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Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Sud Francilien
NCT07430293 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 c

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age from 18 years 2. History of total or partial pancreatectomy with random C-peptide \< 0.3 ng/mL and concomitant blood glucose between 120 and 225 mg/dL (no minimum delay required since surgery) 3. Total daily insulin dose between 6 units and 250 units 4. Be affiliated to a French social security scheme 5. Individual able and willing to provide written informed consent Exclusion Criteria: 1. Presence of diabetic retinopathy at or beyond severe non-proliferative diabetic retinopathy, not stabilized by ophthalmologic treatment 2. Usual diabetes treatment with an insulin pump coupled with continuous glucose monitoring with a "suspend before hypoglycemia" system 3. Pregnant woman or planned pregnancy within the next 6 months 4. Ongoing or planned chemotherapy that interferes or is expected to interfere with glycemic control or nutritional intake, particularly in cases of clinically significant gastrointestinal toxicity and/or associated systemic corticosteroid therapy, after consultation with the treating oncologist. 5. Enteral or parenteral nutrition 6. Estimated life expectancy less than 12 months 7. Cognitive or psychiatric disorders compromising the individual's autonomy to manage automated insulin delivery 8. Person taking part in another research study or with an exclusion period still in progress 9. Individual under legal guardianship or curatorship 10. Any contraindication mentioned in the instructions for use of the MiniMed 780 - Simplera 11. Imprisoned or otherwise deprived of liberty
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What it tests

  • MiniMed 780 associated with Simplera
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Where

2 sites
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Hôpital Bichat (APHP)
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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