An interventional study of DailyDose Decision Support in Type 1 Diabetes, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia which can lead to severe acute and chronic complications. The burden and complexity of managing T1D results in the majority of people not reaching adequate glycemic control. Our team has developed a smartphone based application, DailyDose, that combines continuous glucose monitoring data and insulin data to provide decision support for subjects with type 1 diabetes taking multiple daily injections (MDI). DailyDose provides on-demand, real-time dosing recommendations for insulin doses prior to meals and to correct hyperglycemia. DailyDose analyzes glucose patterns and provides weekly recommendations to the patient on insulin settings including carbohydrate ratios and correction factors. As needed, DailyDose will make weekly recommendations to change basal insulin. For subject safety, study investigators will set constraints on settings for short and long acting insulin during the onboarding process. DailyDose will not be able to recommend insulin dose changes above or below the set safety thresholds. DailyDose also provides recommendations on carbohydrate intake for exercise and includes hypoglycemia and hyperglycemia alarms.
Subjects will be on study for 10 weeks. Subjects will begin the study with a training visit on the Dexcom G6 CGM system and the InPen and Clipsulin smart insulin pens. Subjects will use these devices for the next 14 days at home. Subjects will return to OHSU at the end of the 14 days for a training on using the DailyDose system. Subjects will then return home to use the DailyDose system for 8 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. Subjects will receive up to 4 recommendations every 7 days. Subjects will also receive recommendations for exercise based on the PEAK exercise guidelines.
Subjects will wear the Dexcom G6 and an Apple Watch physical activity monitor for the entire study. Insulin data will be collected using the InPen for aspart insulin and Clipsulin for the long acting insulin. Subjects will complete a 30 minute aerobic exercise video at home once per week. Subjects will also be asked to complete two additional exercise sessions on their own at home, one aerobic session and the other whatever type of exercise they would normally do (aerobic, resistance etc.). Subjects will use the bolus calculator within the DailyDose app. Subjects will be instructed to test capillary blood glucose (CBG) after exercise, for symptoms of hypoglycemia or hypoglycemia alerts and again 15 minutes after rescue carbohydrate treatment until CBG >70 mg/dl.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
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Exclusion Criteria:
Subjects will use DailyDose decision support for 8 weeks at home.
Device: DailyDose Decision Support
DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl
Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Time frame: Weeks 1-2 and 9-10
Mean Change in Sensed Glucose
Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Time frame: Weeks 1-2 and 9-10
Mean Change in the Percent of Time With Sensed Glucose <70 mg/dl
Mean change in the percent of time with sensed glucose \< 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Time frame: Weeks 1-2 and 9-10
Mean Change in the Percent of Time With Sensed Glucose <54 mg/dl
Mean change in the percent of time with sensed glucose \< 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Time frame: Weeks 1-2 and 9-10
Mean Change in the Percent of Time With Sensed Glucose >180 mg/dl
Mean change in the percent of time with sensed glucose \>180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Time frame: Weeks 1-2 and 9-10
Mean Change in the Percent of Time With Sensed Glucose >250 mg/dl
Mean change in the percent of time with sensed glucose \>250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Time frame: Weeks 1-2 and 9-10
Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data.
Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
Time frame: Weeks 1-2 and 9-10
| Milestone | DailyDose Decision Support |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
| Milestone | DailyDose Decision Support |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
| Milestone | DailyDose Decision Support |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
| Milestone | DailyDose Decision Support |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | DailyDose Decision Support |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
| percentage of time | DailyDose Decision Support |
|---|---|
| Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl | -3.8 ± 15.8 |
Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
| mg/dL | DailyDose Decision Support |
|---|---|
| Mean Change in Sensed Glucose | 11 ± 28 |
Mean change in the percent of time with sensed glucose \< 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
| percentage of time | DailyDose Decision Support |
|---|---|
| Mean Change in the Percent of Time With Sensed Glucose <70 mg/dl | -0.3 ± 1.0 |
Mean change in the percent of time with sensed glucose \< 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
| percentage of time | DailyDose Decision Support |
|---|---|
| Mean Change in the Percent of Time With Sensed Glucose <54 mg/dl | 0.0006 ± 0.472 |
Mean change in the percent of time with sensed glucose \>180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
| percentage of time | DailyDose Decision Support |
|---|---|
| Mean Change in the Percent of Time With Sensed Glucose >180 mg/dl | 4.1 ± 15.9 |
Mean change in the percent of time with sensed glucose \>250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
| percentage of time | DailyDose Decision Support |
|---|---|
| Mean Change in the Percent of Time With Sensed Glucose >250 mg/dl | 5.4 ± 12.5 |
Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
| percent of CV | DailyDose Decision Support |
|---|---|
| Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data. | -0.3 |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DailyDose Decision Support | 0/25 (0%) | 0/25 (0%) | 2/25 (8%) |
| Event | DailyDose Decision Support |
|---|---|
| upper respiratory infectionInfections and infestations | 2/25 |
| urinary tract infectionInfections and infestations | 1/25 |
| vaginal infectionInfections and infestations | 1/25 |
| strep throatInfections and infestations | 1/25 |
| Age, Categorical(Participants) | DailyDose Decision Support |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 0 |
| Age, Continuous(years) | DailyDose Decision Support |
|---|---|
| Mean | 35.8 ± 9.8 |
| Sex: Female, Male(Participants) | DailyDose Decision Support |
|---|---|
| Female | 14 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | DailyDose Decision Support |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | DailyDose Decision Support |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | DailyDose Decision Support |
|---|---|
| United States | 25 |
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Oregon Health and Science University