Diabeloop for Kids (DBL4K)

An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Control Compared With Sensor-augmented Pump Therapy, in Young Children With Type 1 Diabetes.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Closed Loop; Young Children (6 to 12 Years Old )
• Intervention / Treatment: Device: Diabeloop Software (Model predictive control); Other: Remote monitoring (Telemedicine); Device: Continuous Glucose Monitoring; Device: External Insulin Pump

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
• France
  • Paris, France, 75015
    • Necker Enfants malades hospital
  • Toulouse, France, 31059
    • Toulouse University Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Device: Continuous Glucose Monitoring; collection of glucose data; Device: External Insulin Pump; Insulin delivery
EXPERIMENTAL: 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.	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: Remote monitoring (Telemedicine); Remote follow up by care health providers team; Device: Continuous Glucose Monitoring; collection of glucose data; Device: External Insulin Pump; Insulin delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time spent of the glucose level drop in below 70 mg/dl over the 72-h, as recorded by continuous subcutaneous glucose monitoring (CGM).	Measurement of glucose by CGM	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor mean glucose	Sensor mean glucose over the 72-h, in the overnight (defined as 23:00 to 07:00) and during the home study phase for the French centers, in closed-loop and open-loop session	72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Coefficient of variation (SD/Mean %)		72 hours
Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM	Measurement of glucose by CGM	72 hours
Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Percentage of sensor time in glucose range 70-140 mg/dl	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Percentage time in glucose levels in the widened target range 70-180 mg/dl	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Fasting blood glucose, mg/dl (mmol/L)		72 hours and 6 weeks
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl	Measurement of glucose by CGM	72 hours
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl	Measurement of glucose by CGM	72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl	Measurement of glucose by CGM	72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Severe Diabetic Ketoacidosis (DKA) events	Subjects will be asked to measure blood urine ketone levels on waking in the morning if their finger-stick glucose is above 200 mg/l, as part of the safety evaluation for hyperglycemia.	72 hours and 6 weeks (home study phase)
Percentage of time closed-loop active		72 hours and 6 weeks (home study phase)
Total daily dose of insulin	Total basal and bolus by 24h	72 hours and 6 weeks (home study phase)
Subject's perception in terms of life-style change, satisfaction and diabetes management	Subject's perception in terms of life-style change, satisfaction and diabetes management as evaluated by PedsQL, DTQ, DTSQ and AP acceptance questionnaire.	72 hours and 6 weeks (home study phase)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Kariyawasam D, Morin C, Casteels K, Le Tallec C, Sfez A, Godot C, Huneker E, Garrec N, Benhamou PY, Polak M, Charpentier G, Franc S, Beltrand J. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6-12 years: a randomised, controlled, cross-over, non-inferiority trial. Lancet Digit Health. 2022 Mar;4(3):e158-e168. doi: 10.1016/S2589-7500(21)00271-5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2019
• Primary Completion (ACTUAL): December 23, 2019
• Study Completion (ACTUAL): December 23, 2019

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: artificial pancreas
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2018-A02078-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No