Using a hybrid closed-loop insulin pump after bariatric surgery in type 1 diabetes patients
Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients with Type 1 Diabetes
This study tests whether using a hybrid closed-loop insulin pump can help people with type 1 diabetes who are obese and have had bariatric surgery manage their blood sugar levels better and avoid low blood sugar.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Sud Francilien Academic / other |
| Locations | 1 site (Corbeil-Essonnes) |
| Trial ID | NCT06294704 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with type 1 diabetes who are obese and have undergone bariatric surgery. It aims to evaluate the long-term efficacy and safety of using a hybrid closed-loop insulin pump in these patients, particularly in relation to managing glucose levels and reducing the risk of hypoglycemia. Continuous glucose monitoring will be utilized to assess the outcomes in this unique patient population. The study seeks to provide insights into the interplay between bariatric surgery and insulin management in type 1 diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with type 1 diabetes for more than one year, who are obese, have undergone bariatric surgery, and are using a hybrid closed-loop insulin pump.
Not a fit: Patients who are not using a hybrid closed-loop insulin pump or those who have not undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve diabetes management and reduce hypoglycemic episodes in patients with type 1 diabetes who have undergone bariatric surgery.
How similar studies have performed: While bariatric surgery has been studied in various contexts, the specific combination of hybrid closed-loop insulin pumps and bariatric surgery in type 1 diabetes patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Corbeil-Essonnes
- Centre Hospitalier Sud Francilien — Corbeil-Essonnes, France (Recruiting)
Study contacts
- Principal investigator: Geoffrey BOULATE, MD — Centre Hospitalier Sud Francilien
- Study coordinator: Geoffrey BOULATE, MD
- Email: geoffrey.boulate@chsf.fr
- Phone: 01.61.69.75.85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.