Role of CGMS Usage in Predicting Risk for Hypoglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2025-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blinded

Continuing Glucose Monitoring System will be blinded

Continuing Glucose Monitor System

Intervention Type DEVICE

glucose monitoring

Unblinded

Continuing Glucose Monitoring System will be open. Participant can review results if they choose.

Continuing Glucose Monitor System

Intervention Type DEVICE

glucose monitoring

Interventions

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Continuing Glucose Monitor System

glucose monitoring

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No