  T E R M I N A L 
The DBLG1TM terminal is a medical device that displays interstitial glucose values and contains an algorithm 
to recommend and program insulin injection according to specific rules.  
The terminal is used to collect, view and store glucose measurements transmitted by Dexcom G6® every 5 
minutes. It also allows data provided by the patient to be collected, such as meal and/or physical activity 
reports. The algorithm uses these data to automatically calculate the insulin doses and commands the 
Kaleido® pump to inject them. The system adjusts the insulin flow rates every 5 to 10 minutes. 
This automated insulin injection decision-making process is active when the pump is connected to the 
terminal with the Loop Mode function activated, which is referred to as a "closed loop" or "closed circuit". 
When the Loop Mode function is disabled, the pump can be controlled manually using the trend arrows on 
the terminal display. The patient remains in control of their treatment, which is referred to as an "open loop" 
or "open circuit". 
V . 1 . 1 . 4  -  Y O U RL O O P S  D A T A  V I S U A L I S A T I O N  P L A T F O R M  
A data visualisation platform called YourLoops is used to view the data collected by the DBLG1TM terminal. 
The patient systematically accesses it. The patient is responsible for sharing their data with the investigator 
or any other person they choose. 
V . 1 . 1 . 5  -  U S I N G  T H E  DBLG1 T M  S Y S T E M 
With the DBLG1TM System, the patient receives a user manual that describes how to use the system.  

 
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V.1.2 -  I N T R O D U C I N G  T H E  T : S L I M  X2™ S Y S T E M  D E V E L O P E D  B Y  
T A N D E M  D I A B E T E S  C A R E,  I N C. 
t:slim X2™ is a “closed-loop” automated insulin delivery system (or “artificial pancreas”) developed by 
Tandem Diabetes Care, Inc. with a Class IIb CE mark. It consists of an insulin pump with a closed-loop 
algorithm, i.e. the Tandem t:slim X2™ insulin pump with Control-IQ™ technology, combined with a Dexcom 
G6® continuous glucose monitoring sensor (a Class IIb, CE-marked medical device) and a diasend® 
visualisation platform with a Class I CE mark. 
V . 1 . 2 . 1  -  D E X C O M  G6®  S E N S O R  A N D  T R A N S M I T T E R 
See section V.1.1.1 
V . 1 . 2 . 2  -  T: S L I M  X2™ I N S U L I N  P U M P  
The t:slim X2™ insulin pump is paired with a 3-ml (300 unit) t:slim cartridge and a compatible infusion set.  
The disposable cartridge is filled with up to 300 units of U-100 insulin and attached to the pump. The cartridge 
should be replaced every 48 to 72 hours. 
The pump delivers insulin in two ways: basal (or continuous) insulin delivery and bolus insulin delivery.  
The t:slim X2™ pump has an automated insulin dosing function that allows the t:slim X2™ system to 
automatically adjust insulin delivery based on CGM measurements,although this feature does not replace 
active management of diabetes by the patient. The automated insulin dosing function uses the readings from 
the CGM sensor to predict blood sugar values over the next 30 minutes.  
V . 1 . 2 . 3  -  C O N T R O L -IQ™ T E C H N O L O G Y 
Control-IQ™ technology is built into the t:slim X2™ pump, which automatically adjusts insulin flow rates and 
quantities in response to readings from a CGM sensor. 
V . 1 . 2 . 4  -  D I A S E N D®  D A T A  V I S U A L I S A T I O N  P L A T F O R M 
diasend®, a medical device by Glooko, is intended for use by individuals, healthcare professionals and 
healthcare facilities for data transmission between home monitoring devices, such as blood sugar meters 
and insulin pumps, and a database on a server to assist in the management of diabetes.  
diasend® will be used in the research in conjunction with the Tandem insulin pump and Dexcom G6® glucose 
sensor in accordance with its user guide. 
V . 1 . 2 . 5  -  U S E  O F  T H E  T : S L I M  X2™ C O N T R O L  IQ™ S Y S T E M 
With the “closed-loop” automated insulin delivery system (or “artificial pancreas”) developed by Tandem 
Diabetes Care, Inc., the patient is provided with user manuals that detail how to use the system. Patients 
should be instructed to always use the system components (pump, cartridges, CGM, infusion sets and 
visualisation platform) according to their respective instructions. 
 
V.2 -  M A N A G E M E N T  
A N D  
D I S P E N S A T I O N  
O F  
T H E  
" C L O S E D- L O O P"  

 
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A U T O M A T E D  I N S U L I N  D E L I V E R Y  S Y S T E M  ( O R  " A R T I F I C I A L  P A N C R E A S ") 
V.2.1 -  D I S T R I B U T I O N  –  P A C K A G I N G  –  R E C E I P T 
Distribution 
The sponsor orders the medical devices (MDs) and consumables required to operate the system from the 
supplier(s) of the "closed-loop" automated insulin delivery system (or "artificial pancreas").  
The supplier of the "closed-loop" automated insulin delivery system (or "artificial pancreas") does not supply 
insulin; the patient must purchase it directly from their retail pharmacy. This also applies to the contents of 
the first aid kit. 
The supplier sends the MDs and consumables to the PSADs in their commercial form with a unique 
identification number.  
Packaging 
The equipment (MDs and consumables) is packaged in boxes and identified by a serial and/or batch number.  
Each of the components that make up the system can be supplied separately, as replacement equipment 
and/or consumables. 
As such, throughout the study and according to patient needs and PSAD requests, the system supplier(s) will 
send the consumables and/or replacement equipment to the PSADs in their commercial form. 
Receipt 
Upon receipt, the PSADs electronically record the boxes received — identified by a unique number — in their 
information system. The date of receipt is also entered electronically. An acknowledgement of receipt will 
be sent to the sponsor or their representative and kept in the sponsor's Trial Master File (TMF). 
In the event of a defect or damage to the boxes supplied, including the packaging, the PSADs shall inform the 
supplier within 24 working hours.  
In the event of a batch recall, the supplier shall notify the PSADs and indicate the procedure to be followed. 
The PSADs will inform the sponsor and the investigator. 
 
 

 
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V.2.2 -  L A B E L L I N G  –  S T O R A G E 
Labelling 
As the equipment (MDs, consumables and replacement equipment) will be received in its commercial form, 
the PSADs will label them for exclusive use in a clinical study as soon as they are received.  
Storage 
The equipment will then be stored in a ventilated room, in a location dedicated to the study and in 
accordance with their specific storage conditions (see storage conditions in the system's user manual).  
The PSADs will document any temperature excursions and any non-compliance with the storage conditions 
required for the equipment supplied in their file, as well as corrective and preventive actions where 
applicable.  
V.2.3 -  P R E S C R I P T I O N  A N D  D I S P E N S A T I O N 
The investigator and PSAD nurse should only use the study MDs and consumables for patients who have 
consented to participate in the study. They shall neither use nor authorise use of the study MDs and 
consumables in circumstances other than those described in this Protocol. 
During the inclusion visit, the investigator will submit the request for management and initiation by the PSAD. 
If the investigator considers the patient is motivated and able to use the "closed-loop" automated insulin 
delivery system (or "artificial pancreas"), the PSAD assigns the patient a "closed-loop" automated insulin 
delivery system (or "artificial pancreas"). 
Boxes previously labelled for use in a clinical study are brought by the PSAD nurse and given to the patients 
involved on the first day of installation in the hospital. 
Nonetheless, at the investigator's request, the sensor can be fitted prior to installing the complete "closed-
loop" automated insulin delivery system (or "artificial pancreas"), and this can be done at the patient's home, 
in the presence of the PSAD nurse. In this case, the PSAD nurse brings the assigned sensor box to the patient's 
home and helps the patient fit the sensor.  
The PSADs maintain a record of the MDs and consumables assigned to the patients included in the study, 
with the following information: 
- 
The study reference. 
- 
The reference of the patient (including the patient's number in the study) to whom the "closed-loop" 
automated insulin delivery system (or "artificial pancreas") was distributed. 
- 
Patient delivery dates, quantity and number of MDs and consumables delivered to the patient (initial 
shipment, replenishment or replacement). 
- 
Return and destruction dates, quantity and number of MDs and consumables that were either used, 
partially used or never used by the patient (see V.2.4 management of used or unused equipment). 
This information will also be recorded in the e-CRF. 
 
 

 
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V.2.4 -  M A N A G E M E N T  O F  U S E D  A N D  U N U S E D  E Q U I P M E N T  
At the end of the study, the PSAD will collect any unused or partially used MDs and consumables supplied. 
As empty boxes or packaging will not be collected, they will be considered used. The PSAD will then conduct 
an accurate inventory and reconciliation of the MDs and consumables that were assigned to patients with 
the equipment that was used, partially used or unused.  
Once the batch reconciliation is updated, and with the explicit agreement of the sponsor or the sponsor's 
representative, the equipment may then be destroyed and/or recycled according to the procedures the 
supplier has given to the PSAD.  
During destruction and/or recycling, a destruction/recycling certificate must be completed and include the 
following information: 
- 
The reference of the study equipment (MDs, consumables and/or replacement equipment) that was 
destroyed/recycled (batch number). 
- 
Quantity destroyed/recycled. 
- 
Date and method of destruction/recycling. 
- 
Name and signature of the individual (or company) responsible for destroying/recycling the study 
equipment. 
Batch reconciliation and destruction/recycling certificates will be kept in the PSAD's study file, the 
Investigator Site File (ISF) and the sponsor's Trial Master File (TMF).  
At the end of the study, for each of the patients involved, the sponsor undertakes to take all possible 
measures towards ensuring continuity of the care chain. 
V.3 -  D U R A T I O N  O F  T R E A T M E N T  
The "closed-loop" automated insulin delivery system (or "artificial pancreas") will be used according to the 
instructions provided in the user manual and summarised above, during the 3-month follow-up period, 
unless the study is terminated early (see section IV.3).  
V.4 -  A D H E R E N C E /C O M P L I A N C E 
Patient adherence and compliance are assessed using the "Patient acquired knowledge assessment" 
questionnaire (see section VI.10.5), completed by the PSAD nurse, at each visit/interaction during the 
patient's follow-up period, by asking the patient about their use of the "closed-loop" automated insulin 
delivery system (or "artificial pancreas"), including regular physical activity and meals. 
The time spent in a "closed loop", which the investigator gathers via the data visualisation platform, also 
documents patient adherence and compliance.  
 
 

 
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V.5 -  C O N C O M I T A N T  T R E A T M E N T S  /  F I R S T  A I D  K I T  /  C O N T R A I N D I C A T I O N S 
V.5.1 -  C O N C O M I T A N T  T R E A T M E N T S   
Since the purpose of this study is to assess PSAD support for patients equipped with an automated "closed 
loop" insulin delivery system (or "artificial pancreas"), and not to assess the effectiveness of the system itself, 
it is the clinical investigators' responsibility to establish the treatment(s) required for proper patient 
management in accordance with the rules of clinical best practices and the recommendations described in 
the user manual. Please note: treatments that could affect the physiology of diabetes, i.e. that lead to 
interactions with blood sugar and/or insulin and are thus liable to interfere with the action of “closed-loop” 
automated insulin delivery systems (or “artificial pancreas”), are not authorised for use in patients equipped 
with these systems (e.g. steroid treatment).  
V.5.2 -  F I R S T  A I D  K I T 
In case one or more of the "closed loop" automated insulin delivery system (or "artificial pancreas") 
components fails, the patient must carry a first aid kit at all times. The contents of the first aid kit are 
described in the system user manual. It contains, at least: 
- 
A spare insulin cartridge 
- 
An infusion set 
- 
A blood sugar meter with its test strips 
- 
A lancing device 
- 
A means of administering glucose 
- 
Ketone test strips for measuring ketones  
V.5.3 -  C O N T R A I N D I C A T I O N S  
The "closed-loop" automated insulin delivery system (or "artificial pancreas") cannot be used in the presence 
of magnetic fields, including storage cabinets with magnet locks, MRIs, X-rays and CT scans. Magnetic fields 
can cause damage to sensors and induce display errors in glucose concentration values or block alerts.  
The "closed-loop" automated insulin delivery system (or "artificial pancreas") cannot be used in the presence 
of ionising radiation or during radiotherapy.  
Should any of these cases arise, the system must be removed beforehand to keep it safe. 
The use of accessories other than those supplied with the system is prohibited. 
 
 
 

 
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VI -  ASSESSMENT SCHEDULE 
Management consists of three distinct phases: pre-installation, installation and follow-up. During these three 
phases, the number and duration of interactions (visits/telephone calls) may vary according to the patient's 
needs, the investigator's judgement and practice, and the judgement of PSAD staff.  
The pre-installation and installation phases include 2 patient visits to the hospital centre, and 2 to 5 visits 
by the PSAD (at home and at least one in the hospital centre).  
The end of the patient's hospitalisation and their return home, i.e. the end of the installation phase, shall be 
considered to be D0 for patient follow-up. 
The follow-up phase (post-installation) includes 4 interactions with the PSAD, on the telephone and/or at 
home, and 1 hospital centre visit by the patient. 
 
