Role of CGMS Usage in Predicting Risk for Hypoglycemia
Development of Novel Predictors of Hypoglycemia for Type 2 Diabetes: Role of CGMS Usage in Predicting Risk for Hypoglycemia
1 other identifier
observational
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedOctober 15, 2025
October 1, 2025
1.3 years
March 21, 2018
October 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Hypoglycemia rate
Overall rate
Week 16
Secondary Outcomes (1)
Comparison hypoglycemia rate
Week 16
Study Arms (2)
Blinded
Continuing Glucose Monitoring System will be blinded
Unblinded
Continuing Glucose Monitoring System will be open. Participant can review results if they choose.
Interventions
Eligibility Criteria
Adults with type 2 diabetes
You may qualify if:
- Type 2 Diabetes
- years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Olawsky E, Zhang Y, Eberly LE, Helgeson ES, Chow LS. A New Analysis Tool for Continuous Glucose Monitor Data. J Diabetes Sci Technol. 2022 Nov;16(6):1496-1504. doi: 10.1177/19322968211028909. Epub 2021 Jul 20.
PMID: 34282646DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2018
First Posted
March 29, 2018
Study Start
October 1, 2018
Primary Completion
January 13, 2020
Study Completion
September 30, 2025
Last Updated
October 15, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share