Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

NCT07430293 | Not Yet Recruiting

• 1 other identifier: 2025-A02384-45
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Total Pancreatectomy; Partial Pancreatectomy; Pancreatectomy

Keywords

diabetes; pancreatectomy; hybrid cloosed-loop; automatised insulin delivery

Outcome Measures

Primary Outcomes (1)

• 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.

  At 3 months

Secondary Outcomes (4)

• HbA1c

  At 3 months

• Percentage of time below range

  At 3 months

• Glucose coefficient of variation

  At 3 months

• Frequency of acute metabolic events

  At 3 months

Study Arms (2)

Sequence 1: MiniMed 780 then usual diabetes treatment

EXPERIMENTAL

Device: MiniMed 780 associated with Simplera

Sequence 2: Usual diabetes treatment then MiniMed 780

EXPERIMENTAL

Device: MiniMed 780 associated with Simplera

Interventions

MiniMed 780 associated with Simplera DEVICE

MiniMed 780 associated with Simplera

Sequence 1: MiniMed 780 then usual diabetes treatment; Sequence 2: Usual diabetes treatment then MiniMed 780

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (2)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100, France

Location

Hôpital Bichat (APHP)

Paris, France, 75018, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Coralie AMADOU, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coralie AMADOU, MD

CONTACT

1 61 69 33 87; coralie.amadou@chsf.fr

Caroline TOURTE

CONTACT

1 61 69 31 50; caroline.tourte@chsf.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FR (2)