Role of CGMS Usage in Predicting Risk for Hypoglycemia

Active, not recruiting

• Conditions: Hypoglycemia; Type 2 Diabetes Mellitus
• Interventions: Device: Continuing Glucose Monitor System

• Registration Number: NCT03481530
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Study Start: 2018-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Type 2 Diabetes
• 18 years or older

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unblinded	Continuing Glucose Monitor System	Continuing Glucose Monitoring System will be open. Participant can review results if they choose.
Blinded	Continuing Glucose Monitor System	Continuing Glucose Monitoring System will be blinded

Primary Outcome Measures

Name	Time	Method
Hypoglycemia rate	Week 16	Overall rate

Secondary Outcome Measures

Name	Time	Method
Comparison hypoglycemia rate	Week 16	Comparison between blinded and unblinded arms

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States