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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | collection of glucose data |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Coefficient of variation (SD/Mean %) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium | |||
| Necker Enfants Malades Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36172702 | Derived | 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. | |
| 35216750 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Closed loop vs. Open loop
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| 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 |
|
| 72 hours |
| Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM | Measurement of glucose by CGM | 72 hours |
| Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI) | Measurement of glucose by CGM | 72 hours and 6 weeks (home study phase) |
| Percentage of sensor time in glucose range 70-140 mg/dl | Measurement of glucose by CGM | 72 hours and 6 weeks (home study phase) |
| 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) |
| 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 | Measurement of glucose by CGM | 72 hours |
| 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) |
| 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) |
| 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) |
| 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) |
| Percentage of time closed-loop active | 72 hours and 6 weeks (home study phase) |
| Total daily dose of insulin | Total basal and bolus by 24h | 72 hours and 6 weeks (home study phase) |
| 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) |
| Paris |
| 75015 |
| France |
| Toulouse University Hospital Center | Toulouse | 31059 | France |
| 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |