An interventional study of MiniMed 780 associated with Simplera in Pancreatectomy, Total Pancreatectomy and Partial Pancreatectomy, sponsored by Centre Hospitalier Sud Francilien. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Centre Hospitalier Sud Francilien · Not applicable, Interventional, and Treatment
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 24 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Centre Hospitalier Sud Francilien is the lead sponsor of 58 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: MiniMed 780 associated with Simplera
Device: MiniMed 780 associated with Simplera
MiniMed 780 associated with Simplera
Percentage of time in range
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 with participant's usual diabetes treatment.
Time frame: At 3 months
HbA1c
HbA1c level, measured by laboratory blood testing, after 3 months of treatment with MiniMed 780 compared to after 3 months of the participant's usual diabetes treatment.
Time frame: At 3 months
Percentage of time below range
The percentage of time that interstitial glucose levels remain below 70 mg/dL, as measured by CGM, over a 3-month period using MiniMed 780, compared to a 3-month period under the participant's usual diabetes treatment.
Time frame: At 3 months
Glucose coefficient of variation
The glucose coefficient of variation (CV), as measured by CGM, over a 3-month period using MiniMed 780 hybrid closed-loop system, compared to a 3-month period under the participant's usual diabetes treatment.
Time frame: At 3 months
Frequency of acute metabolic events
The frequency of severe acute metabolic events combining frequency of severe hypoglycemia, diabetic ketoacidosis (DKA), and diabetes-related emergency visit or unplanned hospitalisation, over a 3-month period using MiniMed 780 hybrid closed-loop system, compared to a 3-month period under the participant's usual diabetes treatment.
Time frame: At 3 months
Started May 2026 (actual). Primary completion is estimated for Nov 2027, 18 months after the start.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 18 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Sud Francilien