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

Metabolic Effects of Hybrid Closed-loop Insulin Delivery in People With Diabetes After Pancreatectomy: a Randomized Cross-over Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatectomy; Total Pancreatectomy; Partial Pancreatectomy
• Intervention / Treatment: Device: MiniMed 780 associated with Simplera

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Coralie AMADOU, MD; Phone Number: +33 1 61 69 33 87; Email: coralie.amadou@chsf.fr
• Study Contact Backup: Name: Caroline TOURTE; Phone Number: +33 1 61 69 31 50; Email: caroline.tourte@chsf.fr

Study Locations

• France
  • France
    • Corbeil-Essonnes, France, France, 91100
      • Recruiting
      • Centre Hospitalier Sud Francilien
      • Contact: Coralie AMADOU, MD; Phone Number: +33 1 61 69 33 87; Email: coralie.amadou@chsf.fr
      • Principal Investigator: Coralie AMADOU, MD
    • Paris, France, France, 75018
      • Not yet recruiting
      • Hôpital Bichat (APHP)
      • Contact: Aurélie CARLIER, MD; Phone Number: +33 1 40 25 78 67; Email: aurelie.carlier@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age from 18 years
2. 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)
3. Total daily insulin dose between 6 units and 250 units
4. Be affiliated to a French social security scheme
5. Individual able and willing to provide written informed consent

Exclusion Criteria:

1. Presence of diabetic retinopathy at or beyond severe non-proliferative diabetic retinopathy, not stabilized by ophthalmologic treatment
2. Usual diabetes treatment with an insulin pump coupled with continuous glucose monitoring with a "suspend before hypoglycemia" system
3. Pregnant woman or planned pregnancy within the next 6 months
4. Planned chemotherapy within the next 6 months
5. Enteral or parenteral nutrition
6. Estimated life expectancy less than 12 months
7. Cognitive or psychiatric disorders compromising the individual's autonomy to manage automated insulin delivery
8. Person taking part in another research study or with an exclusion period still in progress
9. Individual under legal guardianship or curatorship
10. Any contraindication mentioned in the instructions for use of the MiniMed 780 - Simplera
11. Imprisoned or otherwise deprived of liberty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: MiniMed 780 then usual diabetes treatment	Device: MiniMed 780 associated with Simplera; MiniMed 780 associated with Simplera
Experimental: Sequence 2: Usual diabetes treatment then MiniMed 780	Device: MiniMed 780 associated with Simplera; MiniMed 780 associated with Simplera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At 3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Coralie AMADOU, MD, Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): November 19, 2027
• Study Completion (Estimated): November 19, 2027

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; pancreatectomy; hybrid cloosed-loop; automatised insulin delivery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2025-A02384-45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No