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OpenTrials
Completed

NCT Number: NCT03481530

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuing Glucose Monitor System

Device

glucose monitoring

Primary outcomes

  1. Hypoglycemia rate

    Time frame: Week 16

    Overall rate

Secondary outcomes

  1. Comparison hypoglycemia rate

    Time frame: Week 16

    Comparison between blinded and unblinded arms

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Mar 29, 2018
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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