Closed Loop, Diabetes Mellitus, Type 1, Young Children (6 to 12 Years Old )
Conditions
Keywords
artificial pancreas
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.
Interventions
DEVICEContinuous Glucose Monitoring
collection of glucose data
DEVICEExternal Insulin Pump
Insulin delivery
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 follow up by care health providers team
Sponsors
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Closed loop vs. Open loop
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 72 hours | Measurement of glucose by CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI) | 72 hours and 6 weeks (home study phase) | Measurement of glucose by CGM |
| Sensor mean glucose | 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 |
| Coefficient of variation (SD/Mean %) | 72 hours | — |
| Percentage of sensor time in glucose range 70-140 mg/dl | 72 hours and 6 weeks (home study phase) | Measurement of glucose by CGM |
| Percentage time in glucose levels in the widened target range 70-180 mg/dl | 72 hours and 6 weeks (home study phase) | Measurement of glucose by CGM |
| Fasting blood glucose, mg/dl (mmol/L) | 72 hours and 6 weeks | — |
| Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl | 72 hours | Measurement of glucose by CGM |
| Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM | 72 hours | Measurement of glucose by CGM |
| Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia | 72 hours and 6 weeks (home study phase) | Measurement of glucose by CGM |
| Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl | 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) | Measurement of glucose by CGM |
| Severe Diabetic Ketoacidosis (DKA) events | 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. |
| Percentage of time closed-loop active | 72 hours and 6 weeks (home study phase) | — |
| Total daily dose of insulin | 72 hours and 6 weeks (home study phase) | Total basal and bolus by 24h |
| Subject's perception in terms of life-style change, satisfaction and diabetes management | 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. |
| Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl | 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase) | Measurement of glucose by CGM |
Countries
Belgium, France
Outcome results
None listed