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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
University of Virginia
Charlottesville, Virginia, United States
Number of missed meal boluses
The change in the number of missed meal boluses
Time frame: During the two weeks prior to each visit
Number of missed meal boluses as a measure of attenuation to the alerts
The change in the number of missed meal boluses as a measure of attenuation to the alerts
Time frame: 6 weeks
Number of missed meal boluses as a measure of attenuation to the alerts
The change in the number of missed meal boluses as a measure of attenuation to the alerts
Time frame: 12 weeks
Change in Hemoglobin A1c Levels
Change in Hemoglobin A1c Levels
Time frame: 3 months
Time in range 70-180 mg/dL
Time in range 70-180 mg/dL as measured by CGM
Time frame: 6 weeks
Time in range 70-180 mg/dL
Time in range 70-180 mg/dL as measured by CGM
Time frame: 12 weeks
Percent time <70 mg/dL mean glucose
Percent time \<70 mg/dL mean glucose as measured by CGM
Time frame: 6 weeks
Percent time <70 mg/dL mean glucose
Percent time \<70 mg/dL mean glucose as measured by CGM
Time frame: 12 weeks
Glucose Coefficient of Variation
Glucose (as measured by CGM) Coefficient of Variation
Time frame: 6 weeks
Glucose Coefficient of Variation
Glucose (as measured by CGM) Coefficient of Variation
Time frame: 12 weeks
Total daily insulin dose
Total daily insulin dose
Time frame: 6 weeks
Total daily insulin dose
Total daily insulin dose
Time frame: 12 weeks
Number of meal bolus injections each day
Number of meal bolus injections each day
Time frame: 6 weeks
Number of meal bolus injections each day
Number of meal bolus injections each day
Time frame: 12 weeks
Number of total bolus injections each day
Number of total bolus injections each day
Time frame: 6 weeks
Number of total bolus injections each day
Number of total bolus injections each day
Time frame: 12 weeks
Total daily basal insulin
Total daily basal insulin
Time frame: 6 weeks
Total daily basal insulin
Total daily basal insulin
Time frame: 12 weeks
Accuracy of Klue in detecting meals
Accuracy of Klue in detecting meals (true positive and false positive rates)
Time frame: 3 months
User satisfaction of Klue
User satisfaction of Klue
Time frame: 3 months
Diabetes-Specific Attitudes about Technology (DSAT) Scores
DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)
Time frame: 3 months
Diabetes Distress Scale (DDS) Scores
DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)
Time frame: 3 months
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