Diabeloop for Kids

Diabetes Mellitus, Type 1 Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671915
• Other study ID #: 2018-A02078-47
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: March 2020
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Continuous Glucose Monitoring
collection of glucose data
• External Insulin Pump
Insulin delivery
• 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

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
France	Necker Enfants Malades Hospital	Paris
France	Toulouse University Hospital Center	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Secondary	Coefficient of variation (SD/Mean %)		72 hours
Secondary	Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM	Measurement of glucose by CGM	72 hours
Secondary	Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Secondary	Percentage of sensor time in glucose range 70-140 mg/dl	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Secondary	Percentage time in glucose levels in the widened target range 70-180 mg/dl	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Secondary	Fasting blood glucose, mg/dl (mmol/L)		72 hours and 6 weeks
Secondary	Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl	Measurement of glucose by CGM	72 hours
Secondary	Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl	Measurement of glucose by CGM	72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Secondary	Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia	Measurement of glucose by CGM	72 hours and 6 weeks (home study phase)
Secondary	Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl	Measurement of glucose by CGM	72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Secondary	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.	72 hours and 6 weeks (home study phase)
Secondary	Percentage of time closed-loop active		72 hours and 6 weeks (home study phase)
Secondary	Total daily dose of insulin	Total basal and bolus by 24h	72 hours and 6 weeks (home study phase)
Secondary	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.	72 hours and 6 weeks (home study phase)