Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Other: Klue App
- Registration Number
- NCT03809858
- Lead Sponsor
- University of Virginia
- Brief Summary
This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Age 18 and over
- Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
- Willing to wear a CGM at least 70% of the time while in the study
- Willing to wear an Apple watch on their dominant hand while awake
- Missing or late in giving at least four food boluses in the previous 2 weeks
- Understanding and willingness to follow the protocol and sign informed consent
- Pregnant or lactating women
- A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
Subject may participate in another trial if it is approved by the investigators of both trials.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual Care then Klue App Use Klue App Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product. Klue App Use then Usual Care Klue App Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product.
- Primary Outcome Measures
Name Time Method Number of missed meal boluses During the two weeks prior to each visit The change in the number of missed meal boluses
- Secondary Outcome Measures
Name Time Method Change in Hemoglobin A1c Levels 3 months Change in Hemoglobin A1c Levels
Total daily insulin dose 12 weeks Total daily insulin dose
Diabetes Distress Scale (DDS) Scores 3 months DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)
Accuracy of Klue in detecting meals 3 months Accuracy of Klue in detecting meals (true positive and false positive rates)
Number of missed meal boluses as a measure of attenuation to the alerts 12 weeks The change in the number of missed meal boluses as a measure of attenuation to the alerts
Number of meal bolus injections each day 12 weeks Number of meal bolus injections each day
Number of total bolus injections each day 12 weeks Number of total bolus injections each day
Diabetes-Specific Attitudes about Technology (DSAT) Scores 3 months DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)
Time in range 70-180 mg/dL 12 weeks Time in range 70-180 mg/dL as measured by CGM
Percent time <70 mg/dL mean glucose 12 weeks Percent time \<70 mg/dL mean glucose as measured by CGM
User satisfaction of Klue 3 months User satisfaction of Klue
Glucose Coefficient of Variation 12 weeks Glucose (as measured by CGM) Coefficient of Variation
Total daily basal insulin 12 weeks Total daily basal insulin
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States