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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM, nutrition and exercise education, participants will be able to monitor their blood sugar in real time for 2 sessions . Education on how to interpret CGM in the setting of food choices and exercise coupled with nutrition and exercise information should lead to improved weight and other nutritional and exercise changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXCOM G6 RT-CGM | Active Comparator | 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. |
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| Blinded CGM | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEXCOM G6 RT-CGM | Device | CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in BMI From Baseline to 14 Weeks | weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks | 14 weeks |
| Percent Body Fat Change at 14 Weeks | Percent by Tanita scale | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes | 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 | 14 weeks |
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Inclusion Criteria:
Age 18-55
Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)
BMI ≥ 30 kg/m2
Willing to wear pedometer during study period
Able to walk 2 city blocks at baseline without assistance (self-reported)
Reading level at least 6th grade in English
Expected to remain in local community for at least 4 months
Either is not treated with or has been on a stable treatment regimen of any of the following medications for a minimum of 3 months prior to Visit 1 (Screening/Enrollment):
Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Ehrhardt, MD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GWU Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
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note study was closed early given covid so enrollement was 23 not 45 as in orginal protocol
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percent Change in BMI From Baseline to 14 Weeks | weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks | Posted | Mean | Standard Deviation | % change over 14 weeks | 14 weeks |
|
Adverse event data was collected for 14 weeks
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicole Ehrhardt | University of Washington Diabetes Institute | 202-741-3422 | nehrhard@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2018 | Oct 10, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2018 | Nov 4, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Mean Glucose Change at 14 Weeks | average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks | 14 weeks |
| Food Frequency Change in Score at 14 Weeks | Starting 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 | 14 weeks |
| Change in Minutes Walked Per Week at 14 Weeks | The 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 | 14 weeks |
| MAGE Mean Amplitude of Glycemic Excursion | this is calculation of variance of glucose for CGM | 14 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Percent Body Fat Change at 14 Weeks | Percent by Tanita scale | Posted | Mean | Standard Deviation | % change over 14 weeks | 14 weeks |
|
|
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| Secondary | Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes | 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 | All participants in the CGM Intervention group. Blinded group did not complete this survey | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
|
|
|
| Secondary | Mean Glucose Change at 14 Weeks | average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks | CGM average glucose(mg/dL) | Posted | Mean | Standard Deviation | % change over 14 weeks | 14 weeks |
|
|
|
| Secondary | Food Frequency Change in Score at 14 Weeks | Starting 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 | Posted | Median | 95% Confidence Interval | score on a scale | 14 weeks |
|
|
|
| Secondary | Change in Minutes Walked Per Week at 14 Weeks | The 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 | Posted | Mean | Standard Deviation | minutes walked per week | 14 weeks |
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|
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| Secondary | MAGE Mean Amplitude of Glycemic Excursion | this is calculation of variance of glucose for CGM | Posted | Mean | Standard Deviation | mg/100ml | 14 weeks |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |