Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: Klue App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Klue App Use then Usual Care<br>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. | Other: Klue App<br>* 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.<br>|
| Experimental: Usual Care then Klue App Use<br>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. | Other: Klue App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of missed meal boluses | The change in the number of missed meal boluses | During the two weeks prior to each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 weeks | 
| Change in Hemoglobin A1c Levels | Change in Hemoglobin A1c Levels | 3 months | 
| Time in range 70-180 mg/dL | Time in range 70-180 mg/dL as measured by CGM | 6 weeks | 
| Time in range 70-180 mg/dL | Time in range 70-180 mg/dL as measured by CGM | 12 weeks | 
| Percent time <70 mg/dL mean glucose | Percent time <70 mg/dL mean glucose as measured by CGM | 6 weeks | 
| Percent time <70 mg/dL mean glucose | Percent time <70 mg/dL mean glucose as measured by CGM | 12 weeks | 
| Glucose Coefficient of Variation | Glucose (as measured by CGM) Coefficient of Variation | 6 weeks | 
| Glucose Coefficient of Variation | Glucose (as measured by CGM) Coefficient of Variation | 12 weeks | 
| Total daily insulin dose | Total daily insulin dose | 6 weeks | 
| Total daily insulin dose | Total daily insulin dose | 12 weeks | 
| Number of meal bolus injections each day | Number of meal bolus injections each day | 6 weeks | 
| Number of meal bolus injections each day | Number of meal bolus injections each day | 12 weeks | 
| Number of total bolus injections each day | Number of total bolus injections each day | 6 weeks | 
| Number of total bolus injections each day | Number of total bolus injections each day | 12 weeks | 
| Total daily basal insulin | Total daily basal insulin | 6 weeks | 
| Total daily basal insulin | Total daily basal insulin | 12 weeks | 
| Accuracy of Klue in detecting meals | Accuracy of Klue in detecting meals (true positive and false positive rates) | 3 months | 
| User satisfaction of Klue | User satisfaction of Klue | 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) | 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) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Klue, Meal bolus, Bolus reminder