PreDiabetesIMPEDENCT05580978
CGM Plus GEM in Prediabetes
A study testing GEM and Routine Care in people with PreDiabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- GEM and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Libre 2 CGM Plus Glycemic Excursion mIniMization (GEM) in the Treatment of 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.
Read the 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
- Being tested
- GEM, Routine Care
- Keywords
- prediabetes, lifestyle guide, continuous glucose monitor, prevention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEMBehavioural
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 CareOther
Participant's current prediabetes treatment.
| Study group | Role | What they receive |
|---|---|---|
| GEM + CGM + Activity Monitor | Experimental | GEM plus CGM and Activity Monitor (FitBit) Receives: Behavioral: GEM |
| Routine Care | Active comparator | Usual care already being received for prediabetes as treated by their care team. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of CGM Glucose Readings > 120 mg/dL
Change in percentage of CGM glucose readings > 120 mg/dL from pre-intervention (baseline) blinded CGM to post-intervention (4.5 months) blinded CGM.
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Secondary outcomes (9)
Change in HbA1c
Change in HbA1c from pre-intervention (baseline) to post-intervention (4.5 months).
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Glucose Variability
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).
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Body Mass Index
Change in Body Mass Index (BMI) from pre-intervention (baseline) to post-intervention (4.5 months).
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Cardiovascular Risk
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%).
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Empowerment
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.
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Depressive Symptoms
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.
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Diabetes Knowledge
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.
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Dietary Habits
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
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Motivation and Attitudes Toward Changing Health
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.
Measured: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Nov 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care, University of Virginia
- Responsible party
- Sponsor
- Investigators
- Tamara Oser, MD, Principal investigator, Associate Professor, Dept. Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580978
- Sponsor's protocol ID
- 21-4931
- Acronym
- IMPEDE
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2022
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Libre 2 CGM Plus Glycemic Excursion mIniMization (GEM) in the Treatment of PrEDiabEtes
- ClinicalTrials.gov ID
- NCT05580978
- Acronym / sponsor ID
- IMPEDE / 21-4931
- Conditions
- PreDiabetes
- Keywords
- prediabetes, lifestyle guide, continuous glucose monitor, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care, University of Virginia
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEM + CGM + Activity Monitor | Experimental | Behavioral: GEMGEM plus CGM and Activity Monitor (FitBit) |
| Routine Care | Active comparator | Other: Routine CareUsual care already being received for prediabetes as treated by their care team. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEMThe 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. | Behavioural | GEM + CGM + Activity Monitor |
| Routine CareParticipant's current prediabetes treatment. | Other | Routine Care |
Primary outcome
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.
9 secondary outcomes
Change in HbA1c
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Glucose Variability
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Body Mass Index
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Cardiovascular Risk
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Empowerment
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Depressive Symptoms
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Change in Diabetes Knowledge
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Dietary Habits
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Motivation and Attitudes Toward Changing Health
Time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Oser, MD principal investigator
Associate Professor, Dept. Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEM and Routine Care in people with PreDiabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of CGM Glucose Readings > 120 mg/dL (time frame: Pre-Intervention (Baseline) to post Intervention (4.5 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.