Clinical Data Collection for the Closed Loop Development for the Type 2 Diabetes Treatment - DT2_1

Sponsor

Diabeloop (Industry)

Overall Status

Completed

CT.gov ID

NCT04522882

Collaborator

Icadom (Industry), AGIR à Dom (Other), CHU Grenoble Alpes (Other)

Enrollment

Location

Arm

3.7

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Treated With Insulin	Device: Actimetry Other: Questionnaires Other: Glucose level and insulin administration	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Actimetry is performed in all patients included.Actimetry is performed in all patients included.

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 9, 2020

Actual Primary Completion Date :

Nov 6, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: At home clinical data collection Clinical data will be collected during 7 days: physical activity, sleep duration, chronotype, food and medication intake, glucose level and insulin administration.	Device: Actimetry Actimetry will be performed at home to measure physical activity, sleep duration and patient chronotype for 7 days. Other: Questionnaires Patients will complete food and medication intake questionnaires for 7 days. Other: Glucose level and insulin administration Continuous subcutaneous glucose level (measured by continuous glucose monitor (CGM)) and the insulin doses delivered by the insulin pump will be collected for 7 days .

Arm

Intervention/Treatment

Experimental: At home clinical data collection

Clinical data will be collected during 7 days: physical activity, sleep duration, chronotype, food and medication intake, glucose level and insulin administration.

Device: Actimetry

Actimetry will be performed at home to measure physical activity, sleep duration and patient chronotype for 7 days.

Other: Questionnaires

Patients will complete food and medication intake questionnaires for 7 days.

Other: Glucose level and insulin administration

Continuous subcutaneous glucose level (measured by continuous glucose monitor (CGM)) and the insulin doses delivered by the insulin pump will be collected for 7 days .

Outcome Measures

Primary Outcome Measures

Glucose level modification [7 days]
Continuous subcutaneous glucose level (measured by continuous glucose sensor (CGM)) for 7 days, compared to the daily activities collected and the insulin doses delivered by the insulin pump.

Secondary Outcome Measures

Physical activity [7 days]
Measured by actimetry
Physical activity [7 days]
Measured by physical actimetry journal
Sleep duration [7 days]
Measured by actimetry
Sleep duration [7 days]
Measured by sleep journal
Patient's chronotype [7 days]
Measured by actimetry
Patient's chronotype [7 days]
Measured by sleep journal
Schedule and type of food intake [7 days]
Questionnaire on schedule and type of food intake (without score on a scale)
Medication intake [7 days]
Questionnaire on medication intake (without score on a scale)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)