RecruitingNot ApplicableNCT07430293

Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

Metabolic Effects of Hybrid Closed-loop Insulin Delivery in People With Diabetes After Pancreatectomy: a Randomized Cross-over Controlled Trial


Sponsor

Centre Hospitalier Sud Francilien

Enrollment

24 participants

Start Date

May 19, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called MiniMed 780 associated with Simplera for people with pancreatectomy, partial pancreatectomy, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMiniMed 780 associated with Simplera

MiniMed 780 associated with Simplera


Locations(2)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, France

Hôpital Bichat (APHP)

Paris, France, France

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NCT07430293


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