Based on the investigator's clinical judgement, a urinary pregnancy test may be performed, at any time during 
the study, to ensure that no pregnant patients have been involved or retained during the conduct of the 
study.  
VI.1 -  S T U D Y  O R G A N I S A T I O N  C H A R T 

 
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The schedule of study procedures and assessments is summarised in the table below. 
Study phase 
Pre-installation (Pre-Inst.) 
Installationa 
Post-installation 
 
Inclusion 
D-15 
Pre-Inst. 1 
/ Pre-Inst. 
2 
Additional 
interaction 
Installation 
(end = D0) 
D1 / D3 
1st sensor 
change 
D30 
(1 month) 
Additional 
interaction 
D90 
(3 months) 
End of the study: D90 
(3 months) 
(or early withdrawal) 
Day / Location 
+/-10 days 
Hospital 
Home 
Home 
or Telephone: 
Hospital 
 
Home or 
Telephone 
Home  
+/-15 days 
Home/  
Hospital 
or 
Telephone 
Home or 
Telephone 
+/-15 days 
Home 
+/-15 days 
Hospital 
Number of PSAD scheduled 
interactions  
0 
1 to 2 pre-installation visits  
+ 1 to 3 installation visits 
4 interactions 
Information and signed consent 
X 
 
 
 
 
 
 
 
 
 
Inclusion and exclusion criteriab, c 
X 
 
 
 
 
 
 
 
 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
Socio-professional data 
X 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
HbA1c 
(Xd) 
 
 
Xd 
 
 
 
 
 
X 
Metabolic balancee  
X 
 
 
 
 
 
X 
 
 
X 
Urinary pregnancy test 
Xb 
 
 
 
 
 
 
 
 
 
Creatinine or creatinine clearance 
Xc 
 
 
 
 
 
 
 
 
 
Sensor fitting  
 
(Xf) 
 
Xf 
 
 
 
 
 
 
Installation of the "closed-loop" 
automated insulin delivery system (or 
"artificial pancreas") 
 
 
 
X 
 
 
 
 
 
 
Evaluation of the patient's continued 
use of the system 
 
 
 
 
 
 
X 
 
 
X 
Replenishment of consumables 
requested by the patient, if necessary 
 
 
 
 
Xg 
Adverse events (adverse events, SAEs) 
/ Incidents 
Xh 
Xh 
Xh 
X 
X 
X 
X 
X 
X 
X 
Patient acquired knowledge 
assessment questionnaire, completed 
by the PSAD 
 
 
 
 
X 
 
X 
 
X 
 
Hospital healthcare team satisfaction 
questionnaire 
 
 
 
 
 
 
 
 
 
Xi 
PSAD satisfaction questionnaire 
 
 
 
 
 
 
 
 
Xi 
 
Patient questionnaires 
X 
 
 
 
 
 
X 
 
 
X 

 
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a: The installation is performed in hospital, during a scheduled hospital stay or outpatient visit, over a period of 2 to 3 
days. D0 represents the end of the installation, i.e. the day the patient returns home with the "closed-loop" automated 
insulin delivery system (or "artificial pancreas") installed. 
b: Including a urine pregnancy test for women of childbearing age. 
c: If a creatinine clearance measurement from less than 6 months ago is not available in the patient's medical file, the 
assay must be performed at inclusion to confirm the patient's participation in the study. 
d: If an HbA1c measurement (performed in a medical analysis laboratory or equivalent) that is less than 4 months old is 
not available in the patient's medical file, the inclusion criterion will be confirmed by an assay performed at the inclusion 
visit. In this case, the HbA1c assay will not be repeated at the time of installation, and the value of the inclusion assay 
will be used as a reference at installation. 
e: Metabolic balance includes the daily average blood sugar level and its variability, the time spent in hyperglycaemia 
(>180 mg/dl, [180-250 mg/dl] and > 250 mg/dl), normoglycaemia [70-180 mg/dl] and hypoglycaemia (<70mg/dl, [54-70 
mg/dl] and < 54 mg/dl), and % of time spent in closed loop (if available). 
f: At the prescriber's request, the sensor can be installed prior to installing the complete "closed-loop" automated insulin 
delivery system (or "artificial pancreas"), and this can be done either in hospital by hospital staff or at the patient's home 
during a pre-installation visit by the PSAD nurse. 
g: At the patient's request. 
h: Collection of adverse events only (unless the sensor is installed during the pre-installation phase). 
i: Completed once, at the end of the study (after the last patient has left the centre). 
 
 
Details of the patient questionnaires 
 
Inclusion 
D30 
End of the study - D90 
(or early withdrawal) 
You and the "closed-loop" automated insulin delivery system (or "artificial 
pancreas") (Expected benefits / Perceived benefits) 
X 
X 
X 
You and your quality of life with diabetes (EQ-5D-5L (24) (25) (26))  
X 
X 
X 
You and your beliefs about the medical treatment (BMQ (27) – specific 
section only) 
X 
X 
X 
You and medical devices (Patient profile / MD experience) 
X 
 
 
You and your health (Patient profile / state of health) 
X 
 
X 
You and your daily constraints 
X 
X 
X 
You and your management in general (CSQ-8 (28) (29): Overall 
satisfaction) 
 
X 
X 
You and your management by your home healthcare provider 
(Proactiveness / availability / PSAD advice) 
 
X 
X 
You and your quality of life and daily constraints linked to the risk of 
hypoglycaemia episodes (HFS-II) (30) (31) 
X 
X 
X 
VI.2 -  I N C L U S I O N  V I S I T  (D A Y  -15  ±  10  D A Y S) 
An investigator carries out the patient's inclusion visit in the hospital centre. 
Patients meeting the eligibility criteria are invited to participate in the study.  
The investigator then gives the patient an information leaflet and explains the study (procedure, objectives, 
benefits and risks, etc.) and answers any questions they may have. If the patient agrees to participate in the 
study, they give their free and informed consent by dating and signing the consent form. The information will 
be transferred to the patient's source file, and the study procedures described below can begin (see details 
in section VI.10): 
- 
Demographic data 
- 
Socio-professional data 
- 
History of diabetes including date of diagnosis and complications 
- 
Medical history / Comorbidities 

 
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- 
Diabetes management including the date of first pump use, daily U-100 rapid-acting insulin 
requirement, prior use of an automated "closed loop" insulin delivery system ("artificial pancreas") 
and, where relevant, whether there was a change of healthcare provider at inclusion 
- 
Urinary pregnancy test for women of childbearing age 
- 
Creatinine blood test, if a value taken less than 6 months ago is not available in the patient's medical 
file 
- 
HbA1c blood test, if a test value taken from a medical analysis laboratory or equivalent less than 4 
months ago is not available in the patient's medical file 
- 
Metabolic balance over a period of 4 weeks including (see section VI.10.9):  
- 
Daily average blood sugar level and its variability (standard deviation and coefficient of 
variation, if applicable)  
- 
Time spent if available (as a percentage):  
- 
In hyperglycaemia (> 180 mg/dl), [180-250 mg/dl] and > 250 mg/dl  
- 
In the blood sugar target [70-180 mg/dl] 
- 
In hypoglycaemia (< 70 mg/dl), [54-70 mg/dl] and < 54 mg/dl 
- 
Patient Inclusion Booklet including the following questionnaires: 
 
You and the "closed-loop" automated insulin delivery system (or "artificial pancreas") (Expected 
benefits) 
 
You and your quality of life with diabetes (EQ-5D-5L) 
 
You and your beliefs about the medical treatment (BMQ – specific section only) 
 
You and medical devices (Patient profile / MD experience) 
 
You and your health (Patient profile / state of health) 
 
You and your daily constraints  
 
You and your quality of life and daily constraints linked to the risk of hypoglycaemia episodes 
(HFS-II) 
- 
Adverse events, data collection begins as soon as the patient agrees to participate in the study 
The data are recorded in the e-CRF by the investigator or a member of the hospital team delegated by the 
investigator at the time of the visit, so that the sponsor and their representative are informed of the patient's 
inclusion. 
The investigator makes the request for management and initiation by the PSAD. 
This inclusion visit is the first stage of the pre-installation phase. 
VI.3 -  P R E- I N S T A L L A T I O N  V I S I T ( S)  B Y  A  PSAD  N U R S E  (P R E-I N S T.  1  /  P R E-
I N S T.  2) 
The second stage of the pre-installation phase is the patient's management by the PSAD through one or two 
home visits to present the "closed-loop" automated insulin delivery system (or "artificial pancreas") to the 
patient, and assess their motivation and ability to use such a system. 
The interview includes: 
- 
The patient’s initial technical training, including:  
o Learning how the system works as a whole, with both simple and advanced functions, 
including how each component works, and how to use the platform. 
o How to use the consumables and knowledge of the safety rules. 
o How to respond to alarms and equipment malfunctions. 
o Routine maintenance of the equipment. 
o Precautions for use. 

 
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o Ways of wearing the pump and sensor.  
o Knowledge of the medical on-call procedure, including the various telephone numbers, 
the replacement scheme and emergency kit.  
- 
Assessment of the patient’s ability to use the control module/terminal with which the system's 
algorithm works. 
- 
The collection of any adverse events that have occurred since the inclusion visit. If an adverse event 
is reported, the PSAD nurse passes the information on to the investigator for patient assessment 
and monitoring if necessary. 
 
After the visit(s), the PSAD nurse sends the investigator a written report with their assessment of the patient's 
motivation and ability to use the "closed-loop" automated insulin delivery system (or "artificial pancreas"). If 
the investigator ultimately deems the patient unfit to use this "closed loop" system, it will be considered a 
selection failure and the patient will be discharged from the study.  
After each interaction with the patient, the PSAD nurse electronically records this interaction in the PSAD 
files and also completes the e-CRF. If additional interactions, either at home or by telephone, are required 
between the patient and the PSAD nurse during the pre-installation phase, these will also be electronically 
recorded in the PSAD files and entered in the e-CRF in compliance with the PSAD management procedure 
(VI.10.3). 
VI.4 -  I N S T A L L A T I O N  V I S I T ( S)  A T  T H E  H O S P I T A L  C E N T R E 
Once the patient's motivation and ability to use the medical device have been established, the installation 
phase begins.  
The "closed-loop" automated insulin delivery system (or "artificial pancreas") will be installed during a 
scheduled hospital stay (or outpatient visits) in the hospital centre for a variable duration, estimated between 
2 and 3 days. 
The estimated number of installation visits carried out by the PSAD is between 1 and 3 during the installation 
phase, including at least one visit to the hospital centre.  
The boxes (medical devices and consumables), which have already been labelled for use in a clinical study, 
are brought into the hospital by the PSAD nurse.   
The procedures below are performed exclusively by the hospital teams: 
- 
HbA1c blood test, unless the test had to be performed at inclusion. In this case, the HbA1c assay will 
not be repeated at the time of installation, and the value of the inclusion assay will be used as a 
reference at installation. 
- 
Installation of the "closed-loop" automated insulin delivery system (or "artificial pancreas") 
(including the insulin pump). 
- 
Collection of any adverse events and SAEs / incidents. 
 
The following procedures may be fully or partially delegated to the PSAD: 
- 
Assistance with sensor installation, if not previously installed. At the prescriber's request, the sensor 
can be installed prior to installing the complete "closed-loop" automated insulin delivery system (or 
"artificial pancreas"), and this can be done either in hospital by hospital staff or at the patient's home 
during a pre-installation visit by the PSAD nurse. 
- 
Technical training on how to use the "closed-loop" automated insulin delivery system (or "artificial 
pancreas") and associated consumables.  
- 
Assistance with signing up to the platforms for the closed-loop systems and pairing their medical 
devices. 
 

