Role of CGMS Usage in Predicting Risk for Hypoglycemia
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About
This is a clinical study to examine rates hypoglycemia (self-report, EHR review, and review of values from a FDA approved continuous glucose monitoring system (CGMS)). Subjects will wear either blinded or unblinded CGMS. This is a 1:1 assignment with one group (50%) wearing 1 unblinded/1 blinded CGMS and the other group 50% wearing 2 blinded CGMS. The assignment will be computer based in a random fashion. Participants will continue with their usual diabetes management and glycemic monitoring profile as per usual. Those assigned to an unblinded CGMS can use the CGMS to manage their glucose levels at their own discretion. Individuals recruited will be those Type 2 diabetes who are deemed to be at high risk for hypoglycemia or low risk for hypoglycemia from a point score system established in an affiliated study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Type 2 Diabetes
- 18 years or older
Exclusion criteria
- Type 1 diabetes
- Current pregnancy or anticipation of pregnancy during study period
- At screening visit, HR> 130 or SBP>160 or DBP>100 which remains present on recheck
Trial design
41 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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