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NCT03481530 Clinical Trial

Role of CGMS Usage in Predicting Risk for Hypoglycemia

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03481530
Other study ID # MED-2017-26285
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date September 30, 2025

Study information
Verified date April 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 41
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuing Glucose Monitor System
glucose monitoring

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypoglycemia rate Overall rate Week 16
Secondary Comparison hypoglycemia rate Comparison between blinded and unblinded arms Week 16
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