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Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8)

NCT04190277 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2021-04-08

No results posted yet for this study

Summary

This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.

* Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.
* Then, a 3-month study phase will be performed during 12 weeks:

* 1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition).
* 2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition).
* An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.

Conditions

  • Diabetes Mellitus, Type 1
  • Closed-Loop

Interventions

DEVICE

Open-loop condition

Patient's standard insulin pump setting combined with continuous glucose monitoring sensor

DEVICE

Closed-loop condition

Closed-loop algorithm system paired with continuous glucose monitoring sensor

Sponsors & Collaborators

  • Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

    lead OTHER

Principal Investigators

  • Sylvia FRANC, Dr · Sud Francilien Hospital, Corbeil-Essonnes

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2020-03-16
Completion
2020-06-16

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 NCT04190277 on ClinicalTrials.gov