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Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)

NCT05369871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-07

No results posted yet for this study

Summary

The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with type 2 diabetes (T2D) treated with insulin pumps.

Conditions

  • Diabetes Mellitus Type 2 - Insulin-Treated

Interventions

DEVICE

Closed-loop system

Closed-loop system consisting of a terminal including the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the Accu-Chek Insight insulin pump.

DEVICE

Open-loop system

Open-loop system consisting of a terminal without the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the usual insulin pump.

Sponsors & Collaborators

  • Icadom

    collaborator INDUSTRY

  • AGIR à Dom

    collaborator OTHER

  • University Hospital, Grenoble

    collaborator OTHER

  • Centre Hospitalier Annecy Genevois

    collaborator OTHER

  • Centre Hospitalier Metropole Savoie

    collaborator OTHER

  • Diabeloop

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-29
Primary Completion
2023-05-09
Completion
2023-07-28

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 NCT05369871 on ClinicalTrials.gov