Trial Outcomes & Findings for Continuous Glucose Monitoring in Prediabetes (NCT NCT06472297)
NCT ID: NCT06472297
Last Updated: 2026-01-30
Results Overview
Mean glucose was derived from continuous glucose monitoring (CGM) data obtained from the Dexcom Clarity system. Raw glucose values were processed and analyzed using the R statistical software package iglu to generate the full CGM variability metrics panel. For each participant, mean glucose was calculated separately for each 10-day assessment period. The outcome measure represents the change in mean glucose, defined as the difference between the baseline (Phase A) 10-day assessment period and the subsequent (Phase B) 10-day assessment period.
COMPLETED
NA
23 participants
Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B).
2026-01-30
Participant Flow
Recruitment and preliminary screening activities occurred between 5/24/2024 and 8/30/2024, using baseline screening telephone calls. The Study Start Date of 6/1/2024 reflects the date on which the first participant was formally enrolled in the study. The target population included 20 community health workers who had been actively working within the past six months, were diagnosed with prediabetes, and primarily resided in Los Angeles County.
Participant milestones
| Measure |
Unmasked CGM Feedback (Single Study Arm)
The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Unmasked CGM Feedback (Single Study Arm)
The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Continuous Glucose Monitoring in Prediabetes
Baseline characteristics by cohort
| Measure |
Unmasked CGM Feedback (Single Study Arm)
n=23 Participants
The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.
|
|---|---|
|
Age, Continuous
|
50.0 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=41 Participants
|
|
Highest level of education
High School or Less
|
11 Participants
n=41 Participants
|
|
Highest level of education
Some College or Vocational Training
|
1 Participants
n=41 Participants
|
|
Highest level of education
College Degree or Higher
|
11 Participants
n=41 Participants
|
|
Current employment status
Employed
|
18 Participants
n=41 Participants
|
|
Current employment status
Unemployed
|
1 Participants
n=41 Participants
|
|
Current employment status
Retired
|
2 Participants
n=41 Participants
|
|
Current employment status
Homemaker
|
2 Participants
n=41 Participants
|
|
Current employment status
Student
|
0 Participants
n=41 Participants
|
|
Total household income
Less than $10,000
|
2 Participants
n=41 Participants
|
|
Total household income
$10,000 to $29,999
|
7 Participants
n=41 Participants
|
|
Total household income
$30,000 to $49,999
|
9 Participants
n=41 Participants
|
|
Total household income
$50,000 to $69,999
|
3 Participants
n=41 Participants
|
|
Total household income
$70,000 to $89,999
|
1 Participants
n=41 Participants
|
|
Total household income
$90,000 to $149,999
|
1 Participants
n=41 Participants
|
|
Total household income
$150,000 or more
|
0 Participants
n=41 Participants
|
|
Health insurance
Public
|
17 Participants
n=41 Participants
|
|
Health insurance
Private
|
5 Participants
n=41 Participants
|
|
Health insurance
Self-cash paying
|
1 Participants
n=41 Participants
|
|
Centers for Disease Control and Prevention (CDC) prediabetes risk score
Scored under 5
|
4 Participants
n=41 Participants
|
|
Centers for Disease Control and Prevention (CDC) prediabetes risk score
Scored 5 or higher
|
19 Participants
n=41 Participants
|
|
Body Mass Index
|
31.8 kg/m²
n=41 Participants
|
|
Physical Activity Level (International Physical Activity Questionnaire [IPAQ])
Low
|
6 Participants
n=41 Participants
|
|
Physical Activity Level (International Physical Activity Questionnaire [IPAQ])
Moderate
|
7 Participants
n=41 Participants
|
|
Physical Activity Level (International Physical Activity Questionnaire [IPAQ])
High
|
10 Participants
n=41 Participants
|
|
HbA1c (%)
HbA1c < 5.7%
|
11 Participants
n=41 Participants
|
|
HbA1c (%)
HbA1c ≥ 5.7%
|
12 Participants
n=41 Participants
|
|
Self-reported history of prediabetes
Yes
|
14 Participants
n=41 Participants
|
|
Self-reported history of prediabetes
No
|
9 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B).Population: Participants included in the analysis had sufficient continuous glucose monitoring (CGM) data. Inclusion required at least 2 days of valid CGM data within each 10-day assessment period. Three participants were excluded: two withdrew before completion of data collection, and one was later deemed ineligible based on protocol criteria identified after enrollment. Primary outcome analyses were therefore conducted on 20 participants.
Mean glucose was derived from continuous glucose monitoring (CGM) data obtained from the Dexcom Clarity system. Raw glucose values were processed and analyzed using the R statistical software package iglu to generate the full CGM variability metrics panel. For each participant, mean glucose was calculated separately for each 10-day assessment period. The outcome measure represents the change in mean glucose, defined as the difference between the baseline (Phase A) 10-day assessment period and the subsequent (Phase B) 10-day assessment period.
Outcome measures
| Measure |
Unmasked CGM Feedback (Single Study Arm)
n=20 Participants
The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.
|
|---|---|
|
Change in Mean Glucose (mg/dL) From Baseline
|
2.1 mg/dL
Interval -7.4 to 9.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 20 days during the CGM wear period, plus post-study interview recordings.Population: All participants that provided at least 1 video.
Total duration, in minutes, of narrative video recordings generated by participants, including daily selfie-style reflections recorded during the continuous glucose monitor (CGM) wear period and post-study interview recordings (as a measure of feasibility). The total number of minutes of recorded narrative video content was calculated by summing the duration of all daily reflection videos and post-study interview recordings across participants. Results are reported as total minutes.
Outcome measures
| Measure |
Unmasked CGM Feedback (Single Study Arm)
n=21 Participants
The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.
|
|---|---|
|
Total Duration of Participant-Generated Narrative Video Recordings
|
723 minutes
|
Adverse Events
Unmasked CGM Feedback (Single Study Arm)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Unmasked CGM Feedback (Single Study Arm)
n=23 participants at risk
The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Sensor site pain
|
13.0%
3/23 • From participant enrollment through end of study follow-up (20 days)
|
|
Skin and subcutaneous tissue disorders
Sensor site itching
|
4.3%
1/23 • From participant enrollment through end of study follow-up (20 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place