PreDiabetes, Weight Loss
Conditions
Brief summary
The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.
Detailed description
Continuous glucose monitoring (CGM) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. Successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. This proposal will test the hypothesis that intermittent CGM will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.
Interventions
DEVICECGM
Intermittent use of a continuous glucose monitor (CGM)
OTHERDietitian
Monthly meetings with a dietitian
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight/obese (BMI 25-40 kg/m2) * Prediabetes (fasting glucose 100-125 mg/dL and/or HbA1c 5.7-6.4%)
Exclusion criteria
* On glucose-lowering medications (e.g., metformin) * On weight-loss medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Weight Lost (kg) | Baseline to end of study (3 months) | Weight lost during the study |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More | Baseline to end of study (3 months) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CGM Plus Dietitian Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian. | 8 |
| Dietitian Only Monthly support meetings with a dietitian. | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | Total | Dietitian Only | CGM Plus Dietitian |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized NonHispanic White | 5 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 12 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 0 / 8 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 4 |
Outcome results
Primary
Amount of Weight Lost (kg)
Weight lost during the study
Time frame: Baseline to end of study (3 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM Plus Dietitian | Amount of Weight Lost (kg) | Baseline | 77.4 kg | Standard Deviation 8.4 |
| CGM Plus Dietitian | Amount of Weight Lost (kg) | Change at month 3 | -2.9 kg | Standard Deviation 4 |
| Dietitian Only | Amount of Weight Lost (kg) | Baseline | 74.9 kg | Standard Deviation 7.5 |
| Dietitian Only | Amount of Weight Lost (kg) | Change at month 3 | -3.1 kg | Standard Deviation 0.6 |
Secondary
Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More
Time frame: Baseline to end of study (3 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM Plus Dietitian | Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More | 4 Participants |
| Dietitian Only | Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More | 2 Participants |