CClinicalTrials.gg
CompletedNCT06294704PompBariatDT1Updated Aug 17, 2025

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

An observational study in Bariatric Surgery and Type 1 Diabetes, sponsored by Centre Hospitalier Sud Francilien. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Centre Hospitalier Sud Francilien · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bariatric Surgery
  • Type 1 Diabetes

Keywords

  • Bariatric surgery
  • type 1 diabetes
  • hybrid closed-loop insulin pump
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 17 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Centre Hospitalier Sud Francilien is the lead sponsor of 57 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

- Patient informed and opposed to data use

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
17 participants (actual)
Patient registry
No

Interventions

  • Otherbariatric surgery

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

    Also known as: Hybrid closed-loop insulin pump

06

What researchers measure

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,

    Time frame: at 3 months

Secondary outcomes

  1. 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 hyperglycemia (181-250 mg/dL)

    Time frame: at 3 months

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

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

    Time frame: at 3 months

  3. HbA1c

    HbA1c

    Time frame: at 3 months

  4. Coefficient of variation

    Coefficient of variation

    Time frame: at 3 months

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

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

    Time frame: at 3 months

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

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

    Time frame: at 3 months

07

Study locations

3 sites
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, France 91106, France
  • CHU de Nantes
    Nantes, France 44000, France
  • APHP Hôpital de la Pitié Salpètrière
    Paris, France 75013, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06294704
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
Mar 5, 2024
Start date
Apr 23, 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Aug 17, 2025

Study contacts

Geoffrey BOULATE, MD
principal investigator · Centre Hospitalier Sud Francilien

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion