Trial Outcomes & Findings for Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes (NCT NCT03844646)
NCT ID: NCT03844646
Last Updated: 2023-01-31
Results Overview
Weight lost during the study
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline to end of study (3 months)
Results posted on
2023-01-31
Participant Flow
Participant milestones
| Measure |
CGM Plus Dietitian
Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian.
|
Dietitian Only
Monthly support meetings with a dietitian.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes
Baseline characteristics by cohort
| Measure |
CGM Plus Dietitian
n=8 Participants
Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian.
|
Dietitian Only
n=4 Participants
Monthly support meetings with a dietitian.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NonHispanic White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (3 months)Weight lost during the study
Outcome measures
| Measure |
CGM Plus Dietitian
n=8 Participants
Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian.
|
Dietitian Only
n=4 Participants
Monthly support meetings with a dietitian.
|
|---|---|---|
|
Amount of Weight Lost (kg)
Baseline
|
77.4 kg
Standard Deviation 8.4
|
74.9 kg
Standard Deviation 7.5
|
|
Amount of Weight Lost (kg)
Change at month 3
|
-2.9 kg
Standard Deviation 4.0
|
-3.1 kg
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline to end of study (3 months)Outcome measures
| Measure |
CGM Plus Dietitian
n=8 Participants
Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian.
|
Dietitian Only
n=4 Participants
Monthly support meetings with a dietitian.
|
|---|---|---|
|
Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More
|
4 Participants
|
2 Participants
|
Adverse Events
CGM Plus Dietitian
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dietitian 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