| Primary Outcome Measures: | |
| 1. |
Change in HbA1c% at 6 months
[ Time Frame: Baseline to 6 months ]
Hemoglobin A1c levels (%) are measured using standard laboratory methods |
| Secondary Outcome Measures: | |
| 1. |
Change in HbA1c% at 12 months
[ Time Frame: Baseline and 12 months ]
Hemoglobin A1c levels (%) are measured using standard laboratory methods |
| 2. |
Percent weight loss at 6 months
[ Time Frame: Baseline and 6 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| 3. |
Percent weight loss at 12 months
[ Time Frame: Baseline and 12 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| 4. |
Change in systolic blood pressure at 6 months
[ Time Frame: Baseline and 6 months ]
Systolic blood pressure is measured using standard clinical methods |
| 5. |
Change in systolic blood pressure at 12 months
[ Time Frame: Baseline and 12 months ]
Systolic blood pressure is measured using standard clinical methods |
| 6. |
Change in diastolic blood pressure at 6 months
[ Time Frame: Baseline and 6 months ]
Diastolic blood pressure is measured using standard clinical methods |
| 7. |
Change in diastolic blood pressure at 12 months
[ Time Frame: Baseline and 12 months ]
Diastolic blood pressure is measured using standard clinical methods |
| 8. |
Change in diabetes distress at 6 months
[ Time Frame: Baseline and 6 months ]
The Diabetes Distress Scale (DDS-17) contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad. |
| 9. |
Change in diabetes distress at 12 months
[ Time Frame: Baseline and 12 months ]
The Diabetes Distress Scale (DDS-17) contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad. |
| 10. |
Change in diabetes treatment satisfaction at 6 months
[ Time Frame: Baseline and 6 months ]
This survey is an 8-item survey that measures satisfaction of treatment plan for diabetes that includes use of medications, diet, and lifestyle change methods. DTSQ is not only used for comparisons between different treatment strategies but also used to assess quality of diabetes care in clinical settings. Each question is scored from zero to six, and the scores are summed, with higher scores indicating higher treatment satisfaction. |
| 11. |
Change in diabetes treatment satisfaction at 12 months
[ Time Frame: Baseline and 12 months ]
This survey is an 8-item survey that measures satisfaction of treatment plan for diabetes that includes use of medications, diet, and lifestyle change methods. DTSQ is not only used for comparisons between different treatment strategies but also used to assess quality of diabetes care in clinical settings. Each question is scored from zero to six, and the scores are summed, with higher scores indicating higher treatment satisfaction. |
| 12. |
Change in quality of life at 6 months
[ Time Frame: Baseline and 6 months ]
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individuals perception of how their weight affects their day-to-day life. There are 31 items rated on a Likert scale 5-Always True to 1-Never True. Items are broken into subscales for physical function, self-esteem, sexual life, public distress, and work. Scale scores are obtained by adding item scores, and the total score is obtained by adding scale scores. Higher scores indicate poorer quality of life. |
| 13. |
Change in quality of life at 12 months
[ Time Frame: Baseline and 12 months ]
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individuals perception of how their weight affects their day-to-day life. There are 31 items rated on a Likert scale 5-Always True to 1-Never True. Items are broken into subscales for physical function, self-esteem, sexual life, public distress, and work. Scale scores are obtained by adding item scores, and the total score is obtained by adding scale scores. Higher scores indicate poorer quality of life. |
| 14. |
Percentage of patients achieving 3% weight loss at 6 months
[ Time Frame: Baseline and 6 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| 15. |
Percentage of patients achieving 3% weight loss at 12 months
[ Time Frame: Baseline and 12 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| 16. |
Percentage of patients achieving 5% weight loss at 6 months
[ Time Frame: Baseline and 6 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| 17. |
Percentage of patients achieving 5% weight loss at 12 months
[ Time Frame: Baseline and 12 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| 18. |
Percentage of patients achieving 10% weight loss at 6 months
[ Time Frame: Baseline and 6 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| 19. |
Percentage of patients achieving 10% weight loss at 12 months
[ Time Frame: Baseline and 12 months ]
Body weight is measured using standard methods with the patient wearing light clothing |
| Other Outcome Measures: | |
| 1. |
Change in Body Mass Index at 6 months
[ Time Frame: Baseline and 6 months ]
Height and weight are measured using standard laboratory methods |
| 2. |
Change in Body Mass Index at 12 months
[ Time Frame: Baseline and 12 months ]
Height and weight are measured using standard laboratory methods |
| 3. |
Change in waist circumference at 6 months
[ Time Frame: Baseline and 6 months ]
Waist circumference is measured using standard methods with an inelastic tape |
| 4. |
Change in waist circumference at 12 months
[ Time Frame: Baseline and 12 months ]
Waist circumference is measured using standard methods with an inelastic tape |
| 5. |
Change in physical activity at 6 months
[ Time Frame: Baseline and 6 months ]
Physical activity is measured with the Global Physical Activity Questionnaire, a valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions. |
| 6. |
Change in physical activity at 12 months
[ Time Frame: Baseline and 12 months ]
Physical activity is measured with the Global Physical Activity Questionnaire, a valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions. |
| 7. |
Change in dietary intake at 6 months
[ Time Frame: Baseline and 6 months ]
Dietary intake is assessed using DietID (www.dietid.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient data and Healthy Eating Index 2015 score. |
| 8. |
Change in dietary intake at 12 months
[ Time Frame: Baseline and 12 months ]
Dietary intake is assessed using DietID (www.dietid.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient data and Healthy Eating Index 2015 score. |
| 9. |
Change in diabetes medications at 6 months
[ Time Frame: Baseline and 6 months ]
The number of diabetes medications is summed at each time point |
| 10. |
Change in diabetes medications at 12 months
[ Time Frame: Baseline and 12 months ]
The number of diabetes medications is summed at each time point |
| 11. |
Change in perceived stress at 6 months
[ Time Frame: Baseline and 6 months ]
Perceived stress is measured with the perceived stress scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress. |
| 12. |
Change in perceived stress at 12 months
[ Time Frame: Baseline and 12 months ]
Perceived stress is measured with the perceived stress scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress. |
| 13. |
Change in well-being at 6 months
[ Time Frame: Baseline and 6 months ]
Well-being is measured using the World Health Organization-5, a self-reported measure of current mental wellbeing. The questionnaire consists of five statements, which respondents rate according to the scale (in relation to the past two weeks): All of the time = 5, Most of the time = 4, More than half of the time = 3, Less than half of the time = 2, Some of the time = 1, At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. |
| 14. |
Change in well-being at 12 months
[ Time Frame: Baseline and 12 months ]
Well-being is measured using the World Health Organization-5, a self-reported measure of current mental wellbeing. The questionnaire consists of five statements, which respondents rate according to the scale (in relation to the past two weeks): All of the time = 5, Most of the time = 4, More than half of the time = 3, Less than half of the time = 2, Some of the time = 1, At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. |
| 15. |
Change in habit strength at 6 months
[ Time Frame: Baseline and 6 months ]
Habit strength is measured with the Self-Report Behavioral Automaticity Index, a reliable measure with convergent and predictive validity for capturing habitual patterns of behavior. Each behavior of interest is assessed by 4 items rated on a Likert scale 1-strongly disagree to 7-strongly agree. |
| 16. |
Change in habit strength at 12 months
[ Time Frame: Baseline and 12 months ]
Habit strength is measured with the Self-Report Behavioral Automaticity Index, a reliable measure with convergent and predictive validity for capturing habitual patterns of behavior. Each behavior of interest is assessed by 4 items rated on a Likert scale 1-strongly disagree to 7-strongly agree. |
| 17. |
Change in food cravings at 6 months
[ Time Frame: Baseline and 6 months ]
Food cravings are assessed using the Food Cravings Inventory II, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, & fruits and vegetables. The inventory is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, & Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. Fruit/Vegetable=Average of items 5,12,18,21,29. Total=Average of all 33 items. |
| 18. |
Change in food cravings at 12 months
[ Time Frame: Baseline and 12 months ]
