Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of missed meal boluses
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Klue App Use then Usual Care
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.
Intervention: Klue App (Other)
Usual Care then Klue App Use
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.
Intervention: Klue App (Other)
Outcomes
Primary Outcomes
Number of missed meal boluses
Time Frame: During the two weeks prior to each visit
The change in the number of missed meal boluses
Secondary Outcomes
- Time in range 70-180 mg/dL(12 weeks)
- Percent time <70 mg/dL mean glucose(12 weeks)
- User satisfaction of Klue(3 months)
- Glucose Coefficient of Variation(12 weeks)
- Total daily basal insulin(12 weeks)
- Change in Hemoglobin A1c Levels(3 months)
- Total daily insulin dose(12 weeks)
- Diabetes Distress Scale (DDS) Scores(3 months)
- Accuracy of Klue in detecting meals(3 months)
- Number of missed meal boluses as a measure of attenuation to the alerts(12 weeks)
- Number of meal bolus injections each day(12 weeks)
- Number of total bolus injections each day(12 weeks)
- Diabetes-Specific Attitudes about Technology (DSAT) Scores(3 months)
- Number of missed meal boluses as a measure of attenuation to the alerts(6 weeks)
- Time in range 70-180 mg/dL(6 weeks)
- Percent time <70 mg/dL mean glucose(6 weeks)
- Glucose Coefficient of Variation(6 weeks)
- Total daily insulin dose(6 weeks)
- Number of meal bolus injections each day(6 weeks)
- Number of total bolus injections each day(6 weeks)
- Total daily basal insulin(6 weeks)
Investigators
Marc Breton
Associate Professor
University of Virginia