---
title: Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes
nct_id: NCT06294704
overall_status: COMPLETED
sponsor: Centre Hospitalier Sud Francilien
study_type: OBSERVATIONAL
primary_condition: Bariatric Surgery
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06294704.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06294704"
ct_last_update_post_date: 2025-08-17
last_seen_at: "2026-05-12T07:28:34.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes

**NCT ID:** [NCT06294704](https://clinicaltrials.gov/study/NCT06294704)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 17
- **Lead Sponsor:** Centre Hospitalier Sud Francilien
- **Conditions:** Bariatric Surgery, Type 1 Diabetes
- **Start Date:** 2024-04-23
- **Completion Date:** 2025-06-30
- **CT.gov Last Update:** 2025-08-17

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **bariatric surgery** (OTHER) — Having undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery

## Primary Outcomes

- **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

- **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)_

## Locations (3)

- Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France, France
- CHU de Nantes, Nantes, France, France
- APHP Hôpital de la Pitié Salpètrière, Paris, France, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre hospitalier sud francilien|corbeil-essonnes|france|france` — added _(2026-05-12)_
- `locations.chu de nantes|nantes|france|france` — added _(2026-05-12)_
- `locations.aphp hôpital de la pitié salpètrière|paris|france|france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06294704.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06294704*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*