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

NCT ID: NCT04522882

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2020-12-31

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.

Conditions

Type 2 Diabetes Treated With Insulin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Actimetry

Intervention Type: DEVICE

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

Questionnaires

Intervention Type: OTHER

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

Glucose level and insulin administration

Intervention Type: OTHER

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 .

Interventions

Actimetry

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

Intervention Type: DEVICE

Questionnaires

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

Intervention Type: 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 .

Intervention Type: OTHER

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icadom

INDUSTRY

Sponsor Role: collaborator

AGIR à Dom

OTHER

Sponsor Role: collaborator

CHU Grenoble Alpes

UNKNOWN

Sponsor Role: collaborator

Diabeloop

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Laure BOREL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

AGIRADOM

Meylan, , France

Countries

France

Other Identifiers

RCB 2020-A01710-39

Identifier Type: -

Identifier Source: org_study_id