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Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes (PompBariatDT1)

C

Centre Hospitalier Sud Francilien

Status

Completed

Conditions

Type 1 Diabetes
Bariatric Surgery

Treatments

Other: bariatric surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06294704
2024/0004

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Major patient
  • With type 1 diabetes for > 1 year
  • Obese (BMI≥30)
  • Having undergone bariatric surgery
  • On a hybrid closed-loop insulin pump
  • Not pregnant
  • No hybrid closed-loop insulin pump discontinuation for more than 45 days after surgery

Exclusion criteria

  • Patient informed and opposed to data use

Trial contacts and locations

3

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Central trial contact

Caroline TOURTE; Geoffrey BOULATE, MD

Data sourced from clinicaltrials.gov

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