 
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The data are written down in the patient's source file and recorded in the e-CRF by the investigator or a 
member of the hospital team delegated by the investigator. The PSAD nurse electronically records their 
hospital visits in the PSAD files and also completes the e-CRF. 
Once the "closed loop" automated insulin delivery system (or "artificial pancreas") has been installed, the 
patient does not keep their previous equipment and contacts the PSAD who usually monitors them to arrange 
its return. 
The patient received the system and associated consumables for a period of time established between the 
patient and the PSAD nurse. Replenishment will be based on the patient's needs, as explained in section V.2.  
However, should any problems arise with a defective system, the investigator will check the equipment and, 
if necessary, provide a prescription for the replacement scheme. The investigator also provides instructions 
for completing the questionnaires on D30 and gives the patient the corresponding booklet and pre-paid 
envelope for returning the completed questionnaires.  
The end of the patient's hospitalisation and their return home, i.e. the end of the installation phase, shall be 
considered to be D0 for patient follow-up. 
On-call technical support and maintenance support by the PSAD is available 24 hours a day, 7 days a week. 
VI.5 -  P O S T- I N S T A L L A T I O N  E A R L Y  F O L L O W- U P  B E T W E E N  D1/D3 
This follow-up, between D1 and D3, will be carried out by the PSAD nurse via a home visit or telephone call. 
It will be used to check that the patient has mastered how to use their device (thorough understanding and 
correct use of the "closed-loop" automated insulin delivery system (or "artificial pancreas")). 
Remote technical monitoring takes place throughout the follow-up period. The PSAD nurse views the 
patient’s data on the platform of the “closed-loop” automated insulin delivery system (or “artificial 
pancreas”) to detect any technical problems and checks the technical data is transmitted correctly. 
The interview includes: 
- 
Refresher and/or additional technical training on how to use the "closed loop" automated insulin 
delivery system (or "artificial pancreas") and associated consumables 
- 
A check that the "closed-loop" automated insulin delivery system (or "artificial pancreas") is 
functioning properly 
- 
A check that the patient still has their replacement scheme in case of a system failure and whether 
it has been used 
- 
The collection of any adverse events / SAEs / incidents. If an adverse event is reported, the PSAD 
nurse passes the information on to the investigator for patient assessment and monitoring if 
necessary 
- 
Assessment of the training by the PSAD nurse using the patient acquired knowledge assessment 
questionnaire.  
After this visit, written feedback will be provided to the investigator (prescriber), including an assessment of 
the patient's training and any adverse events. This information will also be recorded in the PSAD service files 
and added to the e-CRF. 
 
VI.6 -  H O M E  V I S I T  F O R  T H E  F I R S T  S E N S O R  C H A N G E  B Y  T H E  PSAD  N U R S E : 
This visit will be made by the PSAD nurse at the patient's home to help the patient change the first glucose 
sensor. This visit takes place at the latest on the last day of use of the sensor. During this visit, the PSAD nurse 

 
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provides refresher training on best practices for using the "closed loop" automated insulin delivery system 
(or "artificial pancreas"). 
 
The interview includes: 
- 
Assistance with changing the glucose sensor for the first time 
- 
Refresher and/or additional technical training on how to use the "closed loop" automated insulin 
delivery system (or "artificial pancreas") and associated consumables 
- 
A check that the "closed-loop" automated insulin delivery system (or "artificial pancreas") is 
functioning properly and being correctly maintained by the patient, according to the user manual 
- 
A check that the patient still has their replacement scheme in case of a system failure and whether 
it has been used 
- 
An evaluation of the consumption of consumables  
- 
The collection of any adverse events / SAEs / incidents. If an adverse event is reported, the PSAD 
nurse passes the information on to the investigator for patient assessment and monitoring if 
necessary 
The PSAD nurse records the interaction in the PSAD files and completes the e-CRF. The PSAD nurse will send 
the investigator a written report and list the adverse events, where applicable. 
VI.7 -  F O L L O W- U P  O N  D30  (D30  ±  15  D A Y S) 
VI.7.1 -  F O L L O W- U P  O N  D30  B Y  T H E  PSAD  N U R S E 
This follow-up, one month after the "closed-loop" automated insulin delivery system (or "artificial pancreas") 
has been installed, will be carried out by the PSAD nurse, by a visit to the patient's home or by a telephone 
call. This interaction is recommended to provide refresher training and assess the patient's acquired 
knowledge (end of initial technical training). 
Remote technical monitoring takes place throughout the follow-up period. The PSAD nurse views the 
patient’s data on the platform of the “closed-loop” automated insulin delivery system (or “artificial 
pancreas”) to detect any technical problems and checks the technical data is transmitted correctly. 
The interview includes: 
- 
Refresher and/or additional technical training on how to use the "closed loop" automated insulin 
delivery system (or "artificial pancreas") and associated consumables 
- 
The patient acquired knowledge assessment questionnaire, completed by the PSAD nurse  
- 
A check that the "closed-loop" automated insulin delivery system (or "artificial pancreas") is 
functioning properly and being correctly maintained by the patient, according to the user manual 
- 
A check that the patient still has their replacement scheme in case of a system failure and whether 
it has been used 
- 
An evaluation of the consumption of consumables  
- 
The collection of any adverse events / SAEs / incidents. If an adverse event is reported, the PSAD 
nurse passes the information on to the investigator for patient assessment and monitoring if 
necessary 
 
At the end of the interview, the PSAD nurse reminds the patient to complete the J30 patient booklet and 
return it in the pre-paid envelope they were given during their hospital stay or hand it to the investigator if 
the 1-month follow-up takes place during a hospital visit. They record this visit in the PSAD files and complete 
the e-CRF. They send a written report to the investigator with their assessment of the patient's training and 
the list of adverse events (where applicable). 

 
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At the end of their interview with the PSAD nurse, the patient completes the D30 patient booklet, which 
consists of the following questionnaires: 
- You and the "closed-loop" automated insulin delivery system (or "artificial pancreas") (Perceived 
benefits) 
- You and your quality of life with diabetes (EQ-5D-5L) 
- You and your beliefs about the medical treatment (BMQ – specific section only) 
- You and your daily constraints 
- You and your management in general (CSQ-8: Overall satisfaction) 
- You and your management by your home healthcare provider (Proactiveness / availability / PSAD 
nurse advice) 
- You and your quality of life and daily constraints linked to the risk of hypoglycaemic episodes (HFS-
II) 
The patient sends the completed D30 patient booklet to the investigator as soon as possible using a pre-paid 
envelope provided to the patient or gives it to the investigator if the 1-month follow-up takes place during a 
hospital visit. Once received, patient questionnaires will be entered in the e-CRF by the investigator or a 
member of the hospital team delegated by the investigator and filed in the patient's source file.  
VI.7.2 -  F O L L O W- U P  O N  D30  B Y  T H E  I N V E S T I G A T O R  
This follow-up can be performed during a hospital visit or by remote consultation at the investigator's 
discretion. The investigator will retrieve data on the patient's metabolic balance over the last 4 weeks from 
the data visualisation platform: 
o Daily average blood sugar level and its variability (standard deviation and coefficient of 
variation, if applicable)  
o Time spent (as a percentage):  
 
In hyperglycaemia (> 180 mg/dl), [180-250 mg/dl] and > 250 mg/dl 
 
In the blood sugar target [70-180 mg/dl] 
 
In hypoglycaemia (< 70 mg/dl), [54-70 mg/dl] and < 54 mg/dl 
o % of time spent in closed loop (if available) 
o The D30 patient booklet, including the following questionnaires if follow-up takes place in 
the hospital: 
 
You and the "closed-loop" automated insulin delivery system (or "artificial 
pancreas") (Perceived benefits) 
 
You and your quality of life with diabetes (EQ-5D-5L) 
 
You and your beliefs about the medical treatment (BMQ – specific section only) 
 
You and your daily constraints 
 
You and your management in general (CSQ-8: Overall satisfaction) 
 
You and your management by your home healthcare provider (Proactiveness / 
availability / PSAD nurse advice) 
 
You and your quality of life and daily constraints linked to the risk of 
hypoglycaemic episodes (HFS-II) 
 
The investigator ensures that the patient meets the criteria for continued use of the system (patient 
follows the technique; sufficient use of the DBLG1™ and t:slim X2™ “closed-loop” systems with Control 
IQ™ technology (minimum use time 75% for semi-closed-loop) and regular observation of results in real-
time) and does not present any discontinuation criteria (choice of the patient and/or their family; poor 
tolerance; use time for the closed-loop system less than 75%; failure to comply with the follow-up 
consultation instructions; misuse of or damage to the equipment). If necessary, use of the system must 
be discontinued and the reasons for the discontinuation given. 

 
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VI.8 -  V I S I T  O N  D90  B Y  T H E  PSAD  N U R S E  (D90  ±  15  D A Y S) 
This visit, three months after the "closed-loop" automated insulin delivery system (or "artificial pancreas") is 
installed, will be carried out by the PSAD nurse at the patient's home. It should be used to assess the patient's 
knowledge (continuous technical training and reminder of the initial technical training) and confirm their best 
practices. This visit should be carried out before the patient's end-of-study visit at the centre. 
Remote technical monitoring takes place throughout the follow-up period. The PSAD nurse views the 
patient’s data on the platform of the “closed-loop” automated insulin delivery system (or “artificial 
pancreas”) to detect any technical problems and checks the technical data is transmitted correctly. 
The interview includes: 
- 
An assessment of the patient’s knowledge at both the beginning and end of the training and the 
patient acquired knowledge assessment questionnaire, completed by the PSAD nurse in the e-CRF. 
- 
A point-by-point review of the initial technical training by having the patient repeat the necessary 
operations. 
- 
A reminder of the safety rules. 
- 
A review of anything that has not been understood. 
- 
A check of the terminal, including its proper maintenance and the patient’s correct understanding of 
how it works. 
- 
A check of the pump and its proper maintenance. 
- 
A check of the interstitial glucose measurement system and its proper maintenance. 
- 
Verification that the patient still has their replacement scheme and whether it has been made use 
of, as well as the expiration dates for the insulin, pen and emergency kit. 
- 
An evaluation of the consumption of consumables  
- 
The collection of any adverse events / SAEs / incidents. If an adverse event is reported, the PSAD 
nurse passes the information on to the investigator for patient assessment and monitoring if 
necessary 
- 
Collection of partially used and unused boxes by the PSAD nurse. However, used boxes are not 
collected. 
At the end of the interview, the PSAD nurse records this visit in the PSAD files and completes the e-CRF. The 
PSAD nurse sends the investigator a written report with an assessment of the patient's training and a list of 
adverse events (where applicable). 
After the last follow-up of the last patient included on D90 in the hospital centre, the PSAD nurse completes 
the PSAD Satisfaction Questionnaire in the e-CRF. 
VI.9 -  E N D- O F- S T U D Y  V I S I T 
The end-of-study visit is carried out approximately 3 months (± 15 days) after the "closed loop" automated 
insulin delivery system (or "artificial pancreas") is installed. An end-of-study visit will be carried out for all 
patients. If the patient ends their participation in the study before its scheduled end, the patient's condition, 
date and the reason for termination will be documented in the patient's medical file and reported in the e-
CRF. 
 
For this end-of-study or early discharge visit, the patient will attend the hospital and undergo the following 
procedures (if possible): 
- 
HbA1c blood test 

 
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- 
Metabolic balance over the last 4 weeks: 
- 
Daily average blood sugar level and its variability (standard deviation and coefficient of 
variation, if applicable)  
- 
Time spent (as a percentage):  
- 
In hyperglycaemia (> 180 mg/dl), [180-250 mg/dl] and > 250 mg/dl 
- 
In the blood sugar target [70-180 mg/dl] 
- 
In hypoglycaemia (< 70 mg/dl), [54-70 mg/dl] and < 54 mg/dl 
- 
% of time spent in closed loop (if available) 
- 
D90 patient booklet including the following questionnaires: 
° 
You and the "closed-loop" automated insulin delivery system (or "artificial pancreas") 
° 
You and your quality of life with diabetes (EQ-5D-5L) 
° 
You and your beliefs about the medical treatment (BMQ – specific section only) 
° 
You and your health (Patient profile / state of health) 
° 
You and your daily constraints 
° 
You and your management in general (CSQ-8: Overall satisfaction) 
° 
You and your management by your home healthcare provider (Proactiveness / availability / 
PSAD nurse advice) 
° 
You and your quality of life and daily constraints linked to the risk of hypoglycaemic episodes 
(HFS-II) 
- 
Collection of any adverse events / SAEs / incidents 
At this visit, as well as at the 1-month visit, the investigator will assess the continued use of the system, which 
will apply both to patients followed up after 3 months in accordance with the protocol and to those 
discharged prematurely. This assessment will be based on the above-mentioned criteria plus a clinical 
evaluation of the objectives set in advance (severe hypoglycaemia, diabetes ketoacidosis, time spent above 
or below the set threshold values) and/or a biological (HbA1c) evaluation. 
The data, including the date and reason for discharge from the study (see section IV.3 in the event of early 
termination), are written down in the patient's source file and recorded in the e-CRF by the investigator or a 
member of the hospital team delegated by the investigator. 
Furthermore, after the last end-of-study visit of the last patient included in the hospital centre, each 
investigator who participated in fitting at least one patient in the study completes the investigator 
Satisfaction Questionnaire in the e-CRF.  
 

