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Completed

NCT Number: NCT06294704

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

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.

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Key information

Conditions

Bariatric Surgery Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Other

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

Other names: Hybrid closed-loop insulin pump

Primary outcomes

  1. time spent within glycemic target 70-180 mg/dL

    Time frame: at 3 months

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

Secondary outcomes

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

    Time frame: 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)

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

    Time frame: at 3 months

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

  3. HbA1c

    Time frame: at 3 months

    HbA1c

  4. Coefficient of variation

    Time frame: at 3 months

    Coefficient of variation

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

    Time frame: at 3 months

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

  6. Time spent in level 2 hypoglycemia (< 50 mg/gdl)

    Time frame: at 3 months

    Time spent in level 2 hypoglycemia (< 50 mg/gdl)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: PompBariatDT1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2024
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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