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Completed

NCT Number: NCT03671915

Diabeloop for Kids

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.

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Key information

Conditions

Closed Loop Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Young Children (6 to 12 Years Old )

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous glucose monitoring

Device

collection of glucose data

External Insulin Pump

Device

Insulin delivery

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.

Remote monitoring (Telemedicine)

Other

Remote follow up by care health providers team

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).

    Time frame: 72 hours

    Measurement of glucose by CGM

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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.

Acronym: DBL4K

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2018
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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