 
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VI.10 -  A S S E S S M E N T S  A N D  P R O C E D U R E S 
VI.10.1 -  G E N E R A L  A S S E S S M E N T  
Patient demographics, medical history and clinical characteristics 
The following data are collected at inclusion and reported in the e-CRF: 
- 
Demographic data: age, weight, height, gender and, for women, fertility and contraceptive method. 
- 
The diabetes history including the date of first diagnosis, and any micro- and macro-vascular 
complications associated with diabetes.  
- 
Metabolic balance (see section VI.10.9).  
- 
Other relevant history and comorbidities. 
Socio-professional data 
Socio-professional data: level of education, socio-professional category, urban unit bracket and lifestyle, are 
recorded in the e-CRF at inclusion. 
Diabetes management 
The date the patient was first put on the pump and their daily U-100 rapid-acting insulin requirements 
(NovoRapid® or Humalog®) are recorded in the e-CRF at inclusion. The investigator also records in the e-CRF 
whether the patient has already been fitted with a "closed loop" automated insulin delivery system (or 
"artificial pancreas") and whether their inclusion in the study leads to a change in home healthcare provider.  
Pregnancy test 
At inclusion, a urinary pregnancy test is performed in women of childbearing age.  
VI.10.2 -  L A B O R A T O R Y  W O R K - U P 
Creatinine / Creatinine Clearance 
If a creatinine measurement and creatinine clearance calculation performed less than 6 months ago are not 
available in the patient's medical file at inclusion, the creatinine blood test must be carried out and clearance 
calculated at inclusion to confirm the patient's participation in the study. 
HbA1c 
An HbA1c blood test is carried out at inclusion if an HbA1c measurement (performed in a medical analysis 
laboratory or equivalent) less than 4 months old is not available in the patient's medical file. In this case, the 
value of the assay at inclusion will be used as a reference at installation. 
If an HbA1c measurement (performed in a medical analysis laboratory or equivalent) less than 4 months old 
is available in the patient's medical file, the HbA1c blood test is performed at installation. 
The HbA1c blood test is also performed at the end of the study. 
 
 

 
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VI.10.3 -  H O M E  H E A L T H C A R E  P R O V I D E R  (PSAD)  M A N A G E M E N T 
The activities of the PSADs in this study are consistent with their normal practices. The only difference in 
terms of everyday practice is having to complete questionnaires specific to the study. 
During each interaction set out in the Protocol, the following information is recorded: 
- 
Type of interaction: visits / telephone calls 
- 
Study phases: pre-installation, installation, follow-up 
For visits: 
 Location: home / hospital 
- 
Date of interaction 
- 
Time spent: start time and end time  
- 
The usefulness and necessity of the interaction to the patient; if none, please specify in what way 
- 
New visit to be scheduled 
- 
Adverse event where applicable 
- 
Written report to the prescriber 
 
Depending on whether the interaction is for pre-installation, installation or follow-up, the following 
information may be requested:  
- 
Primary and secondary reasons for the interaction: 
 Training / need for additional training 
 Motivational support or need to be reassured 
 Information on the patient's lifestyle (holidays, going abroad, etc.) 
 Medical situation requiring contact with the doctor / other 
 Support installing the sensor 
 Other 
Any interaction not set out in the Protocol is also recorded in the e-CRF. In addition to the above, the 
following information is collected:  
- 
Person who initiated the interaction (patient, investigator, PSAD or other) 
- 
In addition to the above-mentioned reasons:  
 Fault, and if so, the type and nature of the fault 
 Difficulty assessing/reporting an event (meals, physical activity, etc.) 
 Failure to understand one of the algorithm's proposals 
 Alarm or alert management 
 Replenishment needs (ordering pumps, sensors, etc.) 
 Other  
- 
Additional information on the nature and reason for the call, namely:  
 Problem resolved after the interaction 
 Home intervention required, and if so, for which actions and for what reason 
 Medical device vigilance case identified 
 Information on the patient's use of the system (management, replacement scheme, closed loop, 
etc.) 
In the follow-up phase, during each home visit the PSAD nurse checks: 
- 
That the "closed-loop" automated insulin delivery system (or "artificial pancreas") is functioning 
properly and being correctly maintained by the patient 
- 
The patients' adherence, by asking about their use of the system and through their consumption of 
the consumables (keeping an inventory of boxes (MDs and consumables) provided, unused or 
partially used, see section V.2.4). 
 
 

 
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VI.10.4 -  D E S C R I P T I O N  O F  T H E  S T U D Y  Q U E S T I O N N A I R E S  
In addition to the patient acquired knowledge assessment questionnaire used in the PSADs' day-to-day 
practice, 11 study-specific questionnaires will be used: 9 patient questionnaires, 1 investigator questionnaire 
and 1 PSAD questionnaire.  
VI.10.5 -  P A T I E N T  Q U E S T I O N N A I R E S 
Each questionnaire completed by the patient will be recorded in the e-CRF by a hospital centre member 
delegated by the investigator. 
You and the "closed-loop" automated insulin delivery system (or "artificial pancreas") (Expected benefits 
/ Perceived benefits) 
This is an ad-hoc questionnaire developed by the FFD, entitled "You and the "closed-loop" automated insulin 
delivery system (or "artificial pancreas")". It measures the difference between the patient's expectations and 
their experience with the MD and how the PSAD helped reduce this discrepancy during follow-up; it describes 
the impact of management on the patient's autonomy (ability to use the MD independently and to increase 
their competence) and on the reduction of their mental load. 
It is composed of: 
- 
11 questions with two possible answers: 
o During the first assessment, the patient assesses the expected benefits of the "closed-loop" 
automated insulin delivery system (or "artificial pancreas"), and the possible answers are: 
"Yes, I hope so " or "I don't have any expectations regarding this matter".  
o In the subsequent assessments, the patient assesses the perceived benefits of the "closed-
loop" automated insulin delivery system (or "artificial pancreas"), and the possible answers 
are: "Yes, I have noticed this" or "I have not noticed anything regarding this matter ". 
- 
1 scale from 1 (no confidence at all) to 10 (complete confidence) concerning the level of confidence 
in the technical use of the "closed loop" automated insulin delivery system (or "artificial pancreas"). 
There is no specific score, the answers are evaluated independently of each other. 
 
You and your quality of life with diabetes (EQ-5D-5L) 
The patient's quality of life is assessed by the EQ-5D-5L questionnaire (24) (25) (26). This is a validated French-
language questionnaire that measures the patient's quality of life in the context of using a "closed-loop" 
automated insulin delivery system (or "artificial pancreas"), in terms of the impact on their activities 
(mobility, autonomy, daily activities, pain/discomfort, anxiety/depression), and is used to describe the effect 
PSAD management has on this quality of life during follow-up. It is composed of: 
- 
5 items each corresponding to a specific dimension (mobility, self-care, usual activities, 
pain/discomfort and anxiety/depression) and divided into 5 levels of perception (1. no problem, 2. 
slight problems, 3. moderate problems, 4. severe problems, 5. extreme problems/incapacity). 
- 
1 scale from 0 (worse health than the patient can imagine) to 100 (best health than the patient can 
imagine) representing the patient's state of health on the day the questionnaire is completed.  
The patient reports their state by ticking the number on the scale, giving a value between 0 and 100. 
 
 

 
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You and your quality of life and daily constraints linked to hypoglycaemia (HFS-II)  
The original “Hypoglycaemia Fear Survey (HFS)” was developed to assess hypoglycaemia-related behaviours 
and concerns in adults with type 1 and type 2 diabetes (30). The original version of the HFS (HFS-I) and the 
revised version (HFS-II) are composed of 33 items divided into two sub-categories: Behaviour (HFS-B) and 
Worry (HFS-W):  
● HFS-B: 15 questions that outline behaviours patients may adopt to avoid hypoglycaemic episodes 
and/or their negative consequences (keeping blood glucose above 150 mg/dl, ensuring other people 
are present and limiting physical activity). 
● HFS-W: 18 questions that outline specific concerns patients may have about their hypoglycaemic 
episodes (being alone, having episodes while sleeping or having an accident).  
The questionnaire uses a Likert scale with 5 response options ranging from “never” to “always”. The scores 
are then aggregated to obtain scores from the two sub-categories and the total score. 
The HFS-II is a valid and reliable questionnaire (31) for assessing the fear of hypoglycaemia. It has been 
validated for use in many languages and countries, including France. 
 
You and your beliefs about the medical treatment (BMQ – specific section only) 
The patient's beliefs about the medical treatment is assessed by the specific section of the BMQ (Beliefs 
about Medicines Questionnaire), validated in French for diabetes (27), which describes the patient's 
perception of the MD in a wider sense; it is used to describe the effect PSAD management has on the patient's 
perception of the MD during the follow-up. 
The specific BMQ consists of two parts:  
- 
Part one contains five questions related to the need for the treatment.  
- 
Part two contains five questions on concerns about the prescription. 
The 10 questions are answered using a 5-point scale (: 1. strongly disagree, 2. disagree, 3. uncertain, 4. agree 
and 5. strongly agree. 
The results of the specific BMQ therefore take the form of two scores ranging from 5 to 25.  
 
You and medical devices (Patient profile / MD experience) 
The patient's profile in terms of their experience with medical devices is assessed by an ad-hoc questionnaire 
entitled: "You and medical devices", developed by the FFD. It is used to contextualise the satisfaction score 
obtained for PSAD management, based on the patient's actual experience of "medical devices" (history of 
use and level of competence with "connected medical devices") over the course of the follow-up. 
It consists of 5 questions including: 
- 
2 scales from 1 (no confidence at all) to 10 (complete confidence) 
- 
3 multiple-choice questions. 
There is no specific score, the answers are evaluated independently of one another. 
 
 
 
You and your health (Patient profile / state of health) 
The patient's feelings about their current and future state of health are assessed by an ad-hoc questionnaire 
entitled: "You and your health", developed by the FFD. It is used to contextualise the satisfaction score 

 
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obtained for PSAD management, based on the patient's portrayal of their current and future state of health 
over the course of the follow-up. 
It consists of 2 questions: 
- 
One on the current state of health with 5 possible answers: excellent, very good, good, poor, very 
poor 
- 
The other looking ahead at the diabetic patient's future, with 4 possible answers: with great 
confidence, with confidence, with concern, with great concern. 
There is no specific score, the answers are evaluated independently of each other. 
 
You and your daily constraints 
The patient's everyday constraints are assessed based on the past month, with a question proposed by the 
FFD in the form of a pre-established multiple-choice list. This question is used to measure the patient's quality 
of life in the context of using a "closed-loop" automated insulin delivery system (or "artificial pancreas"), by 
describing the effect the PSAD's management has on how the patient perceives the constraints caused by 
their disease throughout the follow-up. 
The list includes the following 12 items: 
- 
Managing other people's perceptions of my diabetes 
- 
Anticipating my activities 
- 
Thinking about my diabetes all the time 
- 
Dealing with my diabetes all the time 
- 
Fear of experiencing hypoglycaemia 
- 
Fear of experiencing hyperglycaemia 
- 
Uncertainties about my future health 
- 
Carrying one or more treatment devices on me at all times 
- 
Handling my continuous glucose sensor 
- 
Handling all my treatment equipment (pump, glucose sensor, etc.) 
- 
Determining my insulin doses several times a day 
- 
Hearing the audible alarms of my treatment equipment (pump, glucose sensor, etc.) 
There is no specific score, the answers are evaluated independently of one another. 
 
You and your management in general (CSQ-8: Overall satisfaction) 
The patient's overall satisfaction with their management is assessed by the CSQ-8 (Client Satisfaction 
Questionnaire) (28) (29). This is a validated French-language questionnaire, which consists of 8 questions. It 
measures the patient's direct satisfaction with specific services provided and received within a given time 
frame and specific service framework. It is used to describe the effect of PSAD management on this overall 
patient satisfaction during the follow-up. Each question is answered using a 4-point scale (e.g. 1. poor, 2. 
average, 3. good, 4. excellent). 
The score ranges from 8 to 32, with higher values indicating higher satisfaction22, 23. 
 
 
You and your management by your home healthcare provider (Proactiveness / availability / PSAD advice) 
The patient's targeted experience / satisfaction is assessed by an ad-hoc questionnaire entitled: "You and 
your management by your home healthcare provider" developed by the French Diabetes Federation (FFD). 

 
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The questionnaire assesses the proactiveness, availability and PSAD nurse advice. It is used to measure 
patients' overall satisfaction with their management by the PSAD during the follow-up. 
It is composed of: 
- 
13 questions answered using a 5-point scale 
- 
3 scales from 1 (no confidence at all) to 10 (complete confidence). 
There is no specific score, the answers are evaluated independently of each other. 
 
VI.10.6 -  P A T I E N T  
A C Q U I R E D  
K N O W L E D G E  
A S S E S S M E N T  
Q U E S T I O N N A I R E 
The knowledge acquired by the patient is assessed via an ad-hoc questionnaire, developed by the sponsor. 
The questionnaire is completed by the PSAD nurse and each item is recorded in the e-CRF. 
The questionnaire is divided into 2 parts:  
- 
Learning the basic functions 
- 
Learning the advanced open-loop functions/settings. 
Part one contains 12 sections, each evaluating between 4 and 12 items. The 12 sections relate to knowledge 
on: 
- 
Precautions for use of the components 
- 
Data visualization software  
- 
Initialisation of the control module/terminal 
- 
Reading the control module/terminal screen 
- 
Control module/terminal menu 
- 
Remote-control mode 
- 
Use of the pump 
- 
Cartridge 
- 
Catheter 
- 
Sensor  
- 
Alarms/Alerts/Information 
- 
Various knowledge (on-call support, procedure to follow, etc.). 
Part two contains 4 sections, each assessing between 1 and 4 items. The 4 sections relate to the following: 
- 
Advanced settings 
- 
Use of reminder alarms 
- 
Programming specific boluses 
- 
Functional insulin therapy. 
Each item is evaluated as: not addressed, not acquired, in progress, acquired. 
 
 
VI.10.7 -  I N V E S T I G A T O R  S A T I S F A C T I O N  Q U E S T I O N N A I R E 
The investigators' satisfaction is assessed via an ad-hoc questionnaire, developed by the sponsor. Each 
investigator who participated in fitting at least one patient in the study completes the questionnaire once 
only, after the last patient in the study has left the centre, in order to obtain their overall satisfaction with all 
of their included patients rather than their satisfaction with each patient. 

 
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The questionnaire is divided into 5 parts: 
- 
General questions about the study and the "closed-loop" automated insulin delivery system (or 
"artificial pancreas") 
- 
Assessment of the follow-up conducted by the PSAD nurse during the initial period, i.e. before the 
patient returns home 
- 
Assessment of the follow-up conducted by the PSAD nurse after the patient returns home 
- 
Overall satisfaction 
- 
Access to data and use of the data visualisation platform. 
The answers are evaluated independently of one another; no score is provided for this questionnaire. Each 
item will be completed directly in the e-CRF. 
 
 

 
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VI.10.8 -  PSAD  S A T I S F A C T I O N  Q U E S T I O N N A I R E 
The satisfaction of the PSAD nurses is assessed by an ad-hoc questionnaire, developed by the sponsor. Each 
PSAD nurse completes the questionnaire once only after the D90 of their last patient, in order to obtain their 
overall satisfaction with all of their included patients rather than their satisfaction with each patient. 
The questionnaire is divided into 7 parts: 
- 
Training received on the "closed-loop" automated insulin delivery system (or "artificial pancreas") 
- 
Equipment (logistical aspects) 
- 
Quality of the products 
- 
Use of the system 
- 
Services provided by the PSAD nurse (relevance of the follow-up Protocol proposed to the patient) 
- 
Reception of the system by the patient 
- 
Relations with the hospital service. 
The answers are evaluated independently of one another; no score is provided for this questionnaire.  
Each item will be recorded in the e-CRF. 
 
VI.10.9 -  M E T A B O L I C  B A L A N C E  
The patient's clinical course is assessed on the basis of their metabolic balance at inclusion, on D30 and at 
the end of the study (D90) and described by the following values: 
- 
HbA1c (see section VI.10.2; not collected on D30) 
- 
Metabolic balance over the last 4 weeks: 
o Daily average blood sugar level and its variability (standard deviation and coefficient of 
variation, if applicable)  
o Time spent (as a percentage):  
 
In hyperglycaemia (> 180 mg/dl), [180-250 mg/dl] and > 250 mg/dl 
 
In the blood sugar target [70-180 mg/dl] 
 
In hypoglycaemia (< 70 mg/dl), [54-70 mg/dl] and < 54 mg/dl 
o % of time spent in closed loop (if available) 
These values are available via the data visualisation platform, provided the patient gives the investigator 
access to this platform. 
VI.10.10 -  S A F E T Y  A S S E S S M E N T  
Safety assessments consist of recording all adverse events, serious or non-serious, related or unrelated to 
the "closed-loop" automated insulin delivery system (or "artificial pancreas"), expected or unexpected, 
occurring from the time signed consent is obtained until the end of the study for the patient. 
Adverse events may be spontaneously reported by the patient or may come to light following a discussion 
with hospital staff. The occurrence and follow-up of adverse events and, if applicable, pregnancy should be 
assessed at each visit. 
All of these adverse events are documented in the patient's source file and then recorded in the e-CRF, in 
accordance with section VIII. 
In addition, the following parameters are incorporated into the assessment of the safety profile for patients 
fitted with a "closed-loop" automated insulin delivery system (or "artificial pancreas"): 
- 
Episodes of severe hypoglycaemia requiring the intervention of a third party for glucose 
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- 
Episodes of hyperglycaemia with ketosis. 
- 
All incidents related to the "closed-loop" automated insulin delivery system (or "artificial 
pancreas"). 
These parameters are documented in the patient's source file and reported in the e-CRF, after discussion 
with the patient and connection to the data visualisation platform. 
 
VI.10.11 -  E X P L O R A T O R Y  
A S S E S S M E N T S  
A N D  
P R O C E D U R E S  
–  
E C O N O M I C  A S S E S S M E N T  O F  T H E  S E R V I C E  I N  V O L U M E  A N D  
C O S T S 
The description of the economic indicators of the service takes into account:  
o Generally speaking, the costs are not recorded directly, but are calculated based on the number 
of visits and/or calls made by the PSAD to deliver the service in the various scenarios mentioned 
(see secondary criteria "PSAD management"). The flat rate per intervention type (visit or 
telephone) in the pricing grid provided by the sponsor will be used to estimate the costs. The 
total cost includes the cost of the PSAD in the hospital, at the patient's home and remotely.  
o For each PSAD intervention (in person or by telephone), the PSAD's time and number of 
interventions are recorded. To assess the cost of this time, the PSAD will communicate an hourly 
rate. 
o The PSAD also communicates the cost of the "closed-loop" automated insulin delivery system 
(or "artificial pancreas"). 
o The consumption of consumables (such as pump consumables, glucose sensors, transmitter, 
etc.) is described on the basis of interactions with the PSAD and the amount of consumables 
actually used by the patient. Consumption is compared with a theoretical consumption based 
on the service life of the consumables for the study period. The costs associated with this 
consumption are calculated using the pricing grid provided by the sponsor 
 
The description of the quality indicators of the service takes the following into account: 
o Percentage of patients with training validated on D1/D3, D30 and D90  
o Number of calls/patient broken down by call type (technical, medical, etc.): : 
 
With training validated on D1/D3, D30, D90 
 
Without training validated on D1/D3, D30, D90 
o Medical prescription decision-making aid: percentage of patients not eligible for the "closed-
loop" automated insulin delivery system (or "artificial pancreas") following a pre-installation 
visit (assessment of the patient's motivation and ability to use the "closed-loop" automated 
insulin delivery system (or "artificial pancreas")) 
o Percentage of visits following a technical incident call 
o Time and frequency of use of the data platform for each “closed-loop" system. 
Each quality indicator for PSAD service delivery will be described. 
VII -  EVALUATION CRITERIA 
VII.1 -  P R I M A R Y  C R I T E R I O N  

 
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The primary assessment criterion concerns patient satisfaction and experience, which are assessed by 
questionnaires on D30 and D90. 
The CSQ-8 questionnaire assesses patients' overall satisfaction with their management in general. 
Satisfaction is confirmed by a score above 20 points (on a scale of 8 to 32) on D30. Maintenance of satisfaction 
is measured on D90 by a score above 20 points which has not decreased by more than 4 points compared 
with D30. 
The targeted experience / satisfaction is assessed with the questionnaire "You and your management by 
your home healthcare provider" (Proactiveness / availability / PSAD advice). The percentage of patients in 
each category and the scale scores are assessed independently.  
VII.2 -  S E C O N D A R Y  C R I T E R I A  
The secondary assessment criteria are described below: 
Home healthcare provider (PSAD) management 
 
PSAD management is described during the different phases (pre-installation, installation, follow-up) 
by:  
o The number of interactions.  
o Their type (visits / telephone calls).  
o The time spent.  
o The reason for these interactions and, for the visits, by their location (home / hospital).  
The reason for an interaction is selected from:  
 
Training  
 
Motivational support or need for reassurance  
 
Malfunction  
 
Difficulty assessing / reporting an event (meal, physical activity, etc.)  
 
Failure to understand one of the algorithm's proposals  
 
Alarm or alert management  
 
Replenishment needs (ordering pumps, sensors, etc.) 
 
Information on the patient's lifestyle  
 
Medical situation requiring contact with the doctor  
 
Other. 
 
The management observed is also described for all the “closed-loop” systems used in the study 
according to whether or not these interactions were set out in the opinion of the HAS (French 
National Authority for Health) dated 28 January 2020 for the Diabeloop DBLG1TM system, and is 
therefore compared with the management initially scheduled for conducting the study (number of 
visits or telephone calls made versus those scheduled).  
 
The knowledge acquired by the patient during their initial training is evaluated by the PSAD nurse 
using the acquired knowledge assessment questionnaire on D1/D3, D30 and D90.  
 
The satisfaction of the PSAD nurses is assessed with the PSAD satisfaction questionnaire. This 
questionnaire is completed once by each PSAD nurse at the end of the study (after the D90 of the 
last patient at the centre). It takes into account the PSAD nurse's opinion on all of the services they 
provide. For each question, the response rate for each category is described. 
Patient questionnaire 
 
The patient's profile in terms of their experience with medical devices is assessed by the "You and 
medical devices" questionnaire completed at the time of inclusion. For each question, the response 
rate for each category is described. 

 
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 
The patient's feelings about their current and future state of health are assessed by the "You and 
your health" questionnaire completed at inclusion and on D90. For each question, the response rate 
for each category is described.  
 
The patient's quality of life is assessed by the EQ5D-5L questionnaire, at inclusion, on D30 and D90.  
 
Quality of life and daily constraints related to the risk of hypoglycaemic episodes are assessed by the 
HFS-II questionnaire at inclusion, on D30 and D90. 
 
The daily constraints encountered by the patient are assessed based on the past month with the 
question "You and your daily constraints", at inclusion, on D30 and D90. For each item, the 
percentage of patients is estimated. In addition, the number of items ticked per patient is also 
assessed to estimate a level of constraints for each patient. 
 
The expected and perceived benefits of the "closed-loop" automated insulin delivery system (or 
"artificial pancreas") are assessed by the questionnaire "You and the "closed-loop" automated insulin 
delivery system (or "artificial pancreas")", completed at inclusion, on D30 and D90. The percentage of 
patients who have expected and perceived benefits is described for each item on the whole. 
 
The patient's beliefs related to the medical treatment is assessed by the specific section of the BMQ 
(Beliefs about Medicines Questionnaire) questionnaire, at inclusion, on D30 and D90. The scores 
related to the need for treatment and prescription concerns are described, as well as the difference 
between need and concern. 
Investigator satisfaction questionnaire 
This questionnaire is completed once by each investigator at the end of the study (after the last patient 
has left the centre). It takes into account the investigator's opinion on all of their included patients. 
For each question, the response rate for each category is described. 
Safety 
The safety profile of patients with a "closed-loop" automated insulin delivery system (or "artificial pancreas") 
is described according to:  
 
All serious adverse events (SAEs) and non-serious adverse events, both related and unrelated to the 
"closed-loop" automated insulin delivery system (or "artificial pancreas"), whether expected or 
unexpected, including: 
o Episodes of severe hypoglycaemia requiring the intervention of a third party for glucose 
administration. 
o Episodes of hyperglycaemia with ketosis. 
 
All incidents related to the "closed-loop" automated insulin delivery system (or "artificial pancreas"). 
 
 
 
Clinical course 
The patient's clinical profile and its evolution are described by the values of: 
 
HbA1c, measured at the time of installation and on D90. 
 
Daily average blood sugar level and its variability (standard deviation and coefficient of variation, if 
applicable) at inclusion, on D30 and D90. 

 
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 
Percentage of time spent over a 4-week period: in the blood sugar target [70-180 mg/dl], in 
hypoglycaemia (< 70 mg/dl, [54-70 mg/dl] and < 54 mg/dl)  and in hyperglycaemia (> 180 mg/dl, [180-
250 mg/dl] and > 250 mg/dl) at inclusion, on D30 and D90.  
 
