Hybrid Closed-Loop Insulin Delivery After Pancreatectomy (HCL PP)

Centre Hospitalier Sud Francilien

Status

Enrolling

Conditions

Total Pancreatectomy

Partial Pancreatectomy

Pancreatectomy

Treatments

Device: MiniMed 780 associated with Simplera

Study type

Interventional

Funder types

Other

Identifiers

NCT07430293

2025-A02384-45

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Planned chemotherapy within the next 6 months
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