NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
| NCT ID | NCT07430293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Sud Francilien |
| Condition | Pancreatectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2027-11-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-05-19 with a primary completion date of 2027-11-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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. Planned chemotherapy within the next 6 months 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
Contact & Investigator
Coralie AMADOU, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Sud Francilien
Frequently Asked Questions
Who can join the NCT07430293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07430293 currently recruiting?
Yes, NCT07430293 is actively recruiting participants. Contact the research team at coralie.amadou@chsf.fr for enrollment information.
Where is the NCT07430293 trial being conducted?
This trial is being conducted at Corbeil-Essonnes, France, Paris, France.
Who is sponsoring the NCT07430293 clinical trial?
NCT07430293 is sponsored by Centre Hospitalier Sud Francilien. The principal investigator is Coralie AMADOU, MD at Centre Hospitalier Sud Francilien. The trial plans to enroll 24 participants.