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

NCT06294704 | Completed

• 1 other identifier: 2024/0004
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Bariatric Surgery; Type 1 Diabetes

Keywords

Bariatric surgery; type 1 diabetes; hybrid closed-loop insulin pump

Outcome Measures

Primary Outcomes (1)

• time spent within glycemic target 70-180 mg/dL

  time spent within glycemic target 70-180 mg/dL in type 1 diabetes patients who underwent bariatric surgery,

  at 3 months

Secondary Outcomes (6)

• Time spent in level 1 hyperglycemia (181-250 mg/dL)

  at 3 months

• Time spent in level 2 hyperglycemia (>250 mg/dL)

  at 3 months

• HbA1c

  at 3 months

• Coefficient of variation

  at 3 months

• Time spent in level 1 hypoglycemia (51-70 mg/dl)

  at 3 months

Interventions

bariatric surgery OTHER

Having undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery

Also known as: Hybrid closed-loop insulin pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with type 1 diabetes who underwent bariatric surgery and treated by hybrid closed-loop insulin pump.

You may qualify if:

• 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

You may not qualify if:

• \- Patient informed and opposed to data use

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (3)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

Location

CHU de Nantes

Nantes, France, 44000, France

Location

APHP Hôpital de la Pitié Salpètrière

Paris, France, 75013, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Geoffrey BOULATE, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: April 23, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)