NCT05580978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

October 6, 2022

Last Update Submit

January 31, 2025

Conditions

PreDiabetes

Keywords

prediabeteslifestyle guidecontinuous glucose monitorprevention

Outcome Measures

Primary Outcomes (1)

  • Change in percentage of CGM glucose readings > 120 mg/dL

    Change in percentage of CGM glucose readings \> 120 mg/dL from pre-intervention blinded CGM to post-intervention blinded CGM.

    4.5 months

Secondary Outcomes (9)

  • Change in HbA1c

    4.5 months

  • Change in Glucose Variability

    4.5 months

  • Change in Body Mass Index

    4.5 months

  • Change in Cardiovascular Risk

    4.5 months

  • Change in Empowerment

    4.5 months

  • +4 more secondary outcomes

Study Arms (2)

GEM + CGM + Activity Monitor

EXPERIMENTAL

GEM plus CGM and Activity Monitor (FitBit)

Behavioral: GEM

Routine Care

ACTIVE COMPARATOR

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

Other: Routine Care

Interventions

GEMBEHAVIORAL

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.

GEM + CGM + Activity Monitor
Routine CareOTHER

Participant's current prediabetes treatment.

Routine Care

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tamara Oser, MD

    Associate Professor, Dept. Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 14, 2022

Study Start

November 1, 2022

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)