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Completed

NCT Number: NCT05335889

Wearable Sensors and Artificial Intelligence for Carbohydrate Counting

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

eButton

Device

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.

Continuous glucose monitoring (CGM)

Device

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.

Other names: FreeStyle Libre Pro model

Primary outcomes

  1. Accuracy of Carbohydrate Counting using eButton (absolute error)

    Time frame: Day 14

    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.

  2. Accuracy of Carbohydrate Counting using eButton (relative error)

    Time frame: Day 14

    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.

  3. Proportion of participants who are fully compliant with eButton use

    Time frame: Day 14

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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