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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB : 2011-A001212-39 | Other Identifier | Afssaps |
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The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.
During this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system.
The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and for management of the basal insulin needs. Patients will come for two closed-loop admissions of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetic population | Experimental | The only one arm (type 1 diabetic patients treated by basal-bolus insulin and external pumps) of this study will test an artificial pancreas system that uses the intraperitoneal route to deliver insulin (through DiaPort). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Pancreas for DiaPort system with Zone-MPC algorithm | Device | Artificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl) | Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl):
| in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and standard deviation blood glucose | All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days. | For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal) |
| Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric ER RENARD, MD, PU-PH | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Montpellier | 34000 | France |
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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 |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days. |
| during the 2 hospitalisations period when loop is closed (for a total of 24 hours) |
| Percentage of time spent in hyperglycemia |
| in the early postprandial period (first 4 hours after meal) and in the basal or late postprandial period (from 8 hours after meal until next meal) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |