Trial Outcomes & Findings for CGM Plus GEM in Prediabetes (NCT NCT05580978)
NCT ID: NCT05580978
Last Updated: 2026-06-03
Results Overview
Change in percentage of CGM glucose readings \> 120 mg/dL from pre-intervention (baseline) blinded CGM to post-intervention (4.5 months) blinded CGM.
COMPLETED
NA
61 participants
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
2026-06-03
Participant Flow
24 participants did not meet inclusion criteria after enrollment. Two participants withdrew prior to randomization. In total, 35 participants were randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
21
|
|
Overall Study
COMPLETED
|
12
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CGM Plus GEM in Prediabetes
Baseline characteristics by cohort
| Measure |
GEM + CGM + Activity Monitor Only (4.5 Months).
n=14 Participants
Participants assigned by randomization to undergo 4.5 months of GEM + CGM + Activity Monitor. These participants did not have the option to cross-over.
|
Routine Care First (4.5 Months), Then GEM + CGM + Activity Monitor (4.5 Months)
n=21 Participants
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.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 11.9 • n=20 Participants
|
58.6 Years
STANDARD_DEVIATION 10.3 • n=20 Participants
|
58.6 Years
STANDARD_DEVIATION 10.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
Change in percentage of CGM glucose readings \> 120 mg/dL from pre-intervention (baseline) blinded CGM to post-intervention (4.5 months) blinded CGM.
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=23 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in Percentage of CGM Glucose Readings > 120 mg/dL
Pre Intervention
|
25.0 percentage of CGM readings
Standard Deviation 18.3
|
21.5 percentage of CGM readings
Standard Deviation 18.1
|
|
Change in Percentage of CGM Glucose Readings > 120 mg/dL
Post Intervention
|
16.9 percentage of CGM readings
Standard Deviation 18.4
|
21.7 percentage of CGM readings
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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. .
Change in HbA1c from pre-intervention (baseline) to post-intervention (4.5 months).
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=26 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in HbA1c
Pre Intervention
|
6.2 Percent (%) HbA1c
Standard Deviation 0.1
|
6.2 Percent (%) HbA1c
Standard Deviation 0.2
|
|
Change in HbA1c
Post Intervention
|
6.0 Percent (%) HbA1c
Standard Deviation 0.3
|
6.1 Percent (%) HbA1c
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
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).
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=23 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in Glucose Variability
Pre Intervention
|
18.6 Percent (%) Glucose Variability
Standard Deviation 4.3
|
18.4 Percent (%) Glucose Variability
Standard Deviation 4.3
|
|
Change in Glucose Variability
Post Intervention
|
16.6 Percent (%) Glucose Variability
Standard Deviation 3.5
|
19.2 Percent (%) Glucose Variability
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
Change in Body Mass Index (BMI) from pre-intervention (baseline) to post-intervention (4.5 months).
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=25 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in Body Mass Index
Post Intervention
|
29.2 kilograms per meter squared (kg/m²)
Standard Deviation 6.6
|
30.3 kilograms per meter squared (kg/m²)
Standard Deviation 7.7
|
|
Change in Body Mass Index
Pre Intervention
|
30.7 kilograms per meter squared (kg/m²)
Standard Deviation 6.6
|
30.8 kilograms per meter squared (kg/m²)
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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).
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%).
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=15 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=12 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in Cardiovascular Risk
Pre Intervention
|
5.6 Percent (%)
Standard Deviation 4.5
|
5.2 Percent (%)
Standard Deviation 3.6
|
|
Change in Cardiovascular Risk
Post Intervention
|
6.0 Percent (%)
Standard Deviation 4.8
|
5.1 Percent (%)
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
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.
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=26 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=20 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in Empowerment
Post Intervention
|
36.6 scores on a scale
Standard Deviation 5.6
|
32.8 scores on a scale
Standard Deviation 5
|
|
Change in Empowerment
Pre Intervention
|
32.8 scores on a scale
Standard Deviation 5.3
|
30.4 scores on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
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.
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=26 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in Depressive Symptoms
Pre Intervention
|
2.6 scores on a scale
Standard Deviation 2.3
|
3.5 scores on a scale
Standard Deviation 2.5
|
|
Change in Depressive Symptoms
Post Intervention
|
2.0 scores on a scale
Standard Deviation 2.1
|
3.2 scores on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
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.
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=26 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=20 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Change in Diabetes Knowledge
Post Intervention
|
74.5 Percent (%) Correct
Standard Deviation 7.2
|
62.8 Percent (%) Correct
Standard Deviation 8.6
|
|
Change in Diabetes Knowledge
Pre Intervention
|
61.9 Percent (%) Correct
Standard Deviation 8.1
|
62.8 Percent (%) Correct
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
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
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=26 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Dietary Habits
Pre Intervention
|
32.5 scores on a scale
Standard Deviation 19.8
|
29.4 scores on a scale
Standard Deviation 18.2
|
|
Dietary Habits
Post Intervention
|
18.8 scores on a scale
Standard Deviation 20.3
|
33.8 scores on a scale
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: Pre-Intervention (Baseline) to post Intervention (4.5 Months)Population: 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.
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.
Outcome measures
| Measure |
GEM + CGM + Activity Monitor
n=26 Participants
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 Participants
Usual care already being received for prediabetes as treated by their care team.
|
|---|---|---|
|
Motivation and Attitudes Toward Changing Health
Pre Intervention
|
4.58 scores on a scale
Standard Deviation 0.4
|
4.57 scores on a scale
Standard Deviation 0.37
|
|
Motivation and Attitudes Toward Changing Health
Post Intervention
|
4.57 scores on a scale
Standard Deviation 0.41
|
4.63 scores on a scale
Standard Deviation 0.44
|
Adverse Events
GEM + CGM + Activity Monitor
Routine Care
Routine Care - Between Arms
Serious adverse events
| Measure |
GEM + CGM + Activity Monitor
n=29 participants at risk
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 participants at risk
Usual care already being received for prediabetes as treated by their care team.
|
Routine Care - Between Arms
n=15 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diverticulitis
|
3.4%
1/29 • 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.
|
0.00%
0/21 • 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.
|
0.00%
0/15 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.4%
1/29 • 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.
|
0.00%
0/21 • 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.
|
0.00%
0/15 • 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.
|
Other adverse events
| Measure |
GEM + CGM + Activity Monitor
n=29 participants at risk
GEM plus CGM and Activity Monitor (FitBit)
|
Routine Care
n=21 participants at risk
Usual care already being received for prediabetes as treated by their care team.
|
Routine Care - Between Arms
n=15 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Torn ACL
|
0.00%
0/29 • 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.
|
0.00%
0/21 • 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.
|
6.7%
1/15 • 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.
|
|
Surgical and medical procedures
Hip replacement
|
3.4%
1/29 • 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.
|
0.00%
0/21 • 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.
|
0.00%
0/15 • 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.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis (pseudo gout)
|
3.4%
1/29 • 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.
|
0.00%
0/21 • 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.
|
0.00%
0/15 • 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.
|
|
Musculoskeletal and connective tissue disorders
Knee injury
|
3.4%
1/29 • 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.
|
0.00%
0/21 • 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.
|
0.00%
0/15 • 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.
|
|
Surgical and medical procedures
Surgical repair (right hip)
|
3.4%
1/29 • 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.
|
0.00%
0/21 • 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.
|
0.00%
0/15 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
1/29 • 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.
|
0.00%
0/21 • 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.
|
0.00%
0/15 • 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.
|
Additional Information
Tamara Oser
University of Colorado Anschutz Medical Campus
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place