Bariatric SurgeryPompBariatDT1NCT06294704
Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes
An observational study of Bariatric Surgery and Type 1 Diabetes, run by Centre Hospitalier Sud Francilien at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Type 1 Diabetes
- What is being tested?
- bariatric surgery
- How many people
- 17 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Apr 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with type 1 diabetes who underwent bariatric surgery and treated by hybrid closed-loop insulin pump.
Who may be able to join
- 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
Who cannot join
- Patient informed and opposed to data use
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
CHU de Nantes
Nantes, France, 44000
APHP Hôpital de la Pitié Salpètrière
Paris, France, 75013
About this study
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.
- Conditions
- Bariatric Surgery, Type 1 Diabetes
- Being tested
- bariatric surgery
- Keywords
- Bariatric surgery, type 1 diabetes, hybrid closed-loop insulin pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryOther
Also called Hybrid closed-loop insulin pump
Having undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: at 3 months
Secondary outcomes (6)
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)
Measured: at 3 months
Time spent in level 2 hyperglycemia (>250 mg/dL)
Time spent in level 2 hyperglycemia (>250 mg/dL)
Measured: at 3 months
HbA1c
HbA1c
Measured: at 3 months
Coefficient of variation
Coefficient of variation
Measured: at 3 months
Time spent in level 1 hypoglycemia (51-70 mg/dl)
Time spent in level 1 hypoglycemia (51-70 mg/dl)
Measured: at 3 months
Time spent in level 2 hypoglycemia (< 50 mg/gdl)
Time spent in level 2 hypoglycemia (< 50 mg/gdl)
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start23 Apr 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey BOULATE, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294704
- Sponsor's protocol ID
- 2024/0004
- Acronym
- PompBariatDT1
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06294704
- Acronym / sponsor ID
- PompBariatDT1 / 2024/0004
- Conditions
- Bariatric Surgery, Type 1 Diabetes
- Keywords
- Bariatric surgery, type 1 diabetes, hybrid closed-loop insulin pump
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with type 1 diabetes who underwent bariatric surgery and treated by hybrid closed-loop insulin pump.
Key inclusion criteria (7 listed)
- Major patient
- With type 1 diabetes for > 1 year
- Obese (BMI≥30)
- Having undergone bariatric surgery
- On a hybrid closed-loop insulin pump
Key exclusion criteria (1 listed)
- Patient informed and opposed to data use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgeryAlso: Hybrid closed-loop insulin pumpHaving undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery | Other | – |
Primary outcome
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,
6 secondary outcomes
Time spent in level 1 hyperglycemia (181-250 mg/dL)
Time frame: at 3 months
Time spent in level 2 hyperglycemia (>250 mg/dL)
Time frame: at 3 months
HbA1c
Time frame: at 3 months
Coefficient of variation
Time frame: at 3 months
Time spent in level 1 hypoglycemia (51-70 mg/dl)
Time frame: at 3 months
Time spent in level 2 hypoglycemia (< 50 mg/gdl)
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey BOULATE, MD principal investigator
Centre Hospitalier Sud Francilien
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Type 1 Diabetes, run by Centre Hospitalier Sud Francilien at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time spent within glycemic target 70-180 mg/dL (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.