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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Hospitalier Sud Francilien
RECRUITING
Corbeil-essonnes
Hôpital Bichat (APHP)
NOT_YET_RECRUITING
Paris
Contact Information
Primary
Coralie AMADOU, MD
coralie.amadou@chsf.fr
1 61 69 33 87
Backup
Caroline TOURTE
caroline.tourte@chsf.fr
1 61 69 31 50
Time Frame
Start Date: 2026-05-19
Estimated Completion Date: 2027-11-19
Participants
Target number of participants: 24
Treatments
Experimental: Sequence 1: MiniMed 780 then usual diabetes treatment
Experimental: Sequence 2: Usual diabetes treatment then MiniMed 780
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Sud Francilien

This content was sourced from clinicaltrials.gov