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Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

Study acronym: HCL PP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 29 wordsv3
  2. Recruitment opened
    • Primary and study completion pushed from Sep 1, 2027 to Nov 19, 2027
    • Start date changed from estimate of Mar 1, 2026 to May 19, 2026
    • Site details revised at 2 of 2 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07430293
Lead Sponsor Centre Hospitalier Sud Francilien
Conditions
(from sponsor)		 Pancreatectomy, Total Pancreatectomy, Partial Pancreatectomy
Related terms Diabetes Mellitus
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov