Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294704
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-02-28
Brief Title:
Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes
Sponsor:
Centre Hospitalier Sud Francilien
Organization:
Centre Hospitalier Sud Francilien
Study Overview
Official Title:
Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PompBariatDT1
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None