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Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

NCT07430293 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-28

No results posted yet for this study

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.

Conditions

  • Pancreatectomy
  • Total Pancreatectomy
  • Partial Pancreatectomy

Interventions

DEVICE

MiniMed 780 associated with Simplera

MiniMed 780 associated with Simplera

Sponsors & Collaborators

  • Centre Hospitalier Sud Francilien

    lead OTHER

Principal Investigators

  • Coralie AMADOU, MD · Centre Hospitalier Sud Francilien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-19
Primary Completion
2027-11-19
Completion
2027-11-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430293 on ClinicalTrials.gov