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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK116074 | U.S. NIH Grant/Contract | View source |
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COVID-19
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM plus dietitian | Experimental | Intermittent use of a continuous glucose monitor (CGM) plus dietitian support |
|
| Dietitian only | Other | Dietitian support only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM | Device | Intermittent use of a continuous glucose monitor (CGM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Weight Lost (kg) | Weight lost during the study | Baseline to end of study (3 months) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Kim, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Plus Dietitian | Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian. |
| FG001 | Dietitian Only | Monthly support meetings with a dietitian. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Plus Dietitian | Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian. |
| BG001 | Dietitian Only | Monthly support meetings with a dietitian. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amount of Weight Lost (kg) | Weight lost during the study | Posted | Mean | Standard Deviation | kg | Baseline to end of study (3 months) |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM Plus Dietitian | Intermittent use of a continuous glucose monitor (CGM) plus monthly support meetings with a dietitian. |
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This study did not achieve its planned sample size and is underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun H. Kim, MD, MS | Stanford University | 650-723-8284 | sunhkim@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2019 | Jan 12, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064686 | Nutritionists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Dietitian |
| Other |
Monthly meetings with a dietitian |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More | Posted | Count of Participants | Participants | Baseline to end of study (3 months) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Dietitian Only | Monthly support meetings with a dietitian. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |