Wearable Sensors and Artificial Intelligence for Carbohydrate Counting

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05335889
• Other study ID #: 21-01714
• Status: Completed
• Start date: July 18, 2022
• Est. completion date: September 22, 2023

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• eButton
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)
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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