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The Use of Libre to Improve Metabolic Control and Reduce Reliance on Medication

NCT04632849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-10-05

No results posted yet for this study

Summary

GEM (Glycemic Excursion Minimization) is a new lifestyle treatment for type 2 diabetes that aims to lower glucose levels after meals and snacks. This is different from the current lifestyle treatment, which is to lose weight. This study is trying to find out if people who are newly diagnosed with type 2 diabetes can use a continuous glucose monitor together with the GEM lifestyle to improve control of their diabetes. Study participants will follow the GEM lifestyle for 4 months (1 month of treatment and 3 months of maintenance) instead of seeking usual care (medications or weight loss programs) to lower blood glucose.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

GEM + CGM

Participants follow the GEM guidebook for 4 months (1 month of intervention and 3 months of maintenance) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM to provide feedback about activity and blood glucose. The GEM guidebook covers Routine choices, Recovering from blood glucose excursions, Reducing blood glucose excursions, and Maintenance.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • West Virginia University

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Daniel J Cox, PhD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-08-01
Completion
2021-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632849 on ClinicalTrials.gov