CGM/Clarity Use, Glycemic Control and Clinical Outcomes

NCT03827434 | Withdrawn DMC FDA Device

• 1 other identifier: HP-00084458
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change in Hemoglobin A1c (HbA1c) among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)

  Through study completion, 6 months after randomization

• Change in the number of hypoglycemic episodes among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)

  Through study completion, 6 months after randomization

• Change in the number of hospitalizations among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)

  Through study completion, 6 months after randomization

• Change in the number of ED visits among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)

  Through study completion, 6 months after randomization

• Change in mortality among participants who are managed with Continuous Glucose Monitoring Devices and Clarity versus participants who are managed with Point of Care glucose testing (standard of care)

  Through study completion, 6 months after randomization

Study Arms (2)

Continuous glucose Monitoring and Clarity

ACTIVE COMPARATOR

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

Device: Continuous glucose Monitoring Devices and Clarity Software

Point of Care Fingerstick Glucose values

PLACEBO COMPARATOR

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

Other: Point of Care (POC) blood glucose

Interventions

Continuous glucose Monitoring Devices and Clarity Software DEVICE

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

Continuous glucose Monitoring and Clarity

Point of Care (POC) blood glucose OTHER

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

Point of Care Fingerstick Glucose values

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Baltimore VA Medical Center: collaborator

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Interventions

Point-of-Care Systems; Blood Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hospital Information Systems; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration; Management Information Systems; Patient Care Management; Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, VA Staff Physician

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 1, 2019
• Study Start: November 22, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)