Trial Outcomes & Findings for Diabetes Education With Real-time Continuous Glucose Monitoring (NCT NCT05394844)
NCT ID: NCT05394844
Last Updated: 2025-12-01
Results Overview
Percent change in A1C
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
change at 12 weeks
Results posted on
2025-12-01
Participant Flow
Participant milestones
| Measure |
CGM With DM Education
if you are in the intervention group you will received culturally tailored diabetes education and use a Real Time CGM device to see your glucose over 12 weeks. Both group will completed blinded CGM at the beginning of the study and at 24 weeks
Dexcom G6: Dexcom G6 CGM device
|
Education Only
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
59
|
|
Overall Study
COMPLETED
|
45
|
40
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diabetes Education With Real-time Continuous Glucose Monitoring
Baseline characteristics by cohort
| Measure |
CGM With DM Education
n=61 Participants
if you are in the intervention group you will received culturally tailored diabetes education and use a Real Time CGM device to see your glucose over 12 weeks. Both group will completed blinded CGM at the beginning of the study and at 24 weeks
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=59 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 9 • n=121 Participants
|
47 years
STANDARD_DEVIATION 7 • n=122 Participants
|
46 years
STANDARD_DEVIATION 8 • n=243 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=121 Participants
|
24 Participants
n=122 Participants
|
53 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=121 Participants
|
35 Participants
n=122 Participants
|
67 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
61 Participants
n=121 Participants
|
59 Participants
n=122 Participants
|
120 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=121 Participants
|
59 participants
n=122 Participants
|
120 participants
n=243 Participants
|
|
income less than 49,999
|
35 participants
n=121 Participants
|
39 participants
n=122 Participants
|
74 participants
n=243 Participants
|
|
preferred primary language spanish
|
59 participants
n=121 Participants
|
58 participants
n=122 Participants
|
117 participants
n=243 Participants
|
|
education highschool or less
|
55 participants
n=121 Participants
|
54 participants
n=122 Participants
|
109 participants
n=243 Participants
|
|
insurance- self pay
|
44 Participants
n=121 Participants
|
36 Participants
n=122 Participants
|
80 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: change at 12 weeksPopulation: change in A1c over 12 weeks
Percent change in A1C
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Hemoglobin A1C
|
-2.3 percent change in A1C
Interval -3.1 to -1.5
|
-1.5 percent change in A1C
Interval -2.3 to -0.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: those that had baseline and 12 week CGM data
mean glucose at 12 weeks
Outcome measures
| Measure |
CGM With DM Education Household Member
n=45 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=38 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
CGM Mean Glucose
|
208.4 mg/dl
Standard Deviation 62.5
|
239.6 mg/dl
Standard Deviation 84.4
|
SECONDARY outcome
Timeframe: 12 WEEKSPopulation: THOSE WITH CGM DATA AVAILABLE AT 12 WEEKS
percentage of time in range( tir)
Outcome measures
| Measure |
CGM With DM Education Household Member
n=45 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=38 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
CGM Percentage of Time in Range
|
13.2 percentage of tir
Interval 1.3 to 25.2
|
6.2 percentage of tir
Interval -6.7 to 19.1
|
SECONDARY outcome
Timeframe: change at 12 WEEKSPopulation: THOSE WITH 12 WEEKS BMI AVAILABLE
percent change BMI ((kg/m2)
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Percent Change in BMI
|
-1 % bmi CHANGE
Interval -6.6 to 8.6
|
-2.4 % bmi CHANGE
Interval -10.0 to 5.3
|
SECONDARY outcome
Timeframe: change at 12 WEEKSPopulation: those with blood pressure available 12 weeks
change in blood pressure
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Blood Pressure Systolic
|
-2.5 mmHg
Interval -9.3 to 4.4
|
-0.3 mmHg
Interval -7.2 to 6.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: THOSE WITH questionnaire Available 12 weeks
increase or decrease in days of vigorous activity - one question in IPAQ.
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Physical Activity Questionnaire IPAQ
|
1 number of days
Standard Deviation 3.8
|
0.14 number of days
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: baselinePopulation: those that completed survey and felt bad or fairly bad about neighborhood
Question Neighborhood Questionnaire/Neighborhood Safety questions 1 1\. In general, how do you feel about your neighborhood? Do you feel it's a very bad, a fairly bad, a fairly good, or a very good place to live? reported number that felt it was very bad or fairly bad
Outcome measures
| Measure |
CGM With DM Education Household Member
n=61 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=58 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: those that completed questionnaire are 12 weeks
Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
PHQ9 Depression Score- Those With PHQ9>15
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: score at 12 weeksPopulation: those with questionnaire available at 12 weeks
the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
PAID-5 Problem Areas in Diabetes Those With Score > 8
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: composite score at 12 weeksPopulation: those with questionnaire available at 12 weeks
The Summary of Diabetes Self-Care Activities asks patient about diabetes self-care activities during the past 7 days and for each activity they can answer 0 days out of the week to a max of 7 days out of the week with higher score indicating more days doing this self -care activity and positive results
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care
|
5.3 days
Standard Deviation 2.04
|
3.3 days
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: participant who completed questionnaire and wore real-time CGM
Experiences of CGM @Joslin 2009 scale range from 5 (strongly agree) to 1 ( strongly disagree) statements/questions that measured the amount of satisfaction that was derived from use of continuous glucose monitoring. Higher score meant perceived benefit/ better outcome
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Modified Joslin Diabetes Center CGM Experience
|
4.33 score on a scale
Standard Deviation 0.55
|
—
|
SECONDARY outcome
Timeframe: at 12 weeksPopulation: particpants who completed questionnaire
Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes
Outcome measures
| Measure |
CGM With DM Education Household Member
n=37 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Perception of Behavior Modification After Real-Time- CGM Use
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: number of household members that completed the survey
household members perception of lifestyle changes after family member participated in education with CGM. Overall, do you feel Continuous Glucose Monitoring contributed to your making changes for a healthier lifestyle? yes
Outcome measures
| Measure |
CGM With DM Education Household Member
n=15 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Household/Family Member Perception of Lifestyle Changes
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: at 12 weeksPopulation: those that had pedometry data at 12 weeks
average number of steps per day
Outcome measures
| Measure |
CGM With DM Education Household Member
n=14 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=14 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Pedometer
|
6931 number of steps per day
Standard Deviation 3680
|
4703 number of steps per day
Standard Deviation 1567
|
SECONDARY outcome
Timeframe: score at 12 weeksPopulation: those that completed survey at 12 weeks
the scale is 1-10 and the score is the mean of the eight items. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy
Outcome measures
| Measure |
CGM With DM Education Household Member
n=41 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=40 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Self-Efficacy for Diabetes
|
8.5 units on a scale
Standard Deviation 1.4
|
7.7 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: baselinePopulation: those that completed survey
number of participants that had high or marginal food security based on 6 questions (geared to assess access or lack of access to food) composite score
Outcome measures
| Measure |
CGM With DM Education Household Member
n=61 Participants
intervention group household member received culturally tailored diabetes education and used a Real Time CGM device to see your glucose over 12 weeks.
Dexcom G6: Dexcom G6 CGM device
|
Education Only
n=58 Participants
If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks
|
|---|---|---|
|
Food Insecurity Short Form 6 Question Composite With Score Reported as a Composite: High or Marginal Food Security, Low Food Security, Very Low Food Security
|
30 Participants
|
37 Participants
|
Adverse Events
CGM With DM Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education Only
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