Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who have had partial or total pancreatectomy and diabetes will use a 3-month hybrid closed-loop automated insulin delivery system combining MiniMed 780G with Simplera CGM. The trial uses a real-world approach with commercially available devices to see if automated insulin delivery improves glucose control and quality of life compared to usual care. Participants must have residual insulin dependence, specific glucose ranges, and meet residency/insurance criteria in France. Outcomes will focus on glycemic metrics, safety, and patient-reported experience. The study is grounded in prior observational data and one randomized trial suggesting potential benefits with monohormonal systems, aiming to confirm applicability in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Hospitalier Sud Francilien
  Corbeil-Essonnes, France, France Recruiting
• Hôpital Bichat (APHP)
  Paris, France, France Not yet recruiting

Study contacts

• Principal investigator: Coralie AMADOU, MD — Centre Hospitalier Sud Francilien
• Study coordinator: Coralie AMADOU, MD
• Email: coralie.amadou@chsf.fr
• Phone: 1 61 69 33 87

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.