Trial Outcomes & Findings for Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes (NCT NCT05505565)
NCT ID: NCT05505565
Last Updated: 2026-06-17
Results Overview
Caregiver and patient acceptability of CGM use
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
6 months
Results posted on
2026-06-17
Participant Flow
There were a total of 33 active subjects recruited. 21 youth in the intervention arm and 12 in the control arm. Caregivers of the 21 youth randomized to the intervention arm were enrolled to provide caregiver feedback in the form of surveys on their impression of continuous glucose monitor use.
There were a total of 33 active subjects recruited. 21 youth in the intervention arm and 12 in the control arm. Caregivers of the 21 youth randomized to the intervention arm were enrolled to provide caregiver feedback in the form of surveys on their impression of continuous glucose monitor use. Caregiver's provided survey data only. Demographic data on caregivers was not collected.
Participant milestones
| Measure |
Control
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
CGM + Traditional Counseling
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Caregivers of CGM+Traditional Counseling Group
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
21
|
21
|
|
Overall Study
COMPLETED
|
8
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
Baseline characteristics by cohort
| Measure |
CGM + Traditional Counseling
n=21 Participants
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Control
n=12 Participants
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.2 Years
STANDARD_DEVIATION 1.9 • n=9 Participants
|
14.7 Years
STANDARD_DEVIATION 2.3 • n=27 Participants
|
14.4 Years
STANDARD_DEVIATION 2.1 • n=267 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Hemoglobin A1c
|
5.9 Percentage (%)
STANDARD_DEVIATION 0.3 • n=9 Participants
|
5.7 Percentage (%)
STANDARD_DEVIATION 0.3 • n=27 Participants
|
5.8 Percentage (%)
STANDARD_DEVIATION 0.3 • n=267 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 0 Control subjects included in analysis as this primary outcome was CGM acceptability. Of the 17 participant/caregiver pairs in the treatment group who returned for the final visit, only 15 answered question about whether or not they wanted to continue to use the device. 16 caregivers and 17 participants answered the question about the device "being more trouble than it is worth"
Caregiver and patient acceptability of CGM use
Outcome measures
| Measure |
CGM + Traditional Counseling
n=17 Participants
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Control
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Caregivers of CGM + Traditional Counseling
n=17 Participants
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
|
|---|---|---|---|
|
CGM Acceptability
Participant: The device is more trouble than it is worth · Disagree or Strongly Disagree
|
16 Participants
|
—
|
0 Participants
|
|
CGM Acceptability
Caregiver: The device is more trouble than it is worth · Disagree or Strongly Disagree
|
0 Participants
|
—
|
12 Participants
|
|
CGM Acceptability
Participant: The device is more trouble than it is worth · Agree or strongly agree
|
0 Participants
|
—
|
0 Participants
|
|
CGM Acceptability
Participant: The device is more trouble than it is worth · Neutral
|
1 Participants
|
—
|
0 Participants
|
|
CGM Acceptability
Caregiver: The device is more trouble than it is worth · Neutral
|
0 Participants
|
—
|
3 Participants
|
|
CGM Acceptability
Caregiver: "I want my child to use the device when the study is over." · Agree or strongly agree
|
0 Participants
|
0 Participants
|
13 Participants
|
|
CGM Acceptability
Caregiver: "I want my child to use the device when the study is over." · Neutral
|
0 Participants
|
0 Participants
|
2 Participants
|
|
CGM Acceptability
Caregiver: "I want my child to use the device when the study is over." · Disagree or Strongly Disagree
|
0 Participants
|
—
|
0 Participants
|
|
CGM Acceptability
Participant: "I want to use the device when the study is over" · Agree or strongly agree
|
10 Participants
|
—
|
0 Participants
|
|
CGM Acceptability
Participant: "I want to use the device when the study is over" · Neutral
|
3 Participants
|
—
|
0 Participants
|
|
CGM Acceptability
Participant: "I want to use the device when the study is over" · Disagree or Strongly Disagree
|
2 Participants
|
—
|
0 Participants
|
|
CGM Acceptability
Caregiver: The device is more trouble than it is worth · Agree or strongly agree
|
0 Participants
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe difference in measured percentage of glycosylated hemoglobin (hemoglobin A1c) was obtained by subtracting the 6-month value from the baseline value for all subjects with paired data available. A negative result indicates a reduction (improvement) in hemoglobin A1c over the period.