Food cravings are assessed using the Food Cravings Inventory II, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, & fruits and vegetables. The inventory is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, & Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. Fruit/Vegetable=Average of items 5,12,18,21,29. Total=Average of all 33 items. |
| 19. |
Change in emotional eating at 6 months
[ Time Frame: Baseline and 6 months ]
Emotional eating is measured with the Palatable Eating Motives-Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always. |
| 20. |
Change in emotional eating at 12 months
[ Time Frame: Baseline and 12 months ]
Emotional eating is measured with the Palatable Eating Motives-Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always. |
| 21. |
Change in hunger at 6 months
[ Time Frame: Baseline and 6 months ]
Hunger is measured with the Hunger Visual Analog Scale that asks participants to rate how hungry they felt over the past week on an 100 mm horizontal line with endpoints of "Not at all hungry" to "Extremely hungry." Visual analog scales are scored by measuring in mm where the participant places their tick mark on the horizontal line. |
| 22. |
Change in hunger at 12 months
[ Time Frame: Baseline and 12 months ]
Hunger is measured with the Hunger Visual Analog Scale that asks participants to rate how hungry they felt over the past week on an 100 mm horizontal line with endpoints of "Not at all hungry" to "Extremely hungry." Visual analog scales are scored by measuring in mm where the participant places their tick mark on the horizontal line. |
| 23. |
Change in self compassion at 6 months
[ Time Frame: Baseline and 6 months ]
Self compassion is measured with the Self-Compassion Scales, which contains 26 individual items and 6 subscales: Self-Kindness (5, 12, 19, 23, 26), Self-Judgment (1, 8, 11, 16, 21), Common Humanity (3, 7, 10, 15), Isolation (4, 13, 18, 25), Mindfulness (9, 14, 17, 22), and Over-identified (2, 6, 20, 24). Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, reverse score the negative subscale items - self-judgment, isolation, and over-identification - then compute a total mean. |
| 24. |
Change in self compassion at 12 months
[ Time Frame: Baseline and 12 months ]
Self compassion is measured with the Self-Compassion Scales, which contains 26 individual items and 6 subscales: Self-Kindness (5, 12, 19, 23, 26), Self-Judgment (1, 8, 11, 16, 21), Common Humanity (3, 7, 10, 15), Isolation (4, 13, 18, 25), Mindfulness (9, 14, 17, 22), and Over-identified (2, 6, 20, 24). Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, reverse score the negative subscale items - self-judgment, isolation, and over-identification - then compute a total mean. |
| 25. |
Change in weight bias at 6 months
[ Time Frame: Baseline and 6 months ]
The Weight Bias Internalization Scale-2F has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average. |
| 26. |
Change in weight bias at 12 months
[ Time Frame: Baseline and 12 months ]
The Weight Bias Internalization Scale-2F has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average. |
| 27. |
Change in dietary restraint/disinhibition at 6 months
[ Time Frame: Baseline and 6 months ]
The Three Factor Eating Questionnaire - Restraint and Disinhibition subscales measure cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate higher levels of restraint or disinhibition. |
| 28. |
Change in dietary restraint/disinhibition at 12 months
[ Time Frame: Baseline and 12 months ]
The Three Factor Eating Questionnaire - Restraint and Disinhibition subscales measure cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate higher levels of restraint or disinhibition. |
| 29. |
Change in body appreciation at 6 months
[ Time Frame: Baseline and 6 months ]
The Body Appreciation Scale-2 measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always. |
| 30. |
Change in body appreciation at 12 months
[ Time Frame: Baseline and 12 months ]
The Body Appreciation Scale-2 measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always. |
| 31. |
Change in proportion of patients achieving HbA1c% <=6.5% at 6 months
[ Time Frame: Baseline and 6 months ]
Hemoglobin A1c levels (%) are measured using standard laboratory methods |
| 32. |
Change in proportion of patients achieving HbA1c% <=6.5% at 12 months
[ Time Frame: Baseline and 12 months ]
Hemoglobin A1c levels (%) are measured using standard laboratory methods |
| 33. |
Change in satisfaction and engagement with the intervention at 6 months
[ Time Frame: Baseline and 6 months ]
An Intervention Satisfaction Survey is used to capture the participant experience in the program. This survey will be administered to the intervention group only at 6 months and 12 months. The survey consists of 49 items with responses on a 5-point Likert scale. |
| 34. |
Change in satisfaction and engagement with the intervention at 12 months
[ Time Frame: Baseline and 12 months ]
