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Clinical Trials/NCT03481530
NCT03481530
Completed
Not Applicable

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

University of Minnesota1 site in 1 country41 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
University of Minnesota
Enrollment
41
Locations
1
Primary Endpoint
Hypoglycemia rate
Status
Completed
Last Updated
6 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
September 30, 2025
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hypoglycemia rate

Time Frame: Week 16

Overall rate

Secondary Outcomes

  • Comparison hypoglycemia rate(Week 16)

Study Sites (1)

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