Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607224
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control in Hospitalized Patients with Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control for Insulin Therapy Adjustment and Decision Making in Noncritical Patients with Type 2 Diabetes Hospitalized in Medical and Surgical Wards
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Type 2 diabetes T2D is a common pathology in hospitalized patients and is associated with multiple comorbidities Moreover it is widely known that glycemic excursions increase hospital stay infections morbidity and mortality Likewise asymptomatic hypoglycemia and stress hyperglycemia in hospitalized patients is more frequent due to intercurrent pathology medication alteration of counter-regulatory hormones Therefore the use of continuous glucose monitoring CGM systems would be very useful as it allows early recognition of glycemic excursions and thus improve the management of insulin therapy The primary objective is to demonstrate the increase in time in range TIR with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission The investigators randomized parallel group 2-arm 40 participants 20 in each group patients with diagnosis of T2D prior to admission
Detailed Description:
Over the past few decades advances in diabetes technology have revolutionized patient care and metabolic control The use of CGM has demonstrated substantial benefits on glycemic control in ambulatory patients compared to standard capillary blood glucose CG monitoring However in hospitalized patients limitations on its use persist due to the lack of standardization of the data provided by CGM
The use of CG has been the mainstay for monitoring and adjusting the treatment of hospitalized patients with diabetes In the management for inpatients this test is commonly performed 3 to 4 times a day However this provides significant limitations due to its intermittent nature and the associated time burden for hospital nursing and ancillary staff for its determination
Several studies have demonstrated that CGM detects more hyperglycemia and hypoglycemia in critically ill and non-critically ill patients These studies have provided important information on patterns of glycemic control with emphasis on early detection of glycemic excursions However there is still a need for further research to determine the efficacy of their use in glycemic adjustment reliability in the hospital setting and standardized protocols for their implementation and decision-making
HYPOTHESIS The use of CGM allows an increase in TIR and improves the detection of clinically significant hypoglycemia and hyperglycemia in patients with T2D hospitalized on basal-bolus insulin therapy versus standard CG
The use of CG has been the mainstay for monitoring and adjusting the treatment of hospitalized patients with diabetes In the management for inpatients this test is commonly performed 3 to 4 times a day However this provides significant limitations due to its intermittent nature and the associated time burden for hospital nursing and ancillary staff for its determination
Several studies have demonstrated that CGM detects more hyperglycemia and hypoglycemia in critically ill and non-critically ill patients These studies have provided important information on patterns of glycemic control with emphasis on early detection of glycemic excursions However there is still a need for further research to determine the efficacy of their use in glycemic adjustment reliability in the hospital setting and standardized protocols for their implementation and decision-making
HYPOTHESIS The use of CGM allows an increase in TIR and improves the detection of clinically significant hypoglycemia and hyperglycemia in patients with T2D hospitalized on basal-bolus insulin therapy versus standard CG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None