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The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas").
Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.
A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hybrid closed loop insulin delivery system | Device | Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent in the target | Percentage of time spent in the target, between 70 and 180 mg/dl: 14 to 90 days before starting hybrid closed loop | at day 0 |
| Percentage of time spent in the target | Percentage of time spent in the target, between 70 and 180 mg/dl the last 90 days available (T1) after starting hybrid closed loop | at day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent | Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range ) | at day 0 |
| Percentage of time spent | Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range ) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with secondary pancreatic diabetes and implementation of automated insulin therapy in BF
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| Name | Affiliation | Role |
|---|---|---|
| Alfred PENFORNIS, PHD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | Fra | 9110 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38788339 | Derived | Touimer M, Charfi H, Sa Cunha A, Penfornis A, Amadou C. Closed-loop insulin delivery systems in patients with pancreatitis or pancreatectomy-induced diabetes: A case series. Diabetes Metab. 2024 Jul;50(4):101544. doi: 10.1016/j.diabet.2024.101544. Epub 2024 May 24. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| at day 90 |
| Pourcentage of closed-loop mode use | Pourcentage of closed-loop mode use | at day 90 |
| Hypoglycemia events (serveral hypoglycemia ) | Number of serveral hypoglycemia events requiring hospitilisation and/or emergency | at day 0 |
| Hypoglycemia events (serveral hypoglycemia ) | Number of serveral hypoglycemia events requiring hospitilisation and/or emergency | at day 90 |
| Hyperglycemia events | Number of hyperglycemia events requiring hospitalisation and /or emergency | at day 0 |
| Hyperglycemia events | Number of hyperglycemia events requiring hospitalisation and /or emergency | at day 90 |
| Glucose Management Indicator (GMI) | Glucose Management Indicator (GMI) | at day 0 |
| Glucose Management Indicator (GMI) | Glucose Management Indicator (GMI) | at day 90 |
| Coeffecient of variabilty of Glucose Management Indicator | Coeffecient of variabilty | at day 0 |
| Coeffecient of variabilty of Glucose Management Indicator | Coeffecient of variabilty | at day 90 |
| Microangiopathic events | Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy ) | at day 0 |
| Microangiopathic events | Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy ) | at day 90 |