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Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia

NCT04266379 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-12-15

No results posted yet for this study

Summary

This study is a RCT of 3 month at home comparing closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase, in Type 1 diabetic patient prone to hypoglycemia. After a 2-week run-in phase with blinded CGM, patients who spent 5% or more time below 70mg/dL will be eligible to continue. They will will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S\&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S\&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.

Conditions

  • Type 1 Diabetes Mellitus With Hypoglycemia

Interventions

DEVICE

Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions

Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data

DEVICE

Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring

Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • DexCom, Inc.

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Virginia

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2022-11-03
Completion
2023-02-03
FDA Device
Yes

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 NCT04266379 on ClinicalTrials.gov