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Diabeloop for Teens

NCT04725591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-09-26

No results posted yet for this study

Summary

An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.

Conditions

  • Closed Loop
  • Diabetes Mellitus, Type 1
  • Adolescents (12 to 17 Years Old)

Interventions

DEVICE

Dexcom G6 Continuous Glucose Monitoring

Collection of glucose data

DEVICE

MEDISAFE WITH External Insulin Pump

Insulin delivery

DEVICE

Diabeloop Software (Model predictive control)

Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.

OTHER

Declaration of meals

Patient inputs related to meals

OTHER

No declaration of meals

No patient inputs related to meals

OTHER

Remote monitoring (Telemedicine)

Remote follow up by care health providers team

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Jacques Beltrand · Necker Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2024-02-14
Completion
2024-05-19

Countries

  • Belgium
  • France
  • Germany

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 NCT04725591 on ClinicalTrials.gov