Outcome measures
| Measure |
CGM + Traditional Counseling
n=17 Participants
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Control
n=8 Participants
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Caregivers of CGM + Traditional Counseling
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
|
|---|---|---|---|
|
Change in Measured % HbA1c From Baseline to 6-months
|
0.0 Absolute change in measured HgbA1c %
Standard Deviation 0.2
|
0.2 Absolute change in measured HgbA1c %
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: 6 monthsHomeostatic model assessment of insulin resistance (HOMA-IR) at baseline and 6-month were calculated. HOMA-IR = fasting glucose (mg/dL) x fasting insulin (uIU/mL) / 405. Lower values indicate greater insulin sensitivity with values \>2.5 consistent with insulin resistance. The difference in 6-month from baseline was determined for all with paired data available. A negative result indicates a reduction (improvement) in HOMA-IR over the period.
Outcome measures
| Measure |
CGM + Traditional Counseling
n=17 Participants
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Control
n=8 Participants
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Caregivers of CGM + Traditional Counseling
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
|
|---|---|---|---|
|
Change in HOMA-IR From Baseline to 6-months.
|
4.97 Index
Standard Deviation 10.7
|
6.33 Index
Standard Deviation 11.4
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: While 17 CGM+Traditional counseling and 8 control subjects returned for the final visit, only 13 and 4 had cholesterol panels obtained.
Changes in measured triglycerides, HDL, LDL, and total cholesterol were calculated for all subjects with paired data available. A negative result indicates a reduction (improvement) in triglycerides, LDL, and total cholesterol over the period. A negative result indicates a reduction (worsening) of HDL over the same study period.
Outcome measures
| Measure |
CGM + Traditional Counseling
n=13 Participants
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Control
n=4 Participants
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Caregivers of CGM + Traditional Counseling
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
|
|---|---|---|---|
|
Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month
Change in triglycerides
|
-12 mg/dL
Standard Deviation 24
|
29 mg/dL
Standard Deviation 27
|
—
|
|
Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month
Change in total cholesterol
|
-9 mg/dL
Standard Deviation 12
|
6 mg/dL
Standard Deviation 20
|
—
|
|
Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month
Change in LDL
|
-8 mg/dL
Standard Deviation 9.2
|
-2 mg/dL
Standard Deviation 19
|
—
|
|
Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month
Change in HDL
|
0 mg/dL
Standard Deviation 7
|
1 mg/dL
Standard Deviation 2
|
—
|
SECONDARY outcome
Timeframe: 6 monthsAlanine transferase (ALT) and aspartate aminotransferase (AST) were measured at baseline and 6-months. A negative result indicated a decrease (improvement) in the value. While 17 CGM+Treatment subjects returned for the final visit, only 14 had liver enzymes measured. While 8 control subjects returned for the final visit, only 6 had liver enzymes measured.
Outcome measures
| Measure |
CGM + Traditional Counseling
n=14 Participants
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Control
n=6 Participants
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Caregivers of CGM + Traditional Counseling
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
|
|---|---|---|---|
|
Changes in Liver Enzymes From Baseline to 6-months.
Change in ALT
|
-0.6 U/L
Standard Deviation 11.3
|
-2.5 U/L
Standard Deviation 11.8
|
—
|
|
Changes in Liver Enzymes From Baseline to 6-months.
Change in AST
|
-0.3 U/L
Standard Deviation 6.7
|
-2.2 U/L
Standard Deviation 14.5
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: While 22 were randomized to this arm, only 6 had CGM data available for Baseline and Final (6-month) visit. Data for these 6 are presented here.
CGM metrics collected included the percentage of time in the target range and percentage of time with glucose \>140mg/dL.
Outcome measures
| Measure |
CGM + Traditional Counseling
n=6 Participants
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Control
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
|
Caregivers of CGM + Traditional Counseling
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
|
|---|---|---|---|
|
Glycemic Metrics
Baseline Percentage Time in Range
|
94.6 Percentage of time spent in the range
Standard Deviation 0.05
|
—
|
—
|
|
Glycemic Metrics
6-month Percentage Time in Range
|
93.4 Percentage of time spent in the range
Standard Deviation 0.03
|
—
|
—
|
|
Glycemic Metrics
Baseline Percentage Time >140mg/dL
|
2.2 Percentage of time spent in the range
Standard Deviation 0.03
|
—
|
—
|
|
Glycemic Metrics
6-month Percentage Time >140mg/L
|
4.2 Percentage of time spent in the range
Standard Deviation 0.05
|
—
|
—
|
Adverse Events
CGM + Traditional Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place