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Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes

NCT02892604 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-12-09

No results posted yet for this study

Summary

A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.

Conditions

Interventions

DEVICE

insulin pump to inControl AP platform

Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.

Sponsors & Collaborators

  • MEDBIOMED, Montpellier, France

    collaborator UNKNOWN

  • Jaeb Center for Health Research

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Eric M RENARD, MD, PhD · University Hospital, Montpellier

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-11-24
Primary Completion
2017-06-24
Completion
2017-06-24

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT02892604 on ClinicalTrials.gov