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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: Actimetry; Other: Questionnaires; Other: Glucose level and insulin administration

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Meylan, France, 38140
    • AGIRADOM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose level modification	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.	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diabeloop
• Collaborators: AGIR à Dom; Icadom; CHU Grenoble Alpes
• Investigators: Principal Investigator: Anne-Laure BOREL, MD, PhD, CHU Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Insulin; Type 2 diabetes; Closed loop; Algorithm; Life conditions
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: RCB 2020-A01710-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No