Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03827434
Status:
WITHDRAWN
Last Update Posted:
2023-09-22
First Post:
2019-01-28
Brief Title:
CGMClarity Use Glycemic Control and Clinical Outcomes
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Improving Glycemic Control and Clinical Outcomes in Insulin Treated DM2 Patients Managed With CGM Devices and Clarity a Randomized Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We did not receive funding to conduct the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of Diabetes Mellitus DM is rising and more than 30 million of Americans or 94 of the US population has DM Several large scale randomized clinical trials have found that improved glycemic control reduces the development of complications in patients with DM However intensive glucose management carries an increased risk of hypoglycemia a condition that may lead to neurological damage and is associated with increased incidence of cardiovascular events and mortality
Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important objective as may decrease the direct and indirect impact that diabetes has in our health care system Achieving optimal glycemic control requires frequent blood glucose monitoring by the patients and recurrent clinic visitswhich is often difficult to achieve as access to typical DM clinic is at least sub optimal
m-Health and telemedicine health solutions represent alternative ways to manage patients in the outpatient setting and have been applied in different medical areas among them in diabetes However almost all the telemedicine studies that have been previously performed and recruited DM patients used telemedicine solutions which were based on point of care POC finger-stick glucose testing which are checked infrequently usually 4-6 timesday
Continuous glucose monitoring CGM devices offer additional ways to monitor blood glucose values and can provide numerous glucose measurements as frequent as every 5 min By using software applications such as the Clarity Dexcom which highlights glucose patterns trends and statistics in standardized reports providers can make safe recommendations of adjusting DM medications especially insulin titration In this randomized clinical trial investigators propose to use CGM devices and Clarity software as a telemedicine platform in order to improve glycemic control and improve health outcomes
Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important objective as may decrease the direct and indirect impact that diabetes has in our health care system Achieving optimal glycemic control requires frequent blood glucose monitoring by the patients and recurrent clinic visitswhich is often difficult to achieve as access to typical DM clinic is at least sub optimal
m-Health and telemedicine health solutions represent alternative ways to manage patients in the outpatient setting and have been applied in different medical areas among them in diabetes However almost all the telemedicine studies that have been previously performed and recruited DM patients used telemedicine solutions which were based on point of care POC finger-stick glucose testing which are checked infrequently usually 4-6 timesday
Continuous glucose monitoring CGM devices offer additional ways to monitor blood glucose values and can provide numerous glucose measurements as frequent as every 5 min By using software applications such as the Clarity Dexcom which highlights glucose patterns trends and statistics in standardized reports providers can make safe recommendations of adjusting DM medications especially insulin titration In this randomized clinical trial investigators propose to use CGM devices and Clarity software as a telemedicine platform in order to improve glycemic control and improve health outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None