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| ID | Type | Description | Link |
|---|---|---|---|
| 35RC13_8806_PPA | Other Identifier | Rennes University Hospital |
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The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)
Ten patients will be assessed during a closed-loop night and an open-loop night in random order.
The primary objective is to assess the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-loop night | Active Comparator |
| |
| closed-loop night | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open-loop night | Other | During the open-loop night the patient is using his insulin pump as usual |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of time spent in target range (glycemia between 70 and 145 mg/dl) and in hypoglycemia (glycemia <70 mg/dl), during the night (11 PM to 8 AM) | Assessment of the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of time spent above 70 mg/dl, between 70-145 or 145-180 mg/dl and above 180 mg/dl (interstitial glucose) in the late post prandial period (9 to 11 PM) and during the night (11 PM to 8 AM) | Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Guilhem | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28677416 | Result | Guilhem I, Penet M, Paillard A, Carpentier M, Esvant A, Lefebvre MA, Poirier JY. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study. J Diabetes Sci Technol. 2017 Sep;11(5):1007-1014. doi: 10.1177/1932296817717503. Epub 2017 Jul 5. |
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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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| closed-loop night | Other | During the closed-loop night glucose values measured by the sensor are collected every 15 minutes. The data are entered into the SP-MPC controler that calculate the insulin dose to be delivered. A diabetologist validates the insulin dose before the infusion (manually bolus infusion) |
|
| Assessment of hypoglycemia occurrence during the night |
| 6 weeks |
| Assessment of area under the curves (70-180mg/dl) during the night | 6 weeks |
| Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index | 6 weeks |
| Assessment of insulin doses delivered between 9 PM and 8 AM | 6 weeks |
| Assessment of number of controller propositions rejected for security reasons | 6 weeks |
| Assessment of glucose values during the night (glycemia and interstitial glucose values) | 6 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |