Diabeloop for Kids (DBL4K)

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

Status: Completed

Conditions: Young Children (6 to 12 Years Old ); Diabetes Mellitus, Type 1; Closed Loop

Treatments: Other: Remote monitoring (Telemedicine); Device: Continuous Glucose Monitoring; Device: External Insulin Pump; Device: Diabeloop Software (Model predictive control)

Study type: Interventional

Funder types: Other

Identifiers

NCT03671915

2018-A02078-47

Details and patient eligibility

About

An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up home study phase, crossover study comparing Diabeloop closed-loop (CL) system and sensor-augmented pump (SAP) therapy.

The follow-up home study phase will be done only in French centers for a sub study. During this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote monitoring follow-up by specialized nurses, under supervision of a diabetologist. A visualization of glucose CGM curves, insulin delivery, meal and physical activity announcements will be available online through secured website, and the system will send automated message in case of predetermined situations as persistent too high or too low Blood Glucose (BG). Custom settings will be possible by the nurses during the follow-up period.

Enrollment: 21 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prepubescent children (Gender: both) aged between 6 to 12 years old (Tanner stage 1) at time of screening
• Type 1 diabetes as defined by WHO for at least 1 year or confirmed C peptide negative
• An insulin pump user for at least 3 months.
• Subject having a Glycosylated hemoglobin (HbA1c) blood value < 9% at time of screening visit-based on analysis from local laboratory within 3 months.
• Subject having a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
• Subject and his parent/guardian willing to spend 3-overnight in hospital.
• Subject willing to wear the system continuously throughout the study
• Subjects and his parent/guardian must be able to speak and be literate in French or Flemish as verified by the investigator

Exclusion criteria

• Children who are in pubertal stage
• Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: - Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) - Coma - Seizures
• Subject having sever DKA in the 6 months prior to screening visit.
• Known or suspected allergy against insulin
• Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.
• Subject is unable to tolerate tape adhesive around the sensor or pump placements
• Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
• Subject having took any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Usual System (Open-loop)

Active Comparator group

Description:

In open loop: sensor-augmented pump (SAP) therapy using standard insulin pump setting combined with the six-generation glucose sensor (Dexcom G6).

Treatment:

Device: Continuous Glucose Monitoring

Device: External Insulin Pump

DIABELOOP System (Closed-loop)

Experimental group

Description:

In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump. A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session.

Treatment:

Other: Remote monitoring (Telemedicine)

Device: Continuous Glucose Monitoring

Device: Diabeloop Software (Model predictive control)

Device: External Insulin Pump