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

Sponsors

Lead Sponsor: Diabeloop

Collaborator: Icadom
AGIR à Dom
CHU Grenoble Alpes

Source Diabeloop
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.

Overall Status Recruiting
Start Date September 9, 2020
Completion Date December 2020
Primary Completion Date November 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glucose level modification 7 days
Secondary Outcome
Measure Time Frame
Physical activity 7 days
Physical activity 7 days
Sleep duration 7 days
Sleep duration 7 days
Patient's chronotype 7 days
Patient's chronotype 7 days
Schedule and type of food intake 7 days
Medication intake 7 days
Enrollment 35
Condition
Intervention

Intervention Type: Device

Intervention Name: Actimetry

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

Arm Group Label: At home clinical data collection

Intervention Type: Other

Intervention Name: Questionnaires

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

Arm Group Label: At home clinical data collection

Intervention Type: Other

Intervention Name: Glucose level and insulin administration

Description: 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 Group Label: At home clinical data collection

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)

Gender: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Anne-Laure BOREL, MD, PhD Principal Investigator CHU Grenoble Alpes
Overall Contact

Last Name: Maud PLOMBAS

Phone: 336 850 238 08

Email: [email protected]

Location
Facility: Status: Contact: Investigator: AGIRADOM Marie JOYEUX-FAURE, PharmD 336 780 232 06 [email protected] Sandrine LAFORGE, nurse Principal Investigator Geraldine BERGEAUD, nurse Sub-Investigator Audrey DUSART, nurse Sub-Investigator Sothearot IM, nurse Sub-Investigator Fanny LIEVAUX, nurse Sub-Investigator Audrey LISMONDE, nurse Sub-Investigator Claudie TRIBOUILLER, nurse Sub-Investigator
Location Countries

France

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: At home clinical data collection

Type: Experimental

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

Acronym DT2_1
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Actimetry is performed in all patients included.

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov