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

Type 2 Diabetes Treated With Insulin Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522882
• Other study ID #: RCB 2020-A01710-39
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Diabeloop
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 ß-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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

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.
• 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 .

Locations

Country	Name	City	State
France	AGIRADOM	Meylan

Sponsors (4)

Lead Sponsor	Collaborator
Diabeloop	AGIR à Dom, CHU Grenoble Alpes, Icadom

Country where clinical trial is conducted

France, 

Outcome

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