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Completed

NCT Number: NCT05580978

CGM Plus GEM in Prediabetes

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GEM

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

Other

Participant's current prediabetes treatment.

Primary outcomes

  1. Change in Percentage of CGM Glucose Readings > 120 mg/dL

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in percentage of CGM glucose readings > 120 mg/dL from pre-intervention (baseline) blinded CGM to post-intervention (4.5 months) blinded CGM.

Secondary outcomes

  1. Change in HbA1c

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in HbA1c from pre-intervention (baseline) to post-intervention (4.5 months).

  2. Change in Glucose Variability

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in glucose variability (GV%) as measured by CGM, from pre-intervention (baseline) to post-intervention (4.5 months).

    Glucose variability was measured by CGM metrics coefficient of variation (%CV) and Standard Deviation (SD).

  3. Change in Body Mass Index

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in Body Mass Index (BMI) from pre-intervention (baseline) to post-intervention (4.5 months).

  4. Change in Cardiovascular Risk

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in cardiovascular risk as calculated by a validated risk calculator from pre-intervention (baseline) to post-intervention (4.5 months).

    The ASCVD Risk Estimator Plus was used to calculate cardiovascular risk. It provides a percentage score that estimates 10-year risk of having a heart attack or stroke. Low risk <5%, Borderline (5%-7.4%) Intermediate (7.5%-19.9%) High (> 20%).

  5. Change in Empowerment

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in empowerment as measured by modified Diabetes Empowerment Scale-Short Form, from pre-intervention (baseline) to post-intervention (4.5 months).

    The Diabetes Empowerment Scale-Short Form measures the psychosocial self-efficacy of people with diabetes. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point. All items are summed, "Low" = 8-20, "Moderate" = 21-30, "High" = 31-40. Possible scores on the scale ranges from 8-40.

  6. Change in Depressive Symptoms

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in depression score as measured by PHQ-8 at pre-intervention (baseline) and post-intervention (4.5 months).

    The Patient Health Questionnaire-8 is a self-report screening tool for depression. Each item scores 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 24, with higher scores indicating greater depression severity.

  7. Change in Diabetes Knowledge

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in diabetes knowledge as measured by a modified Diabetes Knowledge Scale from pre-intervention (baseline) to post-intervention (4.5 months).

    The Diabetes Knowledge Scale is a valid measure containing 30 questions for assessing diabetes knowledge. The items are scored as correct or incorrect, and the correct items were summed to obtain a total score. Scores range from 0 to 30, with higher scores indicating greater knowledge.

  8. Dietary Habits

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in dietary habits as measured by Carbohydrate Routine Consumption Scale (CRC) from pre-intervention (baseline) to post-intervention (4.5 months).

    The CRC measures carb intake, focusing on how much and what kind (high vs. low glycemic impact), rather than daily total grams. Scoring involves evaluating foods on a 4 or 5-point scale based on nutrients like fiber, free sugars, sodium, and potassium, guiding better choices by highlighting healthier options within carb categories, with higher scores indicating better quality. The CRC score is the sum of the number of servings of 16 different high-carb food classes eaten (e.g., dried fruits) in an average week. There are no subscales. Scale minimum is 0 (zero consumption of high-carb food foods). There is no scale maximum (people may eat as many servings of high glycemic load foods as they like). The CRC is not a comprehensive nutritional analysis. https://diabetesjournals.org/diabetes/article/68/Supplement_1/806-P/58163

  9. Motivation and Attitudes Toward Changing Health

    Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)

    Change in Motivation and Attitudes Toward Changing Health (MATCH) score from pre-intervention (baseline) to post-intervention (4.5 months).

    The Motivation and Attitudes Toward Changing Health (MATCH) is a 9-item scale that provides a profile of factors influencing motivation. Patients rate their agreement on a 5-point scale (1=Strongly Disagree, 5=Strongly Agree). An average of all items or subscales provides an overall score/motivational profile. Higher Scores (closer to 5) indicate stronger motivation, ability, and belief in the value of change, while lower Scores (closer to 1) suggest potential barriers, such as ambivalence, perceived lack of control, or feeling changes aren't impactful.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Abbott Diabetes Care
  • University of Virginia

Registry information

Official study title

Libre 2 CGM Plus Glycemic Excursion mIniMization (GEM) in the Treatment of PrEDiabEtes

Acronym: IMPEDE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2022
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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