Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MiniMed 780 associated with Simplera.
- Who it may be relevant to
- Registry conditions: Pancreatectomy, Total Pancreatectomy, Partial Pancreatectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Metabolic Effects of Hybrid Closed-loop Insulin Delivery in People With Diabetes After Pancreatectomy: a Randomized Cross-over Controlled Trial
Overview
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.
Detailed description
The MiniMed 780G system comprises an external insulin pump with a subcutaneous infusion catheter inserted by the participant using a dedicated insertion kit. The infusion set is placed in the abdomen, buttocks, thighs, or upper arms, following standard hygiene procedures.
The Simplera system consists of an all-in-one external continuous glucose sensor inserted subcutaneously in the back of the upper arm via a dedicated insertion device.
Interventions
- Device MiniMed 780 associated with Simplera
MiniMed 780 associated with Simplera
Primary outcome measures
- Percentage of time in range [Time frame: At 3 months]
Secondary outcome measures (4)
- HbA1c [Time frame: At 3 months]
- Percentage of time below range [Time frame: At 3 months]
- Glucose coefficient of variation [Time frame: At 3 months]
- Frequency of acute metabolic events [Time frame: At 3 months]
Eligibility criteria
Inclusion criteria
- Age from 18 years
- 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)
- Total daily insulin dose between 6 units and 250 units
- Be affiliated to a French social security scheme
- Individual able and willing to provide written informed consent
Exclusion criteria
- Presence of diabetic retinopathy at or beyond severe non-proliferative diabetic retinopathy, not stabilized by ophthalmologic treatment
- Usual diabetes treatment with an insulin pump coupled with continuous glucose monitoring with a "suspend before hypoglycemia" system
- Pregnant woman or planned pregnancy within the next 6 months
- 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.
- Enteral or parenteral nutrition
- Estimated life expectancy less than 12 months
- Cognitive or psychiatric disorders compromising the individual's autonomy to manage automated insulin delivery
- Person taking part in another research study or with an exclusion period still in progress
- Individual under legal guardianship or curatorship
- Any contraindication mentioned in the instructions for use of the MiniMed 780 - Simplera
- Imprisoned or otherwise deprived of liberty
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Centre Hospitalier Sud Francilien — Corbeil-Essonnes
- Hôpital Bichat (APHP) — Paris
Identifiers
NCT: NCT07430293 · 2025-A02384-45