Wearable Sensors and Artificial Intelligence for Carbohydrate Counting

Study Overview
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Brief Summary
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This is a one-group pilot study where Chinese immigrants who are English speaking with T2D from NYU Langone Health and NYU Brooklyn Family Health Center (Sunset Park) will be recruited.

Detailed Description
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To evaluate the estimation accuracy using eButton, researchers will collect carbohydrate data via weighing food by registered dietitian nutritionist (RDN) (gold standard) (2 days/week at research labs) and food diaries by participants (2 days/week at research labs and 3 days/ week at participant home). Then, the estimated carb grams will be compared head to head among each other. Assessment will be at 0 and 2 weeks, including surveys and qualitative audio interview.

Official Title
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Feasibility of Using Wearable Sensors and Artificial Intelligence for Carbohydrate Counting in Chinese Americans With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: eButton
* Device: Continuous Glucose Monitoring (CGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old Diagnosed with T2D at least one year prior Self-identified as first- or second-generation Chinese immigrants Feel comfortable communicating in English, the reason is that the questionnaires/surveys are validated in English Have a computer and internet connection Exclusion Criteria: Plan frequent travel or vacations or plan to relocate in the next five weeks Have serious diabetes-related complications, physical illness, or mental illness (e.g., schizophrenia, bipolar disorder, or substance abuse) that would preclude participation Have severe cognitive impairments (e.g., dementia, intellectual disability)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 Diabetes group<br>Participants with Type 2 Diabetes will wear eButton and Continuous Glucose Monitoring (CGM) for 2 weeks and complete food diaries to record carb grams. | Device: eButton<br>* The eButton is a wearable camera that takes pictures every 6 seconds of whatever is in front of participants. The recorded data are processed by algorithms to determine food names, volumes, and nutrient value of the consumed food (e.g., grams of carbohydrates). The eButton is a wearable device containing a multicore microprocessor, a rechargeable battery capable of 10-15 hours of continuous operation (upon a flexible choice of battery capacity), a miniSD card for data storage.<br>Device: Continuous Glucose Monitoring (CGM)<br>* The use of this device provides ambulatory glucose profiles, giving graphic and quantitative information on 24-hour glucose patterns. It does not require finger-prick testing for calibration. The system consists of a reader and a sensor (35 mm x 5 mm). The sensor is applied to the back of a person's arm. The sensor automatically measures interstitial glucose at 15-minute intervals during daily activities like work, sleep, eating, and exercise. It is able to store blocks of glucose data for 14 days.<br>* Other names: FreeStyle Libre Pro model;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Carbohydrate Counting using eButton (absolute error) | The estimated carb grams using the eButton, gold standard, and participants' food diaries will be compared head to head among each other. The absolute error will be computed: the difference between the estimated value and the gold standard (estimated - gold standard). Bland-Altman plots will be used to examine the level of agreement between eButton and gold standard measurements. | Day 14 | 
| Accuracy of Carbohydrate Counting using eButton (relative error) | The estimated carb grams using the eButton, gold standard, and participants' food diaries will be compared head to head among each other. The relative error will be computed: the percentage difference between the estimated value relative to the gold standard. Relative errors will be reported using boxplots to allow visual comparison of the distribution and variability in errors across all methods. Bland-Altman plots will be used to examine the level of agreement between eButton and gold standard measurements. | Day 14 | 
| Proportion of participants who are fully compliant with eButton use | Proportion of participants who are fully compliant with eButton use and proportion of meals evaluated using eButton, with 95% confidence intervals will be qualitatively reported. Perceived usefulness and perceived ease of use will be summarized as mean and standard deviation. | Day 14 |