Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott Diabetes Care | INDUSTRY |
| University of Virginia | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEM + CGM + Activity Monitor | Experimental | GEM plus CGM and Activity Monitor (FitBit) |
|
| Routine Care | Active Comparator | Usual care already being received for prediabetes as treated by their care team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from pre-intervention (baseline) to post-intervention (4.5 months). | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
| Change in Glucose Variability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tamara Oser, MD | Associate Professor, Dept. Family Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado- Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
24 participants did not meet inclusion criteria after enrollment. Two participants withdrew prior to randomization. In total, 35 participants were randomized.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GEM + CGM + Activity Monitor Only (4.5 Months). | Participants assigned by randomization to undergo 4.5 months of GEM + CGM + Activity Monitor. These participants did not have the option to cross-over. |
| FG001 | Routine Care First (4.5 Months), Then GEM + CGM + Activity Monitor (4.5 Months) | Cross-over participants assigned by randomization to undergo 4.5 months of Routine Care, followed by 4.5 months of GEM + CGM + Activity Monitor. There was no washout period between arms. Routine Care: 4.5 months of the participant's usual care of their prediabetes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline demographic information for participants who completed "GEM + CGM + Activity Monitor Only" and "Routine Care First, then GEM + CGM + Activity Monitor" arms.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GEM + CGM + Activity Monitor Only (4.5 Months). | Participants assigned by randomization to undergo 4.5 months of GEM + CGM + Activity Monitor. These participants did not have the option to cross-over. |
| BG001 | Routine Care First (4.5 Months), Then GEM + CGM + Activity Monitor (4.5 Months) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. There was insufficient data to include in analysis for 3 participants. | Posted | Mean | Standard Deviation | percentage of CGM readings | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
From enrollment until end of RCT, up to 4.5 months for the intervention group (RC + GEM + Fitbit) and up to 9 months for the RC cross-over group.
Adverse event means any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). Adverse events will be recorded in the participant Case Report Form. Adverse events will be described by duration (start and stop dates), severity, outcome, treatment and relation to study intervention, or if unrelated, the cause.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GEM + CGM + Activity Monitor | GEM plus CGM and Activity Monitor (FitBit) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Torn ACL | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Oser | University of Colorado Anschutz Medical Campus | 303-724-2060 | tamara.oser@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2023 | Nov 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2023 | Nov 25, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Routine Care | Other | Participant's current prediabetes treatment. |
|
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).
| 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). | 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%). | 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. | 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. | 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. | 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 | 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. | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
Cross-over participants assigned by randomization to undergo 4.5 months of Routine Care, followed by 4.5 months of GEM + CGM + Activity Monitor. There was no washout period between arms. Routine Care: 4.5 months of the participant's usual care of their prediabetes. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Routine Care | Usual care already being received for prediabetes as treated by their care team. |
|
|
| Secondary | Change in HbA1c | Change in HbA1c from pre-intervention (baseline) to post-intervention (4.5 months). | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. . | Posted | Mean | Standard Deviation | Percent (%) HbA1c | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | 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). | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. There was insufficient data to include in analysis for 3 participants. | Posted | Mean | Standard Deviation | Percent (%) Glucose Variability | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | Change in Body Mass Index | Change in Body Mass Index (BMI) from pre-intervention (baseline) to post-intervention (4.5 months). | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. There was insufficient data to include in analysis for 1 participant. | Posted | Mean | Standard Deviation | kilograms per meter squared (kg/m²) | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | 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%). | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. The function will not calculate if values are above or below certain ranges (n=20 records). | Posted | Mean | Standard Deviation | Percent (%) | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | 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. | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. There was insufficient data to include in analysis for 1 participant. | Posted | Mean | Standard Deviation | scores on a scale | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | 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. | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. | Posted | Mean | Standard Deviation | scores on a scale | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | 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. | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. There was insufficient data to include in analysis for 1 participant. | Posted | Mean | Standard Deviation | Percent (%) Correct | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | 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 | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. | Posted | Mean | Standard Deviation | scores on a scale | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| Secondary | 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. | Thirty-three participants completed the study; 21 completed Routine Care and 12 completed GEM + CGM + Activity. 15 participants were eligible to cross over from the Routine Care group to the GEM + CGM + Activity Monitor group after completing Routine Care. One participant who crossed over to the GEM + CGM + Activity Monitor group was lost to follow-up. In total 26 completed GEM + CGM + Activity Monitor. | Posted | Mean | Standard Deviation | scores on a scale | Pre-Intervention (Baseline) to post Intervention (4.5 Months) |
|
|
|
| 29 |
| 2 |
| 29 |
| 5 |
| 29 |
| EG001 | Routine Care | Usual care already being received for prediabetes as treated by their care team. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Routine Care - Between Arms | Participants who completed the routine care arm who were eligible and interested in crossing over to the GEM + CGM + Activity Monitor arm, but did not yet start the CGM + Activity Monitor arm. | 0 | 15 | 0 | 15 | 1 | 15 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hip replacement | Surgical and medical procedures | Systematic Assessment |
|
| Chondrocalcinosis (pseudo gout) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Surgical repair (right hip) | Surgical and medical procedures | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |