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

Type 1 Diabetes Clinical Trial

— PompBariatDT1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06294704
• Other study ID #: 2024/0004
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Sud Francilien
• Contact: Geoffrey BOULATE, MD
• Phone: 01.61.69.75.85
• Email: geoffrey.boulate[@]chsf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	at 3 months
Secondary	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)	at 3 months
Secondary	Time spent in level 2 hyperglycemia (>250 mg/dL)	Time spent in level 2 hyperglycemia (>250 mg/dL)	at 3 months
Secondary	HbA1c	HbA1c	at 3 months
Secondary	Coefficient of variation	Coefficient of variation	at 3 months
Secondary	Time spent in level 1 hypoglycemia (51-70 mg/dl)	Time spent in level 1 hypoglycemia (51-70 mg/dl)	at 3 months
Secondary	Time spent in level 2 hypoglycemia (< 50 mg/gdl)	Time spent in level 2 hypoglycemia (< 50 mg/gdl)	at 3 months