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

Recruiting

• Conditions: Type 1 Diabetes; Bariatric Surgery

• Registration Number: NCT06294704
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-05
• Study Start: 2024-04-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• Patient informed and opposed to data use

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time spent within glycemic target 70-180 mg/dL	at 3 months	time spent within glycemic target 70-180 mg/dL in type 1 diabetes patients who underwent bariatric surgery,

Secondary Outcome Measures

Name	Time	Method
HbA1c	at 3 months	HbA1c
Time spent in level 2 hyperglycemia (>250 mg/dL)	at 3 months	Time spent in level 2 hyperglycemia (\>250 mg/dL)
Coefficient of variation	at 3 months	Coefficient of variation
Time spent in level 1 hyperglycemia (181-250 mg/dL)	at 3 months	Time spent in level 1 hyperglycemia (181-250 mg/dL); Time spent in level 1 hyperglycemia (181-250 mg/dL); Time spent in level 1 hyperglycemia (181-250 mg/dL)
Time spent in level 1 hypoglycemia (51-70 mg/dl)	at 3 months	Time spent in level 1 hypoglycemia (51-70 mg/dl)
Time spent in level 2 hypoglycemia (< 50 mg/gdl)	at 3 months	Time spent in level 2 hypoglycemia (\< 50 mg/gdl)

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France