CGM Plus GEM in Prediabetes

NCT ID: NCT05580978

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-01-15

Brief Summary

This study is designed to look into the effect of a lifestyle management guide called GEM (Glycemic Excursion Minimization) alongside continuous glucose monitoring (CGM) and an activity monitor (FitBit) and the effect this can have on persons with prediabetes.

Detailed Description

For people with prediabetes, it may be possible to delay or prevent the progression to diabetes by reducing postprandial glucose (PPG). The Glycemic Excursion Minimization (GEM) lifestyle intervention guide can reduce PPG in people with type 2 diabetes and has been studied in this population with continuous glucose monitor (CGM) feedback to help the user learn what elevates and lowers their PPG. This study examines if the GEM lifestyle intervention guide plus continuous feedback from the FreeStyle Libre 2 CGM and FitBit will allow participants with prediabetes with HbA1c 6.0-6.4% to (1) improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their glucose levels and variability, more than Routine Care (RC), and (2) to enhance these investigations by adding comprehensive plasma proteomics to the analyses. The investigators will recruit up to 36 adult participants with prediabetes through the University of Colorado, with the goal of having at least 30 participants complete the study. Participants will be randomized to the intervention or RC. Those randomized to the intervention will be given a GEM treatment manual, Libre2 CGM, and an activity monitor and will follow the GEM lifestyle intervention guide for 4 months. Those participants randomized to RC will follow recommendations from their primary care provider. RC participants will have the opportunity to receive GEM four months after consenting and completing the RC pre-post assessments if they meet eligibility criteria. It is anticipated that 50% of the RC participants will want/be able to cross over to GEM upon completion of RC. Pre-post blinded CGM data and activity data, clinical, and psychosocial outcomes will be collected and analyzed. It is anticipated that this pilot project will demonstrate the benefits of using GEM plus FreeStyle Libre 2 and FitBit to reduce percentage of CGM readings >120 mg/dL, from blinded pre-post FreeStyle Libre Pro, as well as reduce BMI and depressive symptoms and increase modified diabetes empowerment. Comprehensive proteomics will be measured on small samples of EDTA treated venous blood. Individual proteins and protein pathways will be measured for each of the participants.

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GEM + CGM + Activity Monitor

GEM plus CGM and Activity Monitor (FitBit)

Group Type: EXPERIMENTAL

GEM

Intervention Type: BEHAVIORAL

The intervention group will be given Libre 2 supplies for 4 months, an activity monitor, and the 4-chapter GEM paper guide. The intervention group will complete a virtual or inperson study visit where they will receive instructions on how to apply their unblinded Freestyle Libre and connect it to the study account, as well as how to register their Fitbit to the study account. Participants will receive one telephone call to review use of the GEM Guide and call at two weeks and six weeks later when the probability of dropouts from lifestyle intervention peaks. Participants will follow the self-directed GEM guide for 4 months (a 1-month treatment period followed by a 3-month maintenance period) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM.

Routine Care

Usual care already being received for prediabetes as treated by their care team.

Group Type: ACTIVE_COMPARATOR

Routine Care

Intervention Type: OTHER

Participant's current prediabetes treatment.

Interventions

GEM

The intervention group will be given Libre 2 supplies for 4 months, an activity monitor, and the 4-chapter GEM paper guide. The intervention group will complete a virtual or inperson study visit where they will receive instructions on how to apply their unblinded Freestyle Libre and connect it to the study account, as well as how to register their Fitbit to the study account. Participants will receive one telephone call to review use of the GEM Guide and call at two weeks and six weeks later when the probability of dropouts from lifestyle intervention peaks. Participants will follow the self-directed GEM guide for 4 months (a 1-month treatment period followed by a 3-month maintenance period) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM.

Intervention Type: BEHAVIORAL

Routine Care

Participant's current prediabetes treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 25-70 years
• A1C 6.0-6.4
• Documented diagnosis of prediabetes
• Have a smart phone
• Able to read English, as the GEM guide is currently only available in English
• Willing and able to follow the study procedures as instructed

Exclusion Criteria

• Diagnosis of diabetes mellitus
• Currently taking any diabetes medication
• Currently taking medication that promotes insulin resistance or otherwise interferes with metabolic control (e.g., prednisone)
• Has a condition that precludes a low carbohydrate diet, such as gastroparesis
• Has a physical or medical condition that precludes walking 120 steps per minute for 10 minutes or longer
• Has documented kidney disease that would preclude participation in study per PI discretion
• Active or planned cancer treatment
• Extreme visual or hearing impairment that would impair ability to use real-time CGM
• Pregnant or anticipates becoming pregnant in the next 4 months
• Anticipates moving within the next 4 months
• Treating physician, for any reason, considers their patient inappropriate for the study (e.g., uncontrolled bipolar disease)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Diabetes Care

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara Oser, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Dept. Family Medicine

Locations

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

21-4931

Identifier Type: -

Identifier Source: org_study_id