Clinical Trials Directory

Trials / Completed

CompletedNCT06294704

Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes

Status
Completed
Phase
Study type
Observational
Enrollment
17 (actual)
Sponsor
Centre Hospitalier Sud Francilien · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.

Detailed description

Patients with type 1 diabetes and obesity are at risk of "double diabetes". Bariatric surgery may be indicated for these patients, to combat insulin resistance. Nevertheless, post-operative patients are at risk of hypoglycemia. At the same time, patients with type 1 diabetes can benefit from a hybrid closed loop insulin pump to improve diabetes control and reduce the occurrence of hypoglycemia. In type 1 diabetic patients who have undergone bariatric surgery and are treated with a hybrid closed loop insulin pump, continuous glucose measurement can be studied. In the medium and long term, the efficacy and safety of this system in this context will be described.

Conditions

Interventions

TypeNameDescription
OTHERbariatric surgeryHaving undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery

Timeline

Start date
2024-04-23
Primary completion
2025-06-30
Completion
2025-06-30
First posted
2024-03-05
Last updated
2025-08-17

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06294704. Inclusion in this directory is not an endorsement.