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Diabeloop for Kids (DBL4K)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Continuous Glucose Monitoring
External Insulin Pump
Diabeloop Software (Model predictive control)
Remote monitoring (Telemedicine)
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Loop focused on measuring artificial pancreas

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Leuven
  • Necker Enfants Malades Hospital
  • Toulouse University Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual System (Open-loop)

DIABELOOP System (Closed-loop)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Coefficient of variation (SD/Mean %)
Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM
Measurement of glucose by CGM
Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)
Measurement of glucose by CGM
Percentage of sensor time in glucose range 70-140 mg/dl
Measurement of glucose by CGM
Percentage time in glucose levels in the widened target range 70-180 mg/dl
Measurement of glucose by CGM
Fasting blood glucose, mg/dl (mmol/L)
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl
Measurement of glucose by CGM
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl
Measurement of glucose by CGM
Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia
Measurement of glucose by CGM
Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl
Measurement of glucose by CGM
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.
Percentage of time closed-loop active
Total daily dose of insulin
Total basal and bolus by 24h
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.

Full Information

First Posted
September 13, 2018
Last Updated
March 5, 2020
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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1. Study Identification

Unique Protocol Identification Number
NCT03671915
Brief Title
Diabeloop for Kids
Acronym
DBL4K
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Loop, Diabetes Mellitus, Type 1, Young Children (6 to 12 Years Old )
Keywords
artificial pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Closed loop vs. Open loop
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual System (Open-loop)
Arm Type
Active Comparator
Arm Description
In open loop: sensor-augmented pump (SAP) therapy using standard insulin pump setting combined with the six-generation glucose sensor (Dexcom G6).
Arm Title
DIABELOOP System (Closed-loop)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Description
collection of glucose data
Intervention Type
Device
Intervention Name(s)
External Insulin Pump
Intervention Description
Insulin delivery
Intervention Type
Device
Intervention Name(s)
Diabeloop Software (Model predictive control)
Intervention Description
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
Other
Intervention Name(s)
Remote monitoring (Telemedicine)
Intervention Description
Remote follow up by care health providers team
Primary Outcome Measure Information:
Title
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).
Description
Measurement of glucose by CGM
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Sensor mean glucose
Description
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
Time Frame
72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Title
Coefficient of variation (SD/Mean %)
Time Frame
72 hours
Title
Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM
Description
Measurement of glucose by CGM
Time Frame
72 hours
Title
Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)
Description
Measurement of glucose by CGM
Time Frame
72 hours and 6 weeks (home study phase)
Title
Percentage of sensor time in glucose range 70-140 mg/dl
Description
Measurement of glucose by CGM
Time Frame
72 hours and 6 weeks (home study phase)
Title
Percentage time in glucose levels in the widened target range 70-180 mg/dl
Description
Measurement of glucose by CGM
Time Frame
72 hours and 6 weeks (home study phase)
Title
Fasting blood glucose, mg/dl (mmol/L)
Time Frame
72 hours and 6 weeks
Title
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl
Description
Measurement of glucose by CGM
Time Frame
72 hours
Title
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl
Description
Measurement of glucose by CGM
Time Frame
72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Title
Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia
Description
Measurement of glucose by CGM
Time Frame
72 hours and 6 weeks (home study phase)
Title
Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl
Description
Measurement of glucose by CGM
Time Frame
72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Title
Severe Diabetic Ketoacidosis (DKA) events
Description
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.
Time Frame
72 hours and 6 weeks (home study phase)
Title
Percentage of time closed-loop active
Time Frame
72 hours and 6 weeks (home study phase)
Title
Total daily dose of insulin
Description
Total basal and bolus by 24h
Time Frame
72 hours and 6 weeks (home study phase)
Title
Subject's perception in terms of life-style change, satisfaction and diabetes management
Description
Subject's perception in terms of life-style change, satisfaction and diabetes management as evaluated by PedsQL, DTQ, DTSQ and AP acceptance questionnaire.
Time Frame
72 hours and 6 weeks (home study phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Necker Enfants Malades Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Toulouse University Hospital Center
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35216750
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.
Results Reference
derived

Learn more about this trial

Diabeloop for Kids

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