An Intervention Satisfaction Survey is used to capture the participant experience in the program. This survey will be administered to the intervention group only at 6 months and 12 months. The survey consists of 49 items with responses on a 5-point Likert scale. |
| 35. |
Change in eating disorders at 6 months
[ Time Frame: Baseline and 6 months ]
The Eating Disorders Examination Questionnaire is a 28-item questionnaire with 4 subscales. The questionnaire provides a continuous score that indicates the severity of psychopathology of eating disorders. The subscales are Restraint (1, 2, 3, 4, 5), Eating Concern (7, 9, 19, 21, 20), Shape Concern (6, 8, 23, 10, 26, 27, 28, 11), and Weight Concern (22, 24, 8, 25, 12). To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscales. If ratings are only available on some items, a score may nevertheless be obtained by dividing the resulting total by the number of rated items so long as more than half the items have been rated. To obtain an overall or "global" score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e. four). Subscales scores are reported as means and standard deviations. |
| 36. |
Change in eating disorders at 12 months
[ Time Frame: Baseline and 12 months ]
The Eating Disorders Examination Questionnaire is a 28-item questionnaire with 4 subscales. The questionnaire provides a continuous score that indicates the severity of psychopathology of eating disorders. The subscales are Restraint (1, 2, 3, 4, 5), Eating Concern (7, 9, 19, 21, 20), Shape Concern (6, 8, 23, 10, 26, 27, 28, 11), and Weight Concern (22, 24, 8, 25, 12). To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscales. If ratings are only available on some items, a score may nevertheless be obtained by dividing the resulting total by the number of rated items so long as more than half the items have been rated. To obtain an overall or "global" score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e. four). Subscales scores are reported as means and standard deviations. |
| 37. |
Cost-effectiveness of the intervention at 6 months
[ Time Frame: Baseline and 6 months ]
Cost-effectiveness will be measured by comparing the cost of delivering the intervention relative to the observed reductions in HbA1c. |
| 38. |
Cost-effectiveness of the intervention at 12 months
[ Time Frame: Baseline and 12 months ]
Cost-effectiveness will be measured by comparing the cost of delivering the intervention relative to the observed reductions in HbA1c. |
| 39. |
Change in time in range between 70 and 180 mg/dl of glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 40. |
Change in time in range between 70 and 180 mg/dl of glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 41. |
Change in time in range between 70 and 140 mg/dl of glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 42. |
Change in time in range between 70 and 140 mg/dl of glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 43. |
Change in time in range between 140 and 180 mg/dl of glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 44. |
Change in time in range between 140 and 180 mg/dl of glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 45. |
Change in time spent above 180 mg/dl of glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 46. |
Change in time spent above 180 mg/dl of glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 47. |
Change in time spent above 250 mg/dl of glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 48. |
Change in time spent above 250 mg/dl of glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 49. |
Change in time spent below 70 mg/dl of glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 50. |
Change in time spent below 70 mg/dl of glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 51. |
Change in time spent below 54 mg/dl of glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 52. |
Change in time spent below 54 mg/dl of glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 53. |
Change in average glucose at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 54. |
Change in average glucose at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 55. |
Change in glucose variability (standard deviation) at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 56. |
Change in glucose variability (standard deviation) at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 57. |
Change in glucose variability (coefficient of variation) at 6 months
[ Time Frame: Baseline and 6 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
| 58. |
Change in glucose variability (coefficient of variation) at 12 months
[ Time Frame: Baseline and 12 months ]
Glucose is measured by continuous glucose monitoring for 2 weeks at each time point |
