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

April 5, 2024 updated by: Centre Hospitalier Sud Francilien
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 3 months
Time spent in level 2 hyperglycemia (>250 mg/dL)
Time Frame: at 3 months
Time spent in level 2 hyperglycemia (>250 mg/dL)
at 3 months
HbA1c
Time Frame: at 3 months
HbA1c
at 3 months
Coefficient of variation
Time Frame: at 3 months
Coefficient of variation
at 3 months
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)
at 3 months
Time spent in level 2 hypoglycemia (< 50 mg/gdl)
Time Frame: at 3 months
Time spent in level 2 hypoglycemia (< 50 mg/gdl)
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Geoffrey BOULATE, MD, Centre Hospitalier Sud Francilien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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