Trial Outcomes & Findings for Continuous Glucose Monitoring in Diabetes and Prediabetes (NCT NCT03805412)
NCT ID: NCT03805412
Last Updated: 2023-03-01
Results Overview
weight and height will be combined to report % change BMI in kg/m\^2 at 14 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
14 weeks
Results posted on
2023-03-01
Participant Flow
note study was closed early given covid so enrollement was 23 not 45 as in orginal protocol
Participant milestones
| Measure |
DEXCOM G6 RT-CGM
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
DEXCOM G6 RT-CGM
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Continuous Glucose Monitoring in Diabetes and Prediabetes
Baseline characteristics by cohort
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
n=8 Participants
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Participants were between the ages of 18 and 55 years old
|
15 years
n=5 Participants
|
8 years
n=7 Participants
|
23 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeksweight and height will be combined to report % change BMI in kg/m\^2 at 14 weeks
Outcome measures
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
n=7 Participants
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Percent Change in BMI From Baseline to 14 Weeks
|
-0.3 % change over 14 weeks
Standard Deviation 0.5
|
-0.2 % change over 14 weeks
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 14 weeksPercent by Tanita scale
Outcome measures
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
n=7 Participants
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Percent Body Fat Change at 14 Weeks
|
1.7 % change over 14 weeks
Standard Deviation 3.5
|
-1.6 % change over 14 weeks
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: All participants in the CGM Intervention group. Blinded group did not complete this survey
Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score
Outcome measures
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes
|
75.8 score on a scale
Standard Deviation 9.3
|
—
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: CGM average glucose(mg/dL)
average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks
Outcome measures
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
n=7 Participants
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Mean Glucose Change at 14 Weeks
|
-0.3 % change over 14 weeks
Standard Deviation 28.9
|
23.0 % change over 14 weeks
Standard Deviation 61.9
|
SECONDARY outcome
Timeframe: 14 weeksStarting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices
Outcome measures
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
n=7 Participants
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Food Frequency Change in Score at 14 Weeks
|
-2.0 score on a scale
Interval -2.8 to 0.2
|
0 score on a scale
Interval -1.2 to 1.6
|
SECONDARY outcome
Timeframe: 14 weeksThe International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting
Outcome measures
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
n=7 Participants
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
Change in Minutes Walked Per Week at 14 Weeks
|
438.8 minutes walked per week
Standard Deviation 535.4
|
232.0 minutes walked per week
Standard Deviation 343.6
|
SECONDARY outcome
Timeframe: 14 weeksthis is calculation of variance of glucose for CGM
Outcome measures
| Measure |
DEXCOM G6 RT-CGM
n=15 Participants
These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
|
Blinded CGM
n=7 Participants
These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
|
|---|---|---|
|
MAGE Mean Amplitude of Glycemic Excursion
|
95.1 mg/100ml
Standard Deviation 32.3
|
90.1 mg/100ml
Standard Deviation 85.9
|
Adverse Events
DEXCOM G6 RT-CGM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blinded CGM
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
Dr. Nicole Ehrhardt
University of Washington Diabetes Institute
Phone: 202-741-3422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place