Wearable Sensors and Artificial Intelligence for Carbohydrate Counting

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: eButton; Device: Continuous Glucose Monitoring (CGM)

• Registration Number: NCT05335889
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-20
• Study Start: 2022-07-18
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes group	eButton	Participants with Type 2 Diabetes will wear eButton and Continuous Glucose Monitoring (CGM) for 2 weeks and complete food diaries to record carb grams.
Type 2 Diabetes group	Continuous Glucose Monitoring (CGM)	Participants with Type 2 Diabetes will wear eButton and Continuous Glucose Monitoring (CGM) for 2 weeks and complete food diaries to record carb grams.

Primary Outcome Measures

Name	Time	Method
Accuracy of Carbohydrate Counting using eButton (absolute error)	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.
Accuracy of Carbohydrate Counting using eButton (relative error)	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.
Proportion of participants who are fully compliant with eButton use	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States