Clinical trial NCT03671915: Diabeloop for Kids
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Loop
Diabetes Mellitus, Type 1
Young Children (6 to 12 Years Old )
Keywords: artificial pancreas
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Closed loop vs. Open loop
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 72 hours
Secondary outcomes:
measure: Sensor mean glucose
timeFrame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
measure: Coefficient of variation (SD/Mean %)
timeFrame: 72 hours
measure: Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM
timeFrame: 72 hours
measure: Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)
timeFrame: 72 hours and 6 weeks (home study phase)
measure: Percentage of sensor time in glucose range 70-140 mg/dl
timeFrame: 72 hours and 6 weeks (home study phase)
measure: Percentage time in glucose levels in the widened target range 70-180 mg/dl
timeFrame: 72 hours and 6 weeks (home study phase)
measure: Fasting blood glucose, mg/dl (mmol/L)
timeFrame: 72 hours and 6 weeks
measure: Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl
timeFrame: 72 hours
measure: Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl
timeFrame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
measure: Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia
timeFrame: 72 hours and 6 weeks (home study phase)
measure: Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl
timeFrame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
measure: Severe Diabetic Ketoacidosis (DKA) events
timeFrame: 72 hours and 6 weeks (home study phase)
measure: Percentage of time closed-loop active
timeFrame: 72 hours and 6 weeks (home study phase)
measure: Total daily dose of insulin
timeFrame: 72 hours and 6 weeks (home study phase)
measure: Subject's perception in terms of life-style change, satisfaction and diabetes management
timeFrame: 72 hours and 6 weeks (home study phase)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Paris
country: France
facility: Necker Enfants Malades Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital Center
Study officials:
References:
citation: 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.