Diabetes Mellitus, Type 2, Obesity, PreDiabetes
Conditions
Brief summary
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.
Interventions
DEVICEDEXCOM G6 RT-CGM
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.
Sponsors
DexCom, Inc.
Nicole Ehrhardt, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-55 2. Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10) 3. BMI ≥ 30 kg/m2 4. Willing to wear pedometer during study period 5. Able to walk 2 city blocks at baseline without assistance (self-reported) 6. Reading level at least 6th grade in English 7. Expected to remain in local community for at least 4 months 8. 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): 1. Sulfonylureas 2. Biguanidine 3. Thyroid replacement therapy 4. Glp-1 agonists 5. Sodium-glucose co-transporters 6. Basal insulin 7. Thiazolidinediones 8. Hormone replacement therapy (female subjects) estrogen/progesterone products 9. Oral contraceptives/birth control (female subjects) 10. Antidepressant agents (SSRIs, Paxil, Prozac, Celexa, Zoloft, etc.) 9. 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
1. Women who are pregnant, lactating, planning to become pregnant 2. Subjects who are taking amphetamines, anabolic, or weight-reducing agents 3. Contraindications to moderate exercise 4. Pre-prandial insulin 5. On any antipsychotic medication or history of schizophrenia or bipolar disorder 6. Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months 7. Active wounds or recent surgery within 3 months 8. Inflammatory disease, or chronic and current use of anti-inflammatory drugs or narcotics 9. Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study 10. Presence or history of severe congestive heart failure (New York Heart Association Class IV \[CCNYHA 1994\]) 11. Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant 12. Enrolled in another weight loss program 13. Already receiving continuous glucose monitoring (CGM)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in BMI From Baseline to 14 Weeks | 14 weeks | weight and height will be combined to report % change BMI in kg/m\^2 at 14 weeks |
| Percent Body Fat Change at 14 Weeks | 14 weeks | Percent by Tanita scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Frequency Change in Score at 14 Weeks | 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 |
| Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes | 14 weeks | 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 |
| MAGE Mean Amplitude of Glycemic Excursion | 14 weeks | this is calculation of variance of glucose for CGM |
| Change in Minutes Walked Per Week at 14 Weeks | 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 |
| Mean Glucose Change at 14 Weeks | 14 weeks | average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks |
Countries
United States
Participant flow
Recruitment details
note study was closed early given covid so enrollement was 23 not 45 as in orginal protocol
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 8 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | DEXCOM G6 RT-CGM | Blinded CGM | Total |
|---|---|---|---|
| Age, Customized Participants were between the ages of 18 and 55 years old | 15 years | 8 years | 23 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 8 |
| other Total, other adverse events | 0 / 15 | 0 / 8 |
| serious Total, serious adverse events | 0 / 15 | 0 / 8 |
Outcome results
Primary
Percent Body Fat Change at 14 Weeks
Percent by Tanita scale
Time frame: 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXCOM G6 RT-CGM | Percent Body Fat Change at 14 Weeks | 1.7 % change over 14 weeks | Standard Deviation 3.5 |
| Blinded CGM | Percent Body Fat Change at 14 Weeks | -1.6 % change over 14 weeks | Standard Deviation 3.2 |
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
Time frame: 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXCOM G6 RT-CGM | Percent Change in BMI From Baseline to 14 Weeks | -0.3 % change over 14 weeks | Standard Deviation 0.5 |
| Blinded CGM | Percent Change in BMI From Baseline to 14 Weeks | -0.2 % change over 14 weeks | Standard Deviation 0.9 |
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
Time frame: 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXCOM G6 RT-CGM | Change in Minutes Walked Per Week at 14 Weeks | 438.8 minutes walked per week | Standard Deviation 535.4 |
| Blinded CGM | Change in Minutes Walked Per Week at 14 Weeks | 232.0 minutes walked per week | Standard Deviation 343.6 |
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
Time frame: 14 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DEXCOM G6 RT-CGM | Food Frequency Change in Score at 14 Weeks | -2.0 score on a scale |
| Blinded CGM | Food Frequency Change in Score at 14 Weeks | 0 score on a scale |
Secondary
MAGE Mean Amplitude of Glycemic Excursion
this is calculation of variance of glucose for CGM
Time frame: 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXCOM G6 RT-CGM | MAGE Mean Amplitude of Glycemic Excursion | 95.1 mg/100ml | Standard Deviation 32.3 |
| Blinded CGM | MAGE Mean Amplitude of Glycemic Excursion | 90.1 mg/100ml | Standard Deviation 85.9 |
p-value: 0.694t-test, 2 sided
Secondary
Mean Glucose Change at 14 Weeks
average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks
Time frame: 14 weeks
Population: CGM average glucose(mg/dL)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXCOM G6 RT-CGM | Mean Glucose Change at 14 Weeks | -0.3 % change over 14 weeks | Standard Deviation 28.9 |
| Blinded CGM | Mean Glucose Change at 14 Weeks | 23.0 % change over 14 weeks | Standard Deviation 61.9 |
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
Time frame: 14 weeks
Population: All participants in the CGM Intervention group. Blinded group did not complete this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEXCOM G6 RT-CGM | Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes | 75.8 score on a scale | Standard Deviation 9.3 |