Role of CGMS Usage in Predicting Risk for Hypoglycemia

April 23, 2024 updated by: University of Minnesota

Development of Novel Predictors of Hypoglycemia for Type 2 Diabetes: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with type 2 diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blinded
Continuing Glucose Monitoring System will be blinded
Device: Continuing Glucose Monitor System
glucose monitoring
Unblinded
Continuing Glucose Monitoring System will be open. Participant can review results if they choose.
Device: Continuing Glucose Monitor System
glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia rate
Time Frame: Week 16
Overall rate
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison hypoglycemia rate
Time Frame: Week 16
Comparison between blinded and unblinded arms
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2017-26285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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