Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05392452
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2022-03-25
Brief Title:
Fully Closed-Loop Insulin Delivery in Abdominal Surgery CLAB
Sponsor:
Lia Bally
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Fully Closed-Loop Insulin Delivery in Abdominal Surgery a Randomised Controlled Two-centre Trial CLAB-Study
Status:
COMPLETED
Status Verified Date:
2024-01
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:
CLAB
Brief Summary:
The purpose of the study is to assess the efficacy safety and usability of perioperative fully-automated closed-loop insulin delivery versus standard insulin therapy in patients with diabetes other than type 1 diabetes undergoing elective major abdominal surgery
Detailed Description:
The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated not only with greater complication rates length of stay morbidity and mortality rates but also increased hospital costs and readmission rates Due to the complex interaction of organs involved in glucose homeostasis eg liver pancreas and the frequent need for nutrition support patients undergoing major abdominal surgery are particularly prone to develop dysglycaemia While there are guidelines for perioperative glucose management implementation is challenging and inconsistent Main reasons are lack of resources clinical inertia based on fear of hypoglycaemia and multiple handovers between teams
Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management In previous work the investigators demonstrated that fully closed-loop insulin delivery in adults with type 2 diabetes undergoing various elective surgeries abdominal vascular neurologic orthopaedic thoracic improved glycaemic control by increasing time spent in the glycaemic target range lowering mean sensor glucose and glycaemic variability without increasing the risk of hypoglycaemia
In this follow-up trial the investigators will focus on patients undergoing major elective abdominal surgery to further explore the potential of the fully automated closed-loop approach to accommodate the complex needs of this population Involvement of a second study centre and hospital staff for device management will further allow to assess the usability of the fully closed-loop system for larger multi-centre clinical trials as well as readiness to use the approach in usual clinical care
Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management In previous work the investigators demonstrated that fully closed-loop insulin delivery in adults with type 2 diabetes undergoing various elective surgeries abdominal vascular neurologic orthopaedic thoracic improved glycaemic control by increasing time spent in the glycaemic target range lowering mean sensor glucose and glycaemic variability without increasing the risk of hypoglycaemia
In this follow-up trial the investigators will focus on patients undergoing major elective abdominal surgery to further explore the potential of the fully automated closed-loop approach to accommodate the complex needs of this population Involvement of a second study centre and hospital staff for device management will further allow to assess the usability of the fully closed-loop system for larger multi-centre clinical trials as well as readiness to use the approach in usual clinical care
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