Role of CGMS Usage in Predicting Risk for Hypoglycemia



Status:Recruiting
Conditions:Endocrine, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:October 1, 2018
End Date:September 30, 2025

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Development of Novel Predictors of Hypoglycemia for Type 2 Diabetes: Role of CGMS Usage in Predicting Risk for Hypoglycemia

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.


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
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Lisa Chow, MD
Phone: 612-625-8934
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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