PancreatectomyHCL PPNCT07430293
Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
A study testing MiniMed 780 associated with Simplera in people with Pancreatectomy and Total Pancreatectomy, run by Centre Hospitalier Sud Francilien at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy, Total Pancreatectomy, Partial Pancreatectomy
- What is being tested?
- MiniMed 780 associated with Simplera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 19 May 2026to 19 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Ongoing or planned chemotherapy that interferes or is expected to interfere with glycemic control or nutritional intake, particularly in cases of clinically significant gastrointestinal toxicity and/or associated systemic corticosteroid therapy, after consultation with the treating oncologist.
- Enteral or parenteral nutrition
- Estimated life expectancy less than 12 months
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Coralie AMADOU, MD, 1 61 69 33 87 ext. +33, coralie.amadou@chsf.fr
Coralie AMADOU, MD
- Not yet recruiting
Hôpital Bichat (APHP)
Paris, France, 75018
Aurélie CARLIER, MD, 1 40 25 78 67 ext. +33, aurelie.carlier@aphp.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pancreatectomy, Total Pancreatectomy, Partial Pancreatectomy
- Being tested
- MiniMed 780 associated with Simplera
- Keywords
- diabetes, pancreatectomy, hybrid cloosed-loop, automatised insulin delivery
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniMed 780 associated with SimpleraDevice
MiniMed 780 associated with Simplera
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: MiniMed 780 then usual diabetes treatment | Experimental | Not described Receives: Device: MiniMed 780 associated with Simplera |
| Sequence 2: Usual diabetes treatment then MiniMed 780 | Experimental | Not described Receives: Device: MiniMed 780 associated with Simplera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start19 May 2026
- Primary completion19 Nov 2027 (estimated)
- Study completion19 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coralie AMADOU, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430293
- Sponsor's protocol ID
- 2025-A02384-45
- Acronym
- HCL PP
- Status last verified
- May 2026
- First submitted
- 18 Feb 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Hybrid Closed-loop Insulin Delivery in People With Diabetes After Pancreatectomy: a Randomized Cross-over Controlled Trial
- ClinicalTrials.gov ID
- NCT07430293
- Acronym / sponsor ID
- HCL PP / 2025-A02384-45
- Conditions
- Pancreatectomy, Total Pancreatectomy, Partial Pancreatectomy
- Keywords
- diabetes, pancreatectomy, hybrid cloosed-loop, automatised insulin delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 19 Nov 2027 (estimated)
- Study completion
- 19 Nov 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- Ongoing or planned chemotherapy that interferes or is expected to interfere with glycemic control or nutritional intake, particularly in cases of clinically significant gastrointestinal toxicity and/or associated systemic corticosteroid therapy, after consultation with the treating oncologist.
- Enteral or parenteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniMed 780 associated with SimpleraMiniMed 780 associated with Simplera | Device | Sequence 1: MiniMed 780 then usual diabetes treatment, Sequence 2: Usual diabetes treatment then MiniMed 780 |
Primary outcome
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.
4 secondary outcomes
HbA1c
Time frame: At 3 months
Percentage of time below range
Time frame: At 3 months
Glucose coefficient of variation
Time frame: At 3 months
Frequency of acute metabolic events
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Coralie AMADOU, MD principal investigator
Centre Hospitalier Sud Francilien
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiniMed 780 associated with Simplera in people with Pancreatectomy and Total Pancreatectomy, run by Centre Hospitalier Sud Francilien at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Coralie AMADOU, MD (1 61 69 33 87 ext. +33, coralie.amadou@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in range (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.