Diabeloop for Kids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2019-12-23

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Closed loop vs. Open loop

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual System (Open-loop)

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

Group Type ACTIVE_COMPARATOR

Continuous Glucose Monitoring

Intervention Type DEVICE

collection of glucose data

External Insulin Pump

Intervention Type DEVICE

Insulin delivery

DIABELOOP System (Closed-loop)

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.

Group Type EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type DEVICE

collection of glucose data

External Insulin Pump

Intervention Type DEVICE

Insulin delivery

Diabeloop Software (Model predictive control)

Intervention Type DEVICE

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.

Remote monitoring (Telemedicine)

Intervention Type OTHER

Remote follow up by care health providers team

Interventions

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Continuous Glucose Monitoring

collection of glucose data

Intervention Type DEVICE

External Insulin Pump

Insulin delivery

Intervention Type 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.

Intervention Type DEVICE

Remote monitoring (Telemedicine)

Remote follow up by care health providers team

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No