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The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.
The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM). During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period). At the end of this period, the patient and the relative will be admitted in a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first interventional session. Admission will be at 17:00 Day 1. The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated. Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e. insulin doses will be decided according to capillary glucose measurements. From 08:00 Day 2, one algorithm will be activated according to the randomization order, i.e. either the threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the closed-loop algorithm. Insulin delivery will then be managed in open-loop mode with activated TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free content and taken around 09:00, 13:00, 17:00 and 20:00. Meal insulin doses will be managed according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or according to DiAs bolus calculator suggestion in closed-loop mode. Patient and relative will be encouraged to move in parents'house or hotel/resort and surroundings between meals. The algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by patient's usual pump. The patient and the relative will be released at 10:00 after breakfast. Study CGM will still be used at home for 2 to 4 weeks until the second interventional session. This session will be similar to the first one but the alternative algorithm will be activated. Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be released at 10:00 when second session is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-to-Range algorithm and Threshold Low Glucose Suspend | Experimental | On this arm, patients will realize two investigational sessions:
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| Threshold Low Glucose Suspend and Control-to-Range algorithm | Experimental | On this arm, patients will realize two investigational sessions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm | Device | The insuline used is usual patient insuline. There is no specific insulin for this protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent with blood glucose <70 mg/dl | from 22:00 to 08:00, over two consecutive nights |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time spent with blood glucose <70mg/dl | over two consecutive days (48h) | |
| Percent time spent with blood glucose level in 70-180 mg/dl range | from 22:00 to 08:00 over two consecutive nights |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49000 | France | |||
| CHU Montpellier - Hôpital Lapeyronie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30047223 | Derived | Renard E, Tubiana-Rufi N, Bonnemaison-Gilbert E, Coutant R, Dalla-Vale F, Farret A, Poidvin A, Bouhours-Nouet N, Abettan C, Storey-London C, Donzeau A, Place J, Breton MD. Closed-loop driven by control-to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type 1 diabetes in a supervised hotel setting. Diabetes Obes Metab. 2019 Jan;21(1):183-187. doi: 10.1111/dom.13482. Epub 2018 Aug 21. |
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| Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend | Device | The insuline used is usual patient insuline. There is no specific insulin for this protocol |
|
| Percent time spent with blood glucose level in 80-150 mg/dl range | from 22:00 to 08:00 over two consecutive nights |
| Percent time spent with blood glucose level in 70-180 mg/dl range | over two consecutive days (48h) |
| Mean blood glucose level | from 22:00 to 08:00, over two consecutive nights |
| Mean blood glucose level | over two consecutive days (48h) |
| Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia | during 65 hours of each investigational session |
| Number of needed interventions by the patients, the parents, and by the investigational team, to fix issues related to the functioning of the insulin delivery system | during 65 hours of each investigational session |
| Score of the Artificial Pancreas Acceptance Questionnaire | at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4) |
| Score of the Hypo Fear Survey | at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4) |
| Montpellier |
| 34985 |
| France |
| AP-HP, Hôpital Robert Debré | Paris | 75019 | France |
| CHU de Tours, Hôpital Clocheville | Tours | 37000 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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