Status:
COMPLETED
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Stanford University
Klue, Inc.
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03809858
Start Date
May 29 2019
End Date
November 18 2019
Last Update
April 21 2020
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908