Other Clinical Trial - CGM/Clarity Use, Glycemic Control & Clinical

Status Withdrawn

Clinical Trial Summary

The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or 9.4% 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 visits,which 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 times/day. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03827434
Study type	Interventional
Source	University of Maryland, Baltimore
Contact
Status	Withdrawn
Phase	N/A
Start date	December 1, 2018
Completion date	October 31, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

CGM/Clarity Use, Glycemic Control and Clinical Outcomes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms