Status:
WITHDRAWN
CGM/Clarity Use, Glycemic Control and Clinical Outcomes
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Baltimore VA Medical Center
Conditions:
Diabetes Mellitus
Hyperglycemia
Eligibility:
All Genders
21+ years
Phase:
NA
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 gl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03827434
Start Date
November 22 2024
End Date
November 22 2024
Last Update
November 26 2024
Active Locations (1)
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1
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201