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| ID | Type | Description | Link |
|---|---|---|---|
| 2207 | Other Grant/Funding Number | Helmsley Charitable Trust |
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| Name | Class |
|---|---|
| Leona M. & Harry B. Helmsley Charitable Trust | UNKNOWN |
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The purpose of this study is to learn more about a smartphone application (app) called DailyDose, an investigational decision support tool that may help in managing your diabetes. DailyDose tracks your continuous glucose monitoring (CGM) data, insulin use, and exercise, and uses this information to provide personalized recommendations for insulin dosing and carbohydrate intake during exercise or low blood sugar events. We want to find out if DailyDose can help lower blood sugar levels as measured by the hemoglobin A1c (HbA1c) test.
Participants will be on study for 38 weeks (2-week run-in period and 36 weeks of intervention/control). Participants will begin the study with a training visit on the Dexcom G6 CGM system, the insulin dose capture system, and the Data-logging Mode of DailyDose. Participants will be provided with Humalog and Basaglar Tempo pens for use with the insulin dose capture system. Participants will also receive an iPhone and Apple smart watch for acquiring sleep metrics and exercise data. Participants will use these devices during the next 14 days at home (2-week run-in). At the end of the run-in, participants will be randomized to the intervention or control group. The intervention group will be trained at Visit 3 on using the DailyDose system. Participants will then use the DailyDose system for 12 weeks. Sensor glucose, exercise, insulin and meal data will be collected during the DailyDose portion of the study in order to produce recommendations for insulin dosing. Participants will wear the Dexcom G6 for the entire study. Insulin data will be collected using the insulin dose capture system (Tempo pens and Tempo button). Participants will be instructed to use the bolus calculator within the DailyDose app. Participants will be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period. After 12 weeks, time in range (70-180 mg/dL, TIR) and time in hypoglycemia (<70 mg/dL) will be assessed from the prior 4 weeks based on the Dexcom G6. Participants that have TIR ≥ 60% and time in hypoglycemia <4% will continue with use of DailyDose. Those that have TIR < 60% and/or time in hypoglycemia ≥ 4% will receive DSMES and, if recommended, behavioral health based on the T1-Diabetes Distress Assessment System (T1-DDAS) for the next 12 weeks. Additionally, if the DSMES provider feels the participant would benefit from behavioral health intervention, they can refer the participant for this even if T1-DDAS scores do not meet the cut off. All participants will then be followed for a final 12-week period using DailyDose alone to assess sustainability of any improvements in glycemic outcomes. Participants in the control group will use the Dexcom G6 CGM, the insulin dose capture system (Tempo pens and Tempo button), and the Data-logging Mode of DailyDose for the entire study. They will also be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | AB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated |
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| Control Group | No Intervention | Usual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DailyDose | Device | Our team has developed a smartphone-based application, DailyDose Decision Support Tool (DailyDose), that combines continuous glucose monitoring data and insulin data to provide decision support for people living with T1D taking MDI. DailyDose is an iPhone application that is designed to support this population by 1) allowing for bolus calculation based on inputs including carbohydrate intake, CGM value and trend, and exercise information, 2) providing recommendations for carbohydrate intake based on exercise type, intensity, and duration, and 3) providing weekly recommendations for adjustments in insulin doses at specific times of day, including basal insulin dose, carbohydrate ratios or fixed mealtime doses, and correction factors . |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin A1c (HbA1c) from baseline to 24 weeks after randomization | Hemoglobin A1c will be processed by a central lab. Lower values generally indicate better glucose control. | Enrollment and 24 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin A1c (HbA1c) from baseline to 36 weeks after randomization | Hemoglobin A1c will be processed by a central lab. | Enrollment and 36 weeks after randomization. |
| Change in percent of time in range (70-180 mg/dL) from baseline to 24 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean number of low glucose events / week from baseline to 24 weeks after randomization | A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 24 after randomization compared with baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leah Wilson, MD | Contact | 503-494-3273 | wilsolea@ohsu.edu | |
| Samrita Thapa | Contact | 503-494-8421 | thapasa@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leah Wilson, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States |
IPD cannot be shared due to concerns about participant privacy and confidentiality.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. |
| Week 24 after randomization compared with baseline |
| Change in percent of time in range (70-180 mg/dL) from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 36 after randomization compared with baseline |
| Change in percent of time in tight range (70-140 mg/dL) from baseline to 24 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 24 after randomization compared with baseline |
| Change in percent of time in tight range (70-140 mg/dL) from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 36 after randomization compared with baseline |
| Change in percent of time in low glucose range (<70 mg/dL) from baseline to 24 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 24 after randomization compared with baseline |
