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Individuals with diabetes secondary to pancreatectomy experience impaired quality of life, partly due to the challenges of managing highly variable blood glucose levels. Hybrid closed-loop (HCL) automated insulin delivery (AID) systems, widely evaluated in type 1 diabetes, may improve both metabolic outcomes and quality of life in this population.
A review of the literature identified a few observational studies reporting promising results with HCL systems in the context of post-pancreatectomy diabetes. Only one randomized trial has evaluated AID in this population, showing excellent outcomes, but using a complex bihormonal system that is not yet commercially available worldwide. Consequently, there remains a lack of confirmatory evidence regarding the efficacy of commercially available monohormonal HCL systems in individuals with diabetes secondary to pancreatectomy, evidence that is crucial to support broader access to this technology.
The intervention will consist in a 3-month AID treatment combining MiniMed 780 and Simplera.
The control period will consist in 3 months using the Simplera for continuous glucose monitoring, alongside participant usual diabetes treatment.
The primary outcome is the percentage of time that interstitial glucose levels remain within the target range (70-180 mg/dL), as measured by continuous glucose monitoring (CGM, Simplera), over a 3-month period using the MiniMed 780 hybrid closed-loop system, compared to a 3-month period under the participant's usual diabetes treatment.
The MiniMed 780G system comprises an external insulin pump with a subcutaneous infusion catheter inserted by the participant using a dedicated insertion kit. The infusion set is placed in the abdomen, buttocks, thighs, or upper arms, following standard hygiene procedures.
The Simplera system consists of an all-in-one external continuous glucose sensor inserted subcutaneously in the back of the upper arm via a dedicated insertion device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: MiniMed 780 then usual diabetes treatment | Experimental |
| |
| Sequence 2: Usual diabetes treatment then MiniMed 780 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed 780 associated with Simplera | Device | MiniMed 780 associated with Simplera |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in range | Percentage of time that interstitial glucose levels remain within the target range (70-180 mg/dL), as measured by continuous glucose monitoring (CGM, Simplera), over a 3-month period using the MiniMed 780 hybrid closed-loop system compared to a 3-month period with participant's usual diabetes treatment. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c level, measured by laboratory blood testing, after 3 months of treatment with MiniMed 780 compared to after 3 months of the participant's usual diabetes treatment. | At 3 months |
| Percentage of time below range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Coralie AMADOU, MD | Contact | 1 61 69 33 87 | +33 | coralie.amadou@chsf.fr |
| Caroline TOURTE | Contact | 1 61 69 31 50 | +33 | caroline.tourte@chsf.fr |
| Name | Affiliation | Role |
|---|---|---|
| Coralie AMADOU, MD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Recruiting | Corbeil-Essonnes | France | 91100 | France |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The percentage of time that interstitial glucose levels remain below 70 mg/dL, as measured by CGM, over a 3-month period using MiniMed 780, compared to a 3-month period under the participant's usual diabetes treatment.
| At 3 months |
| Glucose coefficient of variation | The glucose coefficient of variation (CV), as measured by CGM, over a 3-month period using MiniMed 780 hybrid closed-loop system, compared to a 3-month period under the participant's usual diabetes treatment. | At 3 months |
| Frequency of acute metabolic events | The frequency of severe acute metabolic events combining frequency of severe hypoglycemia, diabetic ketoacidosis (DKA), and diabetes-related emergency visit or unplanned hospitalisation, over a 3-month period using MiniMed 780 hybrid closed-loop system, compared to a 3-month period under the participant's usual diabetes treatment. | At 3 months |
| Hôpital Bichat (APHP) | Not yet recruiting | Paris | France | 75018 | France |
|