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

NCT04522882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-06-11

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Treated With Insulin

Interventions

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 .

Sponsors & Collaborators

  • Icadom

    collaborator INDUSTRY

  • AGIR à Dom

    collaborator OTHER

  • CHU Grenoble Alpes

    collaborator UNKNOWN

  • Diabeloop

    lead INDUSTRY

Principal Investigators

  • Anne-Laure BOREL, MD, PhD · CHU Grenoble Alpes

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2020-11-06
Completion
2020-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04522882 on ClinicalTrials.gov