| Change in percent of time in low glucose range (<70 mg/dL) from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 36 after randomization compared with baseline |
| Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 24 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 24 after randomization compared with baseline |
| Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 36 after randomization compared with baseline |
| Change in percent of time in high glucose range (>180 mg/dL) from baseline to 24 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 24 after randomization compared with baseline |
| Change in percent of time in high glucose range (>180 mg/dL) from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 36 after randomization compared with baseline |
| Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 24 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 24 after randomization compared with baseline |
| Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 36 after randomization compared with baseline |
| Change in mean blood glucose from baseline to 24 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point. | Week 24 after randomization compared with baseline |
| Change in mean blood glucose from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point. | Week 36 after randomization compared with baseline |
| Change in coefficient of variation of blood glucose from baseline to 24 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean * 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point. | Week 24 after randomization compared with baseline |
| Change in coefficient of variation of blood glucose from baseline to 36 weeks after randomization | Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean * 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point. | Week 36 after randomization compared with baseline |
| Change in Low Blood Glucose Index (LBGI) from baseline to 24 weeks after randomization | The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 * f(BG)^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL. | Week 24 after randomization compared with baseline |
| Change in Low Blood Glucose Index (LBGI) from baseline to 36 weeks after randomization | The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 * f(BG)^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL. | Week 36 after randomization compared with baseline |
| Change in High Blood Glucose Index (HBGI) from baseline to 24 weeks after randomization | The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 * f(BG)^2 if f(BG) > 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL. | Week 24 after randomization compared with baseline |
| Change in High Blood Glucose Index (HBGI) from baseline to 36 weeks after randomization | The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 * f(BG)^2 if f(BG) > 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL. | Week 36 after randomization compared with baseline |
| Change in T1-DDAS Core Score from baseline to 24 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes. | Week 24 after randomization compared with baseline |
| Change in T1-DDAS Core Score from baseline to 36 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes. | Week 36 after randomization compared with baseline |
| Change in T1-DDAS Management Difficulties Source Score from baseline to 24 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes. | Week 24 after randomization compared with baseline |
| Change in T1-DDAS Management Difficulties Source Score from baseline to 36 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes. | Week 36 after randomization compared with baseline |
| Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 24 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia. | Week 24 after randomization compared with baseline |
| Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 36 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia. | Week 36 after randomization compared with baseline |
| Change in T1-DDAS Technology Challenges Source Score from baseline to 24 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes. | Week 24 after randomization compared with baseline |
| Change in T1-DDAS Technology Challenges Source Score from baseline to 36 weeks after randomization | The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes. | Week 36 after randomization compared with baseline |
| Change in mean number of low glucose events / week from baseline to 36 weeks after randomization | A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point. | Week 36 after randomization compared with baseline |
| Change in total daily dose of insulin (units) from baseline to 24 weeks | Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point. | Week 24 after randomization compared with baseline |
| Change in total daily dose of insulin (units) from baseline to 36 weeks | Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point. | Week 36 after randomization compared with baseline |
| Change in total daily dose of insulin per kilogram (units/kg) from baseline to 36 weeks | Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point. | Week 36 after randomization compared with baseline |
| Change in body weight measured at 36 weeks after randomization | Maintaining or losing weight, rather than gaining, would be considered a positive outcome. | Week 36 after randomization compared with baseline |
| University of Southern California | Los Angeles | California | 90022 | United States |
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
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| Joslin Diabetes Center, Harvard School of Medicine | Boston | Massachusetts | 02215 | United States |
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| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
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| Oregon Health & Science University , Portland | Portland | Oregon | 97239 | United States |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |