Pancreatectomy, Partial Pancreatectomy, Total Pancreatectomy
Conditions
Keywords
diabetes, pancreatectomy, hybrid cloosed-loop, automatised insulin delivery
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.
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.
Interventions
DEVICEMiniMed 780 associated with Simplera
MiniMed 780 associated with Simplera
Sponsors
Centre Hospitalier Sud Francilien
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in range | 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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. |
| Percentage of time below range | 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. |
| Glucose coefficient of variation | 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. |
| Frequency of acute metabolic events | 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. |
Countries
France
Contacts
CONTACTCoralie AMADOU, MD
CONTACTCaroline TOURTE
PRINCIPAL_INVESTIGATORCoralie AMADOU, MD
Centre Hospitalier Sud Francilien
Outcome results
None listed