NCT04522882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 11, 2021

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

July 23, 2020

Last Update Submit

June 10, 2021

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Type 2 diabetesInsulinLife conditionsAlgorithmClosed loop

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Physical activity

    7 days

  • Physical activity

    7 days

  • Sleep duration

    7 days

  • Sleep duration

    7 days

  • Patient's chronotype

    7 days

  • +3 more secondary outcomes

Study Arms (1)

At home clinical data collection

EXPERIMENTAL

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

Device: ActimetryOther: QuestionnairesOther: Glucose level and insulin administration

Interventions

ActimetryDEVICE

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

At home clinical data collection
QuestionnairesOTHER

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

At home clinical data collection
Glucose level and insulin administrationOTHER

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 .

At home clinical data collection

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with T1D
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AGIRADOM

Meylan, 38140, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Anne-Laure BOREL, MD, PhD

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Actimetry is performed in all patients included.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2020

First Posted

August 21, 2020

Study Start

September 9, 2020

Primary Completion

November 6, 2020

Study Completion

December 31, 2020

Last Updated

June 11, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)