Clinical trial NCT04635280: Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes type1
Keywords: Artificial pancreas
Patient management
Technical telemonitoring
Home Healthcare Provider
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: SATURN study aims at evaluating Home Healthcare Provider (HHP) Management of type 1 diabetic patients using a closed-loop automatic insulin delivery system (or artificial pancreas), and specifically satisfaction and interactions of all people involved (patients, HHPs, hospital healthcare teams) after 1 and 3 months of follow-up, under normal conditions of use.

Detailed description: National, multi-centre, longitudinal, non-comparative interventional study with minimal risks and constraints.

Two French hospitals and their HHP representatives will participate in the study. A recruitment of a total of 35 patients is expected.

Adult type 1 diabetic patients for whom the investigator prescribes the use of a closed-loop automatic insulin delivery system (or artificial pancreas) consisting in an insulin pump with a continuous glucose monitoring system combined with a dedicated terminal.

Patients will be monitored for a period of 3 months, starting from the end of the device installation procedure.

HHP Management comprises three distinct phases: pre-installation, installation and follow-up during which number, nature and duration of contacts (visits/telephone calls) may vary according to patient's needs, investigator's judgement and practice, and judgement of HHP staff.

Pre-installation and installation phases consist of two patients' visits at hospital, and of two to five visits from HHP staff to patients' home (only one visit at hospital). Follow-up phase held after installation consists of four patients' contacts (phone contact and/or home visit) performed by HHP staff.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patient diagnosed for at least 2 years
* Patient treated with an external insulin pump for at least 6 months
* Patient with an HbA1c level less than or equal to 10% in the past 4 months
* Patient with U100 short-acting insulin (Novorapid or Humalog) requirements between the lower and upper bounds set by the pump of the closed-loop automatic insulin delivery system (or artificial pancreas)
* Patient who is not isolated, who does not live alone or who has a "resource" person living nearby with her/his own telephone and a key to the patient's home
* Patient living in an area covered by a Global System for Mobile Communications (GSM) network and not planning to travel outside France or outside an area covered by a GSM network within 30 days of the closed-loop automatic insulin delivery system (or artificial pancreas) being installed
* Patient at least 18 years old and whose age complies with the eligibility criteria for each medical device of the closed-loop automatic insulin delivery system (or artificial pancreas)
* Patient registered with a Social Security scheme
* Patient who has agreed to comply with the requirements of the study and has signed the free and informed consent form
* Patient who the investigator deems capable of using a closed-loop automatic insulin delivery system (or artificial pancreas) under normal conditions of use.

Exclusion Criteria:

* Patient with any serious pathology that could affect his/her participation in the study
* 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
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* Absence of contraception deemed effective by the investigator for a woman of child-bearing age
* Psychological and/or physical state which could affect the proper follow-up of the study procedures
* Severe hypoglycaemia which has led to convulsions or a loss of consciousness in the last 12 months
* Decrease in the perceived sensation of hypoglycaemia, in the investigator's judgement
* Altered renal function (creatinine clearance \< 30 ml/min measured in the last 6 months)
* Patient who has had a pancreas or pancreatic islet transplant
* Patient with serious uncorrected hearing and/or visual problems
* Patient included in another clinical study or who has taken part in another clinical study in the last 30 days

Primary outcomes:
measure: Number of Participants With Satisfaction Regarding the Management in General, at Day 30 and Day 90, by the CSQ-8 Questionnaire
timeFrame: Day 30 and Day 90
measure: Number of Participants With Maintenance of Global Patient Satisfaction Regarding the Management in General, at Day 90, by the CSQ-8 Questionnaire
timeFrame: Day 90
measure: Description of Patient Satisfaction and Experience Regarding the Management by HHP at Day 30 and Day 90
timeFrame: Day 30 and Day 90
Secondary outcomes:
measure: Total Number of HHP Interactions
timeFrame: Throughout the study, up to 3 months
measure: Cumulative Duration of HHP Interactions
timeFrame: Throughout the study, up to 3 months
measure: Comparison of the HHP Observed Management With the Theoretical Management Described in the Medical Device's Information Record.
timeFrame: Throughout the study, up to 3 months
measure: Quality of Life Questionnaire (EQ-5D) Summary Index at Inclusion, Day 30 and Day 90
timeFrame: At inclusion, Day 30 and Day 90
measure: Hypoglycaemia Fear Survey (HFS) Total Score at Inclusion, Day 30 and Day 90
timeFrame: At inclusion, Day 30 and Day 90.
measure: Number of Daily Constraints Encountered by Patients on the Past Month at Inclusion, Day 30 and Day 90
timeFrame: At inclusion, Day 30 and Day 90
measure: Number of Participants Who Expected and Perceived Benefits With Respect to the Closed-loop Automated Insulin Delivery System at Inclusion and Day 90
timeFrame: At inclusion and Day 90
measure: Beliefs About Medicines Questionnaire (BMQ) Scores at Inclusion and D90
timeFrame: At inclusion and Day 90
measure: HbA1c at Inclusion and Day 90
timeFrame: Inclusion and Day 90
measure: Glycemic Variability at Inclusion and Day 90
timeFrame: At inclusion and Day 90
measure: Percentage of Time Spent Over a 4-week Period in Glycemic Target Range at Inclusion and Day 90
timeFrame: At inclusion and Day 90
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Nord Laennec
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Rangueil
Study officials:
affiliation: Hôpital de Rangueil - 31059 Toulouse - France
name: Hélène HANAIRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: