Real-time Reminders To Decrease Late or Missed Meal Boluses

Study Overview
=================
Brief Summary
-----------------
This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.

Detailed Description
-----------------
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) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have 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
-----------------
Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

Conditions
-----------------
Type1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Klue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 13 and over On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM Willing to wear a CGM at least 70% of the time while in the study Using an iPhone 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 two weeks Understanding and willingness to follow the protocol and sign informed consent Ability to speak, read and write in the language of the investigators Exclusion Criteria: Pregnant or lactating A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol Current treatment for a seizure disorder Inpatient psychiatric treatment in the past 6 months Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. They may be participating in another trial, if this study is approved by the investigators of the other trial.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory | |
| Experimental: Klue<br>Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software. | Device: Klue<br>* Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of missed meal boluses | A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise. | The two weeks prior to each study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time in range | sensor glucose values between 70-180 mg/dl | data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject | 
| Positive predictive value of a Klue meal alert | Percent of time a meal alert signaled a meal | All data for the 6 weeks on the Klue intervention arm when Klue is active |