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NCT Number: NCT07430293

Hybrid Closed-Loop Insulin Delivery After Pancreatectomy

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.

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Key information

Conditions

Pancreatectomy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Partial Pancreatectomy Total Pancreatectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MiniMed 780 associated with Simplera

Device

MiniMed 780 associated with Simplera

Primary outcomes

  1. Percentage of time in range

    Time frame: At 3 months

    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.

Secondary outcomes

  1. HbA1c

    Time frame: At 3 months

    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.

  2. Percentage of time below range

    Time frame: At 3 months

    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.

  3. Glucose coefficient of variation

    Time frame: At 3 months

    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.

  4. Frequency of acute metabolic events

    Time frame: At 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline TOURTE

CONTACT

[email protected]

1 61 69 31 50 ext. +33

Coralie AMADOU, MD

CONTACT

[email protected]

1 61 69 33 87 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: HCL PP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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