Percentage of time spent using a closed-loop system over a 4-week period, if available, on D30 and D90. 
VII.3 -  E X P L O R A T O R Y  C R I T E R I A  
The exploratory assessment criteria are described below: 
Economic assessment of the service, in volume and costs  
 
Description of the economic indicators of the service:  
o 
Generally speaking, the costs will not be recorded directly, but will be calculated based on the 
number of visits and/or calls made by the PSAD nurse to deliver the service in the various scenarios 
mentioned (see secondary criteria "PSAD management"). The flat rate per intervention type (visit 
or telephone) in the pricing grid provided by the sponsor will be used to estimate the costs. The 
total cost includes the cost of the PSAD nurse in the hospital, at the patient's home and remotely.  
o 
The PSAD also communicates the cost of the "closed-loop" automated insulin delivery system (or 
"artificial pancreas"). 
o 
The consumption of consumables (such as pump consumables, glucose sensors, transmitter, etc.) 
is described on the basis of interactions with the PSAD and the amount of consumables actually 
used by the patient. Consumption is compared with a theoretical consumption based on the service 
life of the consumables for the study period. The costs associated with this consumption are 
calculated using the pricing grid provided by the sponsor 
 
Description of the quality indicators of the service: 
o 
Percentage of patients with training validated on D1/D3, D30 and D90  
o 
Percentage of patients with training validated on D1/D3, D30 and D90 according to socio-
professional data 
o 
Number of calls/patient broken down by call type (technical, medical, etc.): 
 With training validated on D1/D3, D30, D90 
 Without training validated on D1/D3, D30, D90 
o 
Medical prescription decision-making aid: percentage of patients not eligible for the "closed-
loop" automated insulin delivery system (or "artificial pancreas") following a pre-installation visit 
(assessment of the patient's motivation and ability to use the "closed-loop" automated insulin 
delivery system (or "artificial pancreas")) 
o 
Percentage of visits following a technical incident call  
o 
Time and frequency of use of the data platform for each “closed-loop" system. 
Each quality indicator for PSAD service delivery will be described. 
 
Sub-group assessment 
The results will be described for all patients and for the sub-group of patients who have already used the 
"closed-loop" automated insulin delivery system (or "artificial pancreas") or an earlier version used in 
previous clinical trials, versus patients who were device-naive prior to inclusion in the study. 

 
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VIII -  VIGILANCE 
VIII.1 -  D E F I N I T I O N S 
VIII.1.1 -  A D V E R S E  E V E N T   
An adverse event is any untoward event that occurs in an individual participating in research involving human 
subjects, whether or not the event is connected to the research or the product to which the research relates. 
VIII.1.2 -  A D V E R S E  D E V I C E  E F F E C T 
An adverse device effect (ADE) refers to any untoward and unintended reaction to a medical device or any 
incident that could have caused such a reaction if appropriate action had not been taken, in an individual 
participating in research or in the user of the medical device, or any effect related to a malfunction of or 
damage to a medical device and harmful to the health of a person participating in research. 
VIII.1.3 -  U N E X P E C T E D  A D V E R S E  E F F E C T 
An unexpected adverse effect is defined as any adverse effect of the medical device whose nature, severity, 
or development is not consistent with the information available in the applicable version of the medical 
device's safety reference document. 
The safety reference document for the "closed loop" automated insulin delivery system (or "artificial 
pancreas") is the current version of this system's user manual. 
VIII.1.4 -  I N C I D E N T 
An incident is due to an accident or error, which may lead to an adverse effect in the patient. 
VIII.2 -  C L A S S I F I C A T I O N 
VIII.2.1 -  I N T E N S I T Y 
The intensity of the adverse events will be assessed by the investigator as follows: 
- 
Mild: The event causes discomfort without disrupting normal daily activities.  
- 
Moderate: The event causes discomfort that disrupts normal daily activities. 
- 
Severe: The event prevents the patient from carrying out their normal daily activities or significantly 
affects their clinical condition. 
 
 

 
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VIII.2.2 -  C A U S A L I T Y 
For each adverse event, the investigator should assess whether or not they consider the event to be related 
to the "closed-loop" automated insulin delivery system (or "artificial pancreas"). 
Assessment of causality according to five levels: 
The causal link between the adverse event and the medical device will be classified according to the 5 levels 
below: 
- 
Unrelated: an adverse event whose link to the use of the investigational medical device has been 
ruled out definitively. 
- 
Unlikely: an adverse event that, after careful examination at the time of the assessment, is 
considered to be due to external causes (such as disease, environment, treatments, etc.) and does 
not meet the causality criteria of "Possible", "Probable" and "Definite causal relationship" (listed 
below) with the investigational medical device. 
- 
Possible: an adverse event whose link to the use of the investigational medical device cannot be ruled 
out after careful examination at the time of assessment. 
- 
Probable: an adverse event whose link to the use of the investigational medical device appears with 
a high degree of certainty, after careful examination at the time of assessment. 
- 
Definite causal relationship: an adverse event that has been proven without a doubt to be entirely 
linked to the use of the investigational medical device, after careful examination at the time of 
assessment. 
If a "Possible" or "Probable" causal link or "Definite causal relationship" is suggested, the adverse event 
corresponds to the definition of an adverse device effect (ADE). 
VIII.2.3 -  S E V E R I T Y 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is defined as an adverse event that meets one or more of the following criteria:  
- 
Fatal (results in death; note that death is a development and not an event). 
- 
Is life-threatening (Note: a life-threatening event refers to an event for which the patient was in 
danger of death at the time the event occurred; it does not refer to an event that could have led to 
death if it had been more serious). 
- 
Requires hospitalisation or prolongation of hospitalisation. 
- 
Causes significant or lasting incapacity or disability. 
- 
Results in a congenital anomaly or defect. 
- 
Is a medically significant event (if the event does not meet any of the above criteria). 
 
 

 
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Unanticipated Serious Adverse Device Effect  
A suspected unanticipated serious adverse device effect (USADE: is an adverse event that is considered to be 
related to the "closed loop" automated insulin delivery system (or "artificial pancreas") and is considered 
both serious and unanticipated (see above-mentioned medical device safety reference document). 
VIII.3 -  R E C O R D I N G  A N D  D E C L A R I N G  A D V E R S E  E V E N T S  A N D  I N C I D E N T S 
VIII.3.1 -  R E G I S T E R I N G  A D V E R S E  E V E N T S   
All adverse events (related or unrelated to the "closed loop" automated insulin delivery system (or "artificial 
pancreas"), expected or unexpected) that occur during the study, from the time signed informed consent is 
obtained until the end of the study for the patient (final assessment carried out as part of the study), will be 
noted in the patient's source file and recorded in the e-CRF by the investigator. If an adverse event is recorded 
by the PSAD nurse during an interaction (visit or telephone contact) with the patient, the PSAD nurse 
transmits the information to the investigator in a written report. 
The following information will be recorded: the nature of the event (sign, symptom or preferably a diagnosis), 
intensity, date of occurrence, development (with date resolved if applicable), severity, causal link to the 
"closed loop" automated insulin delivery system (or "artificial pancreas"), corrective medical treatment and 
action taken with respect to the "closed loop" automated insulin delivery system (or "artificial pancreas"). 
Should an adverse event occur during a study visit, it will be monitored during subsequent visits.  
Any adverse events considered as possibly related to the "closed loop" automated insulin delivery system (or 
"artificial pancreas") will be monitored until it is resolved or stabilised.  
 
VIII.3.2 -  R E C O R D I N G  I N C I D E N T S 
Should an incident with the "closed-loop" automated insulin delivery system (or "artificial pancreas") occur, 
it will be recorded in the PSAD file and reported in a specific e-CRF form by the PSAD. If the investigator 
identifies any MD incidents, they will report them to the PSAD within 24 hours of learning about the event. 
The PSAD also informs the supplier of any incident with the "closed loop" automated insulin delivery system 
(or "artificial pancreas"). 
 
 

 
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VIII.3.3 -  D E C L A R A T I O N  O F  S E R I O U S  A D V E R S E  E V E N T S 
Initial Declaration 
All serious adverse events (related or unrelated to the "closed loop" automated insulin delivery system (or 
"artificial pancreas"), expected or unexpected) occurring during the study, from the time signed informed 
consent is obtained until the end of the study for the patient (final assessment carried out as part of the 
study), will be declared by the investigator in the e-CRF within 24 hours of being informed about the event.   
If a causal link with the MD is established, an automatic notification is sent to the PSAD service and the 
sponsor.  
If the PSAD service is the first to be informed of an SAE, it will immediately inform the investigator. 
Following notification of an SAE, the PSAD service may request additional data relating to this SAE from the 
investigator, who must respond to these requests for additional information as soon as possible. 
All SAEs must be documented in the patient's file (hospital and PSAD). 
The PSAD service will be responsible for making the medical device vigilance declaration to the ANSM, as is 
standard practice. 
Some events will not be considered SAEs. This includes the following cases: 
- Hospitalisation for elective surgery or a procedure/treatment that was scheduled prior to inclusion 
in the study for a pre-existing condition/disease which has not worsened since the beginning of the 
study. 
- Hospitalisation for comfort or social reasons. 
- Emergency outpatient hospital consultation (without hospitalisation), unless one of the severity 
criteria described above applies. 
 
Monitoring of Serious Adverse Events 
The investigator will inform the PSAD service about any new information concerning an SAE within 24 hours 
of learning about it. 
All SAEs should, as much as possible, be monitored until they are resolved or stabilised (in the event of 
sequelae) within the limitations of the patient's participation in the study. 
 
Serious Adverse Events and Incidents Occurring After the Study 
All serious adverse events and incidents occurring after the patient's participation in the study, and 
considered to be related to the "closed loop" automated insulin delivery system (or "artificial pancreas"), will 
be managed by the PSAD service as standard medical device vigilance.  
 
Pregnancy 
Pregnancy is an exclusion criterion for the study. However, if a patient gets pregnant during the study period 
(from the time of signed informed consent until the patient's last assessment in the study), the pregnancy 
should be reported in the e-CRF as an adverse event. The patient will leave the study early. Partners of male 
patients included in the study are not affected by this process.  
 
New Facts 
A new fact is defined as any new piece of data that may lead to: 

 
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- 
Reassessment of the benefit-risk ratio of the research or the investigational medical device. 
- 
Changes in the use of this medical device, in the conduct of the research, or in research-related 
documents. 
- 
Suspension, interruption or amendment of the Protocol of the research or similar research. 
Any new fact will be reported promptly to the ANSM and CPP by the PSAD, who will pass the information on 
to the investigator. The investigator will then take the necessary measures for the patient in relation to this 
new fact. 
IX -  PROCESSING OF DATA 
IX.1 -  C A S E  R E P O R T  F O R M  (CRF) 
The data will be collected using an e-CRF, by the investigator or a member of the hospital team delegated by 
the investigator and by the PSAD nurse, with different connection profiles. The patient questionnaires will 
be entered in the e-CRF by the hospital team. 
Patients participating in the study will be identified by an 8-digit numeric patient code, consisting of the 
centre number prefixed by FR followed by 3 digits, and the 3-digit chronological order of inclusion number 
for the centre (FRYYY-XXX where FRYYY represents the centre number and XXX the patient number in 
chronological order of inclusion at the centre). 
For the clinical component, the patient's data will be collected from the source documents contained in the 
patient's medical file (original files, hospital reports, laboratory tests, various correspondence, investigator 
questionnaire, patient questionnaires, etc.) under the investigator's responsibility. 
The investigator or a person delegated from the centre should complete the e-CRF at the inclusion visit, 
during installation of the medical device and during the follow-up. All original source documents from which 
information is reported in the e-CRFs, should be kept up to date and be readily available. 
Data entry updates should be made by the investigator or a delegated person from the centre as soon as 
possible after each visit. 
All corrections relating to the clinical component of the e-CRF will be made by the investigator or a delegated 
person. 
After performing the data entry and resolving any requests for correction in the e-CRF, the investigator will 
validate all of the recorded data concerning the patient's clinical component, with their signature using their 
login details and access code. 
For the home healthcare service component, the PSAD nurse will complete the patient file contained in the 
PSAD's information system for each interaction (home visit, hospital visit or telephone contact) with the 
patient. The PSAD nurse will enter this data in the e-CRF as soon as possible after each interaction (home 
visit, hospital visit or telephone call), to keep the information up to date and readily available. All corrections 
relating to the home healthcare service component of the e-CRF will be made by the PSAD nurse. 
After performing data entry and resolving any requests for correction in the e-CRF, the PSAD nurse will 
validate all of the recorded data concerning the home healthcare service, with their signature using their 
login details and access code. 
The data collected in the e-CRF will be partially verified against the source data during follow-up visits by a 
Clinical Research Associate (CRA) from the CRO provider in the centre. 

