Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-27 @ 9:34 AM
Study NCT ID:
NCT06227650
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed-loop Insulin Delivery Systems in Pancreatic Diabetes
Sponsor:
Centre Hospitalier Sud Francilien
Organization:
Study Overview
Official Title:
Closed-loop Insulin Delivery Systems ("Artificial Pancreas") in Patients With Pancreatitis or Pancreatectomy-induced Diabetes: an Observational Case Series
Status:
COMPLETED
Status Verified Date:
2024-04
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:
IADIASP
Brief Summary:
The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas").
Detailed Description:
Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.
A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.
A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.
Study Oversight
Has Oversight DMC:
False
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?: