Real-time Reminders To Decrease Late or Missed Meal Boluses (Klue)
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|ClinicalTrials.gov Identifier: NCT03970889|
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : September 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type1 Diabetes Mellitus||Device: Klue||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Subjects are randomized so that half will use the Klue App in the first 6 weeks of the study, and half will use the Klue App during the second 6 weeks of the study.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses|
|Actual Study Start Date :||October 12, 2018|
|Actual Primary Completion Date :||March 19, 2020|
|Actual Study Completion Date :||March 30, 2020|
No Intervention: Standard Care
Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory
Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software.
Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.
- Change in the number of missed meal boluses [ Time Frame: The two weeks prior to each study visit ]A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise.
- Change in time in range [ Time Frame: data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject ]sensor glucose values between 70-180 mg/dl
- Positive predictive value of a Klue meal alert [ Time Frame: All data for the 6 weeks on the Klue intervention arm when Klue is active ]Percent of time a meal alert signaled a meal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970889
|United States, California|
|Palo Alto, California, United States, 94305|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|