Clinical trial NCT04522882: Clinical Data Collection for the Closed Loop Development for the Type 2 Diabetes Treatment - DT2_1
Official title: Development of a Closed Loop for the Treatment of Type 2 Diabetes: Collection of Clinical Data at Home for the Creation of an Algorithmic Laboratory Test Bench
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Type 2 diabetes
Insulin
Life conditions
Algorithm
Closed loop
Lead sponsor: Diabeloop
Sponsor class: INDUSTRY
Collaborators: name: Icadom
name: AGIR à Dom
name: CHU Grenoble Alpes
First posted: 2020-08-21
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Actimetry is performed in all patients included.
Primary purpose: OTHER

Brief summary: The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.

Detailed description: T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.

Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin secretion. Currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. Artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. These devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life.

These very significant benefits in the T1D treatment open the possibility of obtaining similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims to develop a specific algorithm of T2D to meet its particular characteristics.

The objective of this study is to collect the evolution of blood glucose levels in T2D patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.

Eligibility criteria: Inclusion Criteria:

* Patient with T2D treated with insulin pump for at least 6 months
* Patient with a body mass index (BMI) between 27 and 40 kg/m2
* Patient treated with a total daily dose of insulin between 40 and 300 U/24 h
* Patient with CGM
* Patient with Social security or beneficiary
* Patient able to read and understand the procedure, and able to express consent for the study protocol

Exclusion Criteria:

* Patient with T1D
* Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
* Persons referred to in articles L.1121-5 to L.1121-8 of the CSP (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)

Primary outcomes:
measure: Glucose level modification
timeFrame: 7 days
Secondary outcomes:
measure: Physical activity
timeFrame: 7 days
measure: Physical activity
timeFrame: 7 days
measure: Sleep duration
timeFrame: 7 days
measure: Sleep duration
timeFrame: 7 days
measure: Patient's chronotype
timeFrame: 7 days
measure: Patient's chronotype
timeFrame: 7 days
measure: Schedule and type of food intake
timeFrame: 7 days
measure: Medication intake
timeFrame: 7 days
Other outcomes:
Locations:
city: Meylan
country: France
facility: AGIRADOM
Study officials:
affiliation: CHU Grenoble Alpes
name: Anne-Laure BOREL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: