Diabeloop for Kids (DBL4K)

• ClinicalTrials.gov Identifier: NCT03671915
• Recruitment Status: Completed
• First Posted: September 14, 2018
• Last Update Posted: March 6, 2020
• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Information provided by (Responsible Party): Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Closed Loop; Diabetes Mellitus, Type 1; Young Children (6 to 12 Years Old )	Device: Continuous Glucose Monitoring; Device: External Insulin Pump; Device: Diabeloop Software (Model predictive control); Other: Remote monitoring (Telemedicine)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Closed loop vs. Open loop
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: May 6, 2019
• Actual Primary Completion Date: December 23, 2019
• Actual Study Completion Date: December 23, 2019

Arms and Interventions

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: Continuous Glucose Monitoring; collection of glucose data; Device: 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: Remote monitoring (Telemedicine); Remote follow up by care health providers team

Outcome Measures

Primary Outcome Measures :

1. 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). [ Time Frame: 72 hours ]
   Measurement of glucose by CGM

Secondary Outcome Measures :

1. Sensor mean glucose [ Time Frame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) ]
   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
2. Coefficient of variation (SD/Mean %) [ Time Frame: 72 hours ]
3. Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM [ Time Frame: 72 hours ]
   Measurement of glucose by CGM
4. Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI) [ Time Frame: 72 hours and 6 weeks (home study phase) ]
   Measurement of glucose by CGM
5. Percentage of sensor time in glucose range 70-140 mg/dl [ Time Frame: 72 hours and 6 weeks (home study phase) ]
   Measurement of glucose by CGM
6. Percentage time in glucose levels in the widened target range 70-180 mg/dl [ Time Frame: 72 hours and 6 weeks (home study phase) ]
   Measurement of glucose by CGM
7. Fasting blood glucose, mg/dl (mmol/L) [ Time Frame: 72 hours and 6 weeks ]
8. Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl [ Time Frame: 72 hours ]
   Measurement of glucose by CGM
9. Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl [ Time Frame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) ]
   Measurement of glucose by CGM
10. Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia [ Time Frame: 72 hours and 6 weeks (home study phase) ]
    Measurement of glucose by CGM
11. Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl [ Time Frame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) ]
    Measurement of glucose by CGM
12. Severe Diabetic Ketoacidosis (DKA) events [ Time Frame: 72 hours and 6 weeks (home study phase) ]
    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.
13. Percentage of time closed-loop active [ Time Frame: 72 hours and 6 weeks (home study phase) ]
14. Total daily dose of insulin [ Time Frame: 72 hours and 6 weeks (home study phase) ]
    Total basal and bolus by 24h
15. Subject's perception in terms of life-style change, satisfaction and diabetes management [ Time Frame: 72 hours and 6 weeks (home study phase) ]
    Subject's perception in terms of life-style change, satisfaction and diabetes management as evaluated by PedsQL, DTQ, DTSQ and AP acceptance questionnaire.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Belgium

University Hospitals Leuven

Leuven, Belgium, 3000

France

Necker Enfants Malades Hospital

Paris, France, 75015

Toulouse University Hospital Center

Toulouse, France, 31059

Sponsors and Collaborators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• ClinicalTrials.gov Identifier: NCT03671915
• Other Study ID Numbers: 2018-A02078-47
• First Posted: September 14, 2018
• Last Update Posted: March 6, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète:

artificial pancreas

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs