Diabetes Mellitus, Type 1
Conditions
Keywords
Klue, Meal bolus, Bolus reminder
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.
Interventions
OTHERKlue App
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.
Sponsors
Stanford University
Klue, Inc.
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Subjects will be randomized to the sequence of completion in a 1:1 ratio. All subject will collect data throughout the study with half of them using the Klue App during the first 6 weeks and half using the Klue App during the second 6 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of missed meal boluses | During the two weeks prior to each visit | The change in the number of missed meal boluses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of missed meal boluses as a measure of attenuation to the alerts | 6 weeks | The change in the number of missed meal boluses as a measure of attenuation to the alerts |
| Change in Hemoglobin A1c Levels | 3 months | Change in Hemoglobin A1c Levels |
| Time in range 70-180 mg/dL | 6 weeks | Time in range 70-180 mg/dL as measured by CGM |
| Percent time <70 mg/dL mean glucose | 6 weeks | Percent time \<70 mg/dL mean glucose as measured by CGM |
| Glucose Coefficient of Variation | 6 weeks | Glucose (as measured by CGM) Coefficient of Variation |
| Total daily insulin dose | 6 weeks | Total daily insulin dose |
| Total daily basal insulin | 6 weeks | Total daily basal insulin |
| Number of total bolus injections each day | 6 weeks | Number of total bolus injections each day |
| Accuracy of Klue in detecting meals | 3 months | Accuracy of Klue in detecting meals (true positive and false positive rates) |
| User satisfaction of Klue | 3 months | User satisfaction of Klue |
| 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) |
| 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) |
| Number of meal bolus injections each day | 6 weeks | Number of meal bolus injections each day |
Countries
United States
Outcome results
None listed