Diabeloop for Kids

NCT03671915 | Completed

• 1 other identifier: 2018-A02078-47
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Keywords

artificial pancreas

Outcome Measures

Primary Outcomes (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).

  Measurement of glucose by CGM

  72 hours

Secondary Outcomes (15)

• Sensor mean glucose

  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

  72 hours

• Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)

  72 hours and 6 weeks (home study phase)

• Percentage of sensor time in glucose range 70-140 mg/dl

  72 hours and 6 weeks (home study phase)

Study Arms (2)

Usual System (Open-loop)

ACTIVE COMPARATOR

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; Device: External Insulin Pump

DIABELOOP System (Closed-loop)

EXPERIMENTAL

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

Interventions

Continuous Glucose Monitoring DEVICE

collection of glucose data

DIABELOOP System (Closed-loop); Usual System (Open-loop)

External Insulin Pump DEVICE

Insulin delivery

DIABELOOP System (Closed-loop); Usual System (Open-loop)

Diabeloop Software (Model predictive control) 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.

DIABELOOP System (Closed-loop)

Remote monitoring (Telemedicine) OTHER

Remote follow up by care health providers team

DIABELOOP System (Closed-loop)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Necker Enfants Malades Hospital

Paris, 75015, France

Location

Toulouse University Hospital Center

Toulouse, 31059, France

Location

Related Publications (2)

• Benhamou PY, Adenis A, Tourki Y, Pou S, Madrolle S, Franc S, Kariyawasam D, Beltrand J, Klonoff DC, Charpentier G. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol. 2024 Mar;18(2):372-379. doi: 10.1177/19322968221128565. Epub 2022 Sep 29.

  PMID: 36172702 DERIVED

• 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.

  PMID: 35216750 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring; Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Closed loop vs. Open loop

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: May 6, 2019
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (2)