Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295289
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-28
Brief Title:
Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients an Open-label Randomized Controlled Trial
Sponsor:
Huazhong University of Science and Technology
Organization:
Huazhong University of Science and Technology
Study Overview
Official Title:
Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients an Open-label Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Perioperative management of glucose levels remains challenging The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy insulin pump with CGM insulin dose controlled by physicians in controlling glucose levels among patients in the perioperative period
Detailed Description:
Hyperglycemia is particularly frequent in the perioperative period which leads to metabolic and functional disorders aggravates organ damage induces various complications and increases the risk of postoperative infection and even death
However glucose level management among perioperative patients remains challenging because of the frequent blood glucose monitoring requirement and insulin adjustment to accommodate the physiological changes of patients before surgery
In this study we planned to use an open-source hybrid closed-loop insulin delivery system and common insulin pump combined with CGM for short-term intensive insulin therapy in patients with diabetes during the perioperative period To comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop insulin delivery system we planned to compare the blood glucose control and other clinical indicators such as postoperative complications of patients with different intensive insulin therapy regimens If the participant is enrolled before the surgery the following procedure will be followed
Preoperative the participants wear the open-source AP system for treatment
Intraoperative participants should discontinue the insulin pump in advance with the specific timing determined by the endocrinologist The CGM can remain in place as long as it does not interfere with the surgery
Postoperative After the subject returns to the ward the nurse will reinstall the open-source AP system and the treatment will continue for at least 3-4 days
However glucose level management among perioperative patients remains challenging because of the frequent blood glucose monitoring requirement and insulin adjustment to accommodate the physiological changes of patients before surgery
In this study we planned to use an open-source hybrid closed-loop insulin delivery system and common insulin pump combined with CGM for short-term intensive insulin therapy in patients with diabetes during the perioperative period To comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop insulin delivery system we planned to compare the blood glucose control and other clinical indicators such as postoperative complications of patients with different intensive insulin therapy regimens If the participant is enrolled before the surgery the following procedure will be followed
Preoperative the participants wear the open-source AP system for treatment
Intraoperative participants should discontinue the insulin pump in advance with the specific timing determined by the endocrinologist The CGM can remain in place as long as it does not interfere with the surgery
Postoperative After the subject returns to the ward the nurse will reinstall the open-source AP system and the treatment will continue for at least 3-4 days
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