 
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IX.2 -  D A T A  M A N A G E M E N T 
At the initiation of the study, the data manager will write all the Data Management steps to be followed and 
the applicable procedures in a manual. It will provide details on the data management system, users, 
applicable procedures, data flow, requests for corrections, organisation of data collection and coding 
methods. 
An electronic database specific to the study will be developed. Its characteristics will be described by an 
annotated CRF and dictionary of variables, which will be validated prior to the development of the electronic 
data collection tool. 
The e-CRF will be developed and validated before its entry into production. 
Check procedures for the reliability and validity of the data collected with the e-CRF will be defined and 
described in a data validation plan. These procedures will be defined to ensure the validity of the data in 
relation to the study's objectives and context. These checks will focus on the completeness and plausibility 
of the recorded values (bounds checking) and the compatibility of the various data (consistency checking). 
These checks will generate requests for clarification at the end of data entry on each page of the e-CRF. 
After performing data entry and resolving any requests for correction in the e-CRF, the investigator and PSAD 
nurse will validate all of the recorded data. They will each sign once per patient the data recorded in the e-
CRF for which they are responsible, using their login details and access code. 
After entering the data for all patients in the e-CRF, a data review meeting will be organised using tables, 
listings and graphs representing the database content. The strategy for factoring in missing, inconsistent or 
other problematic data will be determined in collaboration with the sponsor. All deviations from the Protocol 
will also be described, in particular the list of erroneously included patients. If it becomes necessary to define 
different patient populations for analysis, these populations will also be described. All decisions made during 
the data review, prior to analysis, will be recorded in a specific report kept in the Trial Master File. 
Once this report has been approved, the patient database will be locked and sent to the statistician for 
analysis. 
 
 

 
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X -  STATISTICAL ANALYSIS 
X.1 -  T H E  S A M P L E  S I Z E  
For reasons of feasibility, the number of patients to be included in the study was set at 35, for a number of 
expected evaluable subjects fixed at 32. Should any patients leave the study between the time of inclusion 
and the beginning of fitting the "closed-loop" automated insulin delivery system (or "artificial pancreas"), 
they will be replaced. 
This number of patients will be sufficient to estimate the percentage of patients satisfied on D90 with their 
management by the PSAD (the primary objective of the study), with an accuracy of ≤ 12.4%.   
In fact, whatever the criterion considered (satisfaction estimated from the CSQ-8 and satisfaction assessed 
from the answers to the various questions in the questionnaire "You and your management by your home 
healthcare provider" on D90), the expected percentage of satisfied patients is ≥ 85%. The formula used to 
estimate the accuracy is obtained from the definition of the 95% bilateral confidence interval (CI 95%) for a 
proportion p, with normal approximation 
𝐸= √ (1.96² p (1-p) / n) 
With n=32 evaluable patients, the accuracy will therefore be ≤ 12.4%. 
X.2 -  A N A L Y S I S  P O P U L A T I O N S  
X.2.1 -  D E F I N I T I O N  O F  T H E  P O P U L A T I O N S 
The following analysis populations will be defined: 
- 
Included patients: all patients included in the study who have signed a consent form 
 
- 
Intent-to-treat patients: all of the included patients fitted with the device who meet all of the 
inclusion and exclusion criteria 
 
- 
PSAD nurses: all PSAD nurses who answered the PSAD satisfaction questionnaire 
 
- 
Investigators: all investigators in the study 
X.2.2 -  D E V I A T I O N  F R O M  T H E  P R O T O C O L 
Before the database is frozen, deviations from the Protocol related to the inclusion/exclusion criteria will be 
reviewed. 
Patients who do not meet all of the inclusion/exclusion criteria will not be included in the intent-to-treat 
patient population. 
X.2.3 -  S U B- G R O U P S   
All analyses will be carried out as a whole and for the subgroup of patients who have previously used a 
"closed-loop" automated insulin delivery system (or "artificial pancreas") prior to their inclusion in the study. 
 

 
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X.3 -  S T A T I S T I C A L  A N A L Y S E S  
A Statistical Analysis Plan (SAP) will be drafted by the CRO in charge of the study and validated by the sponsor 
before the database is frozen. Statistical analyses will be carried out in SAS® version 9.2 or higher (SAS 
institute, North Carolina, USA). 
X.3.1 -  G E N E R A L  C O N S I D E R A T I O N S 
The continuous variables will be described in terms of mean, standard deviation, median, 1st and 3rd 
quartiles and extreme values. The categorical variables will be described in terms of absolute frequency and 
percentage per category. Ordinal variables will be described using the most appropriate method (continuous 
variables or categorical variables). Open-ended responses to questionnaires developed on an ad-hoc basis 
will be presented in the form of a list. 
95% bilateral confidence intervals (CI 95%) of percentages and/or averages will be calculated when deemed 
relevant. The confidence intervals of the percentages will be calculated using the Agresti-Coull method. For 
averages, the Wald 95% CIs will be calculated. 
The number of patients is small and the proportion of expected missing or invalid data is small and randomly 
distributed. Consequently, no imputation procedure for missing or invalid data will be applied. If necessary, 
the replacement of some of these data will be detailed in the SAP on a case-by-case basis. 
X.3.2 -  A V A I L A B I L I T Y  O F  T H E  P A T I E N T S 
The number of patients included, fitted with the device, prematurely discharged before being fitted and 
prematurely discharged after being fitted will be described. The reasons for early discharge will also be 
described. 
The analysis populations and number of patients per sub-group will also be described. 
X.3.3 -  D E M O G R A P H I C S  A N D  I N C L U S I O N  C H A R A C T E R I S T I C S 
Descriptive statistics (number, mean, standard deviation, median, Q1, Q3, minimum and maximum) will be 
used to present the inclusion characteristics and demographic data of intent-to-treat patients. 
X.3.4 -  A N A L Y S I S  O F  T H E  P R I M A R Y  A S S E S S M E N T  C R I T E R I O N 
To meet the main objective, the overall CSQ-8 score will be calculated at each time of assessment. The 
percentage of patients satisfied on D30 and D90 and the percentage of patients with continued satisfaction 
on D90 will be described. The 95% CIs will also be presented.  
The absolute variation of the overall CSQ-8 score and the relative variation in relation to D30 will also be 
described on D90. 
Each item of the questionnaire "You and your management by your service provider" will be described at 
each time of assessment. Scores based on the scales from 1 to 10 will be presented using descriptive 
statistics.   
 
 

 
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X.3.5 -  A N A L Y S I S  O F  S E C O N D A R Y  A S S E S S M E N T  C R I T E R I A  
Home healthcare provider (PSAD) management 
Management description 
For each phase of the study (pre-installation, installation and follow-up), the number of interactions will be 
described. The type of interaction (visits/telephone calls), the time spent per interaction, the main reason 
and secondary reason for making contact will also be presented. 
To verify whether the PSAD patient follow-up is consistent with the follow-up expected, the number and 
percentage of patients who required increased follow-up/support, identical follow-up/support and reduced 
follow-up/support in relation to what was recommended in the opinion of the HAS dated 28 January 2020 
for the Diabeloop DBLG1TM system will be described.  The theoretical aspects of management recommended 
in this HAS opinion will be extrapolated/applied to all the “closed-loop” systems used in the study. The 95% 
CIs of the percentages will be calculated.  
Knowledge acquired by the patient 
For each item of the patient acquired knowledge assessment questionnaire, the percentage of patients for 
whom the item is not addressed/not acquired/in progress/acquired will be described on D1/D3, D30 and 
D90.  
PSAD nurse satisfaction 
Responses to all items in the PSAD satisfaction questionnaire will be described for the PSAD nurse population. 
The answers to text entry fields will be presented in a list. 
 
Patient questionnaire 
Patient's profile in relation to their experience with devices 
Each item of the "You and medical devices" questionnaire will be described qualitatively and/or 
quantitatively at inclusion. 
Patient's feelings about their current and future state of health 
At inclusion and on D90, the percentage of patients who think their health is Excellent/ Very Good / Good / 
Poor / Very Poor and who look ahead at their future life with diabetes With great confidence / With 
Confidence / With concern / With great concern will be described. 
On D90, the percentage of patients whose feelings about their state of health improved will be described. 
Quality of life and daily constraints 
The EQ-5D score will be calculated at inclusion, on D30 and D90 together with the absolute and relative 
variations on D30 and D90 compared to the time of inclusion.  
For each of the 5 dimensions in the questionnaire, the percentage of patients for each perception level will 
be presented at inclusion, on D30 and D90.  In addition, the levels will be dichotomised into no problems 
(level 1) and problems (levels 2 to 5). The percentage of patients with no problems / with problems will be 
presented for each dimension. 
The EQ-VAS score at inclusion, on D30 and D90, as well as the absolute and relative variations of the EQ-VAS 
score will be presented.  
For each item in the "You and your daily constraints" questionnaire, the percentage of patients with this 
constraint will be described at inclusion, on D30 and D90. The number of constraints ticked by the patient 
will also be presented. 
The total HFS-II score and the scores from the two sub-categories, “HFS-B” and “HFS-W”, will be presented 
at inclusion, on D30 and on D90, along with the absolute and relative variations on D30 and D90 compared 
with the time of inclusion. 
Expected and perceived benefits  

 
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For each item in the "You and the "closed-loop" automated insulin delivery system (or "artificial pancreas")" 
questionnaire, the percentage of patients who answered "Yes, I hope so " or "I don't have any expectations 
regarding this matter" will be described at inclusion. The confidence level score for the technical use of the 
system will also be prepared. 
On D30 and D90, for each item of the questionnaire, the percentage of patients who answered "Yes, I 
perceived benefits" or "I didn't perceive any benefits" will be described. The confidence level score on D30 
and D90, as well as the absolute and relative variation compared to the time of inclusion will also be 
described. 
Beliefs about the medical treatment 
For each BMQ-specific question, the percentage of patients who answered: strongly disagree / disagree / 
uncertain / agree / strongly agree will be described. 
The BMQ-specific score related to the need for the treatment and the score relating to concerns will be 
described at inclusion, on D30 and D90. The absolute and relative variations in these two scores compared 
to the time of inclusion will be calculated on D30 and D90.  
 
Investigator questionnaire 
Responses to all items in the investigator questionnaire will be described for the investigator population. The 
answers to text entry fields will be presented in a list. 
 
Clinical course 
The average HbA1C value will be described at installation and on D90. The percentage of patients with an 
HbA1C < 7% will also be calculated at installation and on D90.  
The parameters below will be presented using descriptive statistics: 
- 
Percentage of time spent over a 4-week period (if available) in the blood sugar target, 
hypoglycaemia and hyperglycaemia, at inclusion, on D30 and on D90.  
- 
Percentage of time spent using a closed-loop system over a 4-week period (if available) on D30 
and D90.  
- 
Daily average blood sugar level and its variability (standard deviation and coefficient of variation, 
if applicable) at inclusion, on D30 and D90. 
 
Safety 
The incidence rate of adverse events, SAEs, as well as those related to the "closed-loop" automated insulin 
delivery system (or "artificial pancreas"), will be presented as a whole and by "System Organ Class" and 
"Preferred term" in the MedDRA terminology. 
The percentage of patients with at least one episode and the average number of episodes will be described 
for the following: 
- 
Episodes of severe hypoglycaemia requiring the intervention of a third party for glucose 
administration. 
- 
Episodes of hyperglycaemia with ketosis. 
In addition, the number of incidents associated with the device will be described. 
X.3.6 -  A N A L Y S I S  O F  T H E  E X P L O R A T O R Y  C R I T E R I A 
All the parameters of the economic assessment of the service in volume and costs detailed in section VI.10.11 
- will be described.  

 
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A descriptive statistical analysis of all exploratory parameters will be carried out. 
Cost calculations will be detailed in the SAP. 
 
 

 
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X.4 -  M A N A G I N G  C H A N G E S  T O  T H E  I N I T I A L  M E T H O D S  O F  S T A T I S T I C A L  
A N A L Y S I S 
Any changes made to the initial statistical methodology, along with the reasons for such changes, will be 
described in a specific section of the Statistical Analysis Plan (SAP) and in the clinical study report. 
XI -  QUALITY CONTROL/MONITORING 
Monitoring involves keeping track of the study as it progresses, to ensure it is being conducted and that data 
are collected and reported in accordance with the Protocol, Standard Operating Procedures (SOP), Clinical 
Best Practices (CBP) and applicable laws and regulations. 
The main responsibilities of the Clinical Research Associate (CRA) are ensuring the investigators comply with 
the Protocol and that informed consent is obtained and recorded before any study procedure is 
implemented. 
Continuous monitoring of the centre: 
During the study, the CRA will regularly contact the centre (investigator and hospital team) to monitor patient 
recruitment, to check that a centre staff member is completing the e-CRF and entering the patient 
questionnaires, and to monitor patient safety and the resolution of any correction requests 
The CRA will participate in explaining the study Protocol and procedures to all centre staff members involved, 
including the investigator. If new employees become involved during the course of study, additional training 
sessions will be organised by the investigator and the CRA. 
Monitoring visit: 
For each active centre, the CRA, assigned by the sponsor, will contact the investigator to conduct monitoring 
visits. 
During these site visits, the CRA will compare the data recorded in the e-CRF against the medical files, the 
questionnaires completed in the e-CRF, the patient questionnaires entered in the e-CRF and other 
documentation through direct access. They will ensure that the data recorded in the e-CRF are complete, 
consistent and accurate. The data will be verified in accordance with a Monitoring Plan. 
As part of the study monitoring, certain sponsor or CRO staff may accompany the CRA during their on-site 
visit. The investigator and members of their team undertake to cooperate with the CRA to resolve any 
problems, corrections or possible misinterpretations identified during these monitoring visits. 
 
 

 
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XII -  RESPONSIBILITIES 
XII.1 -  The s P O N S O R ' S  R E S P O N S I B I L I T I E S  
The sponsor will submit the study to the CPP for their opinion, inform the ANSM of this study and provide it 
with the CPP's positive recommendation. The CPP's positive recommendation must have been received by 
the sponsor before the study began. 
In accordance with the regulations and CBP, the sponsor will take out civil liability insurance to cover any 
damage that may result from the research. 
XII.2 -  T H E  I N V E S T I G A T O R ' S  R E S P O N S I B I L I T I E S  
The investigator must ensure the accuracy, completeness, legibility and timeliness of the reported data. All 
source documents must be completed legibly and carefully and kept up to date to ensure accurate 
interpretation of the data. 
The investigator will maintain up-to-date appropriate and accurate records in accordance with CBP to ensure 
the study's conduct is properly documented and the data can subsequently be verified during the study's 
monitoring, audits and regulatory inspections. 
The investigator must inform and train all members of their team involved in the study or in patient 
management, including the PSAD nurses involved in the study, before any procedure is implemented and 
throughout the study (e.g. if a new member becomes involved). 
The investigator will maintain an up-to-date record of all staff members involved in the study (physician, 
hospital nurse, PSAD nurse and others) and will specify the delegated tasks of each member for the study. 
The investigator is responsible for ensuring the privacy, health and well-being of patients both during and 
after the study. 
The investigator should be familiar with the context and requirements of the study and must comply with 
the recommendations set out in the user manuals for the "closed-loop" automated insulin delivery systems 
(or "artificial pancreas").  
By signing the Protocol's signature page, the investigator undertakes to fulfil their assigned responsibilities. 
 
XIII -  CONFIDENTIALITY AND ARCHIVING 
XIII.1 -  P R O T E C T I O N  O F  P E R S O N A L  D A T A  A N D  C O N F I D E N T I A L I T Y 
The investigator must ensure that patients' personal data, including their identity and medical information, 
are kept confidential at all times. 
Patients will be identified by a number on the case report form (centre number-patient number in order of 
inclusion). On other study documents provided to the sponsor (patient questionnaires, etc.), patients will 
only be identified by the above-mentioned number. 
By signing this Protocol, the investigator agrees that this Protocol and all accompanying information are and 
will remain confidential. The investigator accepts that after providing this Protocol and the necessary 
information to the staff involved, they remain responsible for their complete confidentiality.  

 
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In accordance with local regulations and ethical considerations, the investigator consents to allowing a 
representative of the sponsor or the ANSM to directly consult and/or copy any study document, ensuring 
that the patient's identity remains confidential, while allowing the representative to check the case report 
form. 
The investigator undertakes to manage all patient data used or disclosed in the study in accordance with 
local legislation and European data protection laws. 
The investigator must maintain an up-to-date confidential correspondence list for the included patients, 
including their number, name and date of birth. 
The data will be recorded and analysed in accordance with the CNIL's compliance undertaking MR-001 
(Reference Methodology 001) (see section XIV.5.1). 
The sponsor has the right to use and analyse all anonymous data collected in this study. The data are 
inspected, in accordance with the regulations in force and in particular Regulation (EU) 2016/679 of the 
European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to 
the processing of personal data and on the free movement of such data (General Data Protection Regulation 
- GDPR), in addition to the current version of Law No. 78-17 of 6 January 1978 on information technology, 
data files and civil liberties. 
The contact details of the Data Protection Officer appointed by the sponsor are: 
Air Liquide  
Déléguée à la Protection des Données 
75, Quai d'Orsay 
75007 Paris - France 
https://www.airliquide.com/fr/groupe/contactez-nous-rgpd 
The data may be transmitted to companies acting on behalf of the sponsor and located in countries inside or 
outside the European Union that would be able to guarantee an adequate level of personal data protection 
for the administration of the study. 
XIII.2 -  R E T E N T I O N  O F  S T U D Y  D O C U M E N T S 
The investigator must maintain the study records in an adequate and accurate manner to ensure that the 
study's documentation is complete and correct and can be duly verified. Study documents, including case 
report forms, will be filed in the investigator file. 
The investigator file will contain the Protocol, its amendments, the CPP's recommendation along with the 
relevant correspondence, the informed consent form, records relating to the MD, staff CVs, task delegations 
and correspondence, etc. 
The investigator must keep the study file for 15 years from the date of the last publication concerning the 
study. 
In the event that the investigator wishes to transfer the study file to a third party or move it to another 
location, the sponsor must be informed in advance. 
 
 

 
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XIV -  ETHICAL AND REGULATORY CONSIDERATIONS 
XIV.1 -  P A T I E N T  I N F O R M A T I O N  L E A F L E T  A N D  I N F O R M E D  C O N S E N T  F O R M  
The investigator (or any other person designated by the investigator in accordance with regulatory 
requirements) will provide patients with the information leaflet, which must be easy to understand, before 
any acceptance or refusal of participation in accordance with local regulations and Clinical Best Practices. 
This information is based on the principles set out in the Declaration of Helsinki and CBP recommendations. 
It must also describe the measures in place to protect the privacy and personal data of patients, in accordance 
with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data (General Data Protection Regulation - GDPR), in addition to the current version of Law No. 78-17 
of 6 January 1978 on information technology, data files and civil liberties. 
The investigator (or the person designated by the investigator in accordance with regulatory requirements) 
must provide patients with an easy to understand oral explanation of the study in which they are invited to 
participate, which includes a discussion of the investigational medical device, the expected benefits and any 
potential risks or disadvantages that could be encountered during the study, the implications and any other 
aspect of the study that is relevant to the patients' decision to participate, and they must also answer any 
questions patients may have regarding the study. The investigator must ensure that patients have 
understood the information and give them enough time to carefully consider whether or not they wish to 
participate in the study. 
The investigator should explain to patients that they are completely free to refuse to participate in the study 
or to discontinue their participation in the study at any time, without having to justify their decision and 
without this affecting their relationship with the investigator or their future medical care. 
Each patient will be informed that part of their original medical file and baseline data related to the clinical 
study will be reviewed by the Clinical Research Associate (CRA), and possibly by an auditor appointed by the 
sponsor or a regulatory authority, in accordance with the applicable local regulatory requirements. 
The patient gives their free and informed consent by dating and signing the consent form before any study 
procedure is implemented.  
A copy of the informed consent form will be made: the original is kept by the investigator and the copy is 
given to the patient. 
If any new information becomes available during the course of the study that may affect the patient's 
willingness to participate in the study, they should be given a new and updated informed consent form so 
they can give their consent to their continued participation. 
 
 

 
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XIV.2 -  A C C E S S  T O  S O U R C E  D A T A  
The investigator must provide the CRA with direct access to any source documents relating to the patient 
that may be required to verify the data recorded in the case report form. 
With regard to electronic patient records, if they do not come from validated software with an audit trail and 
if access cannot be limited to the patients in the study, the investigator must provide a signed hard copy of 
the electronic medical records during the CRA's visits. 
If so requested by the relevant authorities, the investigator must provide access to all study data. 
In accordance with the regulations and CBP recommendations, the patient will be informed in writing of the 
need to verify their data in the medical file for quality control, audit or inspection. 
XIV.3 -  C O N D U C T  O F  T H E  S T U D Y 
The study will be conducted in accordance with Clinical Best Practices (CBP), the Declaration of Helsinki and 
applicable European and/or local laws and regulations related to the proper conduct of clinical studies. 
XIV.4 -  E T H I C S  C O M M I T T E E  A N D  R E L E V A N T  A U T H O R I T Y 
The sponsor will submit this Protocol along with the other essential study documents to the CPP. Before 
starting the study, the investigator should have received a positive recommendation from the CPP for the 
Protocol and the patient informed consent form.  This positive recommendation from the CPP will be 
forwarded to the ANSM as soon as it has been received. 
The CPP and the ANSM will be informed of the implementation and completion of the study. 
During the course of the study, the sponsor must inform the CPP of any changes to the Protocol and/or 
essential documents (see section XIV.6). 
Medical device vigilance cases will be reported to the relevant authorities (see section VIII). 
XIV.5 -  S P E C I F I C  N A T I O N A L  P R O C E D U R E S 
XIV.5.1 -  C O M M I S S I O N  N A T I O N A L E  D E  L ’I N F O R M A T I Q U E  E T  D E S  
L I B E R T E S  [F R E N C H  D A T A  P R O T E C T I O N  A U T H O R I T Y ]  (CNIL) 
In accordance with the current version of the French Law 78-17 called"Informatique et Libertés" of 6 January 
1978 and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data (General Data Protection Regulation - GDPR), the sponsor has undertaken to comply with the CNIL's 
MR-001 Reference Methodology. 
Patients will be informed that their personal data, collected as part of the study, will be kept confidential and 
will be processed electronically in countries inside or outside the European Union under the responsibility of 
the sponsor. They will also be informed of their rights regarding the processing of their data. They will be 
given an information leaflet and an informed consent form that must be signed prior to any study procedure 
taking place. 
XIV.5.2 -  C O N S E I L  N A T I O N A L  D E  L ’O R D R E  D E S  M E D E C I N S  [F R E N C H  
N A T I O N A L  M E D I C A L  C O U N C I L]  (CNOM) 

 
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In accordance with article R1121-3-1 of the French Public Health Code, a tripartite financial agreement, called 
the "Convention Unique", will be signed by the sponsor, the healthcare facility, the investigator and the PSAD, 
and will be sent to the CNOM for information purposes. 
In accordance with French Act No. 2011-2012 of 29 December 2011 and its implementing Decree No. 2013-
414 of 21 May 2013 relating to the transparency of potential conflict of interests, the sponsor will publish 
the existence of this agreement as well as the benefits, in cash or in kind, provided directly or indirectly to 
the investigator. 
XIV.6 -  A M E N D M E N T S 
Neither the investigator nor the sponsor may amend the Protocol without the consent of the other party. 
Any amendments that are likely to be issued must be dated and signed by both parties and must appear as 
amendments to the Protocol before implementation. 
Substantial amendments must be submitted to the CPP for its opinion before the changes are implemented. 
The positive recommendation(s) obtained will be sent to the ANSM for information purposes. 
A substantial amendment is an amendment that has a significant impact on the safety integrity of the study's 
patients, the scientific value or conduct of the study, or the quality or safety of the medical device.  
Substantial amendments pertaining to safety measures will be submitted to the CPP for its opinion but may 
be implemented immediately under specific conditions defined by the sponsor. 
Non-substantial amendments are not submitted to the CPP, but the related changes, whose documentation 
is kept by the sponsor are highlighted upon submission of any subsequent substantial amendments.  
XIV.7 -  A U D I T  A N D  I N S P E C T I O N 
The investigator must consent to making the study source documents available to the auditors (qualified 
personnel of the sponsor or its representative) or health authority inspectors. The investigator will make 
themselves available to answer any questions raised by the auditors/inspectors and will do everything 
possible to facilitate the audit/inspection process. 
In the event of an inspection, the investigator may inform the sponsor. 
 
 

 
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XV -  PUBLICATION OF DATA 
All data and results from the study are the exclusive property of the sponsor. They must be neither 
communicated nor published without the prior authorisation of the sponsor. 
The sponsor reserves the right to publish or use them in any form whatsoever, to submit them for registration 
to the health authorities of any country, on its own behalf or on behalf of its subsidiaries. 
The investigators should inform the sponsor of any plans to publish or present the study data. Any publication 
or presentation of the results (abstracts in scientific journals or reviews, oral presentations, etc.), in whole or 
in part, by the investigators or their representatives should be reviewed by the sponsor before submission. 
In the event that the study generates patentable results, the sponsor will be authorised to file such a patent, 
on their own behalf and at their own expense. 
The final clinical study report will be prepared in accordance with applicable regulations. 
 
 
 

 
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