CGM/Clarity Use, Glycemic Control and Clinical Outcomes

NCT ID: NCT03827434

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2024-11-22

Brief 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.

Conditions

Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous glucose Monitoring and Clarity

Patients with DM2 and abnormal glycemic control followed by Continuous glucose Monitoring, using Clarity software

Group Type: ACTIVE_COMPARATOR

Continuous glucose Monitoring Devices and Clarity Software

Intervention Type: DEVICE

Patients with DM2 at the intervention group will be managed by Continuous glucose Monitoring and Clarity software

Point of Care Fingerstick Glucose values

Patients with DM2 and abnormal glycemic control followed by Point of Care Fingerstick Glucose values

Group Type: PLACEBO_COMPARATOR

Point of Care (POC) blood glucose

Intervention Type: OTHER

Testing Blood Glucose levels with Point of Care (POC) blood glucose

Interventions

Continuous glucose Monitoring Devices and Clarity Software

Patients with DM2 at the intervention group will be managed by Continuous glucose Monitoring and Clarity software

Intervention Type: DEVICE

Point of Care (POC) blood glucose

Testing Blood Glucose levels with Point of Care (POC) blood glucose

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• History of Diabetes Mellitus type 2 (DM2) on insulin
• Uncontrolled glycemic control [hyperglycemia defined as Hba1c≥9% in the last 3 months or clinically important hypoglycemia (any reported glucose values less than 54 mg/dl) or severe hypoglycemia (low glucose value that led to a severe event characterized by altered mental status and or physical status requiring assistance)]

Exclusion Criteria

• Subjects that have a history of type 1 DM
• History of type 2 DM, not treated or required to be treated with basal/bolus insulin (i.e diet only, any combination of non insulin antidiabetic drugs only, basal only insulin or bolus/short acting only insulin, or pre-mixed insulins) as these patients are less likely to benefit from CGM use.
• Pregnant patients
• Use of Clarity/ Share or follow applications as telehealth/telemedicine to improve DM management during the last 3 months prior to study entry.
• Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
• Significant psychiatric illness or any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study.
• Subjects without personal computer and internet network access.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baltimore VA Medical Center

FED

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Ilias Spanakis

Assistant Professor of Medicine, VA Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baltimore VA Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00084458

Identifier Type: -

Identifier Source: org_study_id