Type 2 DiabetesNCT05335889
Wearable Sensors and Artificial Intelligence for Carbohydrate Counting
An observational study of Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- eButton and Continuous Glucose Monitoring (CGM)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 22 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Americans participants are targeted to test eButton accuracy is that most Chinese Americans live closely within the community (e.g., Chinatown) and use a handful of Asian stores as their main food sources, which reduces the complexity of their food choices. Thus, collecting data from this ethnic group can provide an in-depth validation of eButton closed-loop feedback concept without excessive experimental time.
Who may be able to join
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Using Wearable Sensors and Artificial Intelligence for Carbohydrate Counting in Chinese Americans With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- eButton, Continuous Glucose Monitoring (CGM)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eButtonDevice
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
Also called FreeStyle Libre Pro model
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.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes group | Participants with Type 2 Diabetes will wear eButton and Continuous Glucose Monitoring (CGM) for 2 weeks and complete food diaries to record carb grams. Receives: Device: eButton; Device: Continuous Glucose Monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start18 Jul 2022
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaguang Zheng, PhD, RN, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335889
- Sponsor's protocol ID
- 21-01714
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Wearable Sensors and Artificial Intelligence for Carbohydrate Counting in Chinese Americans With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05335889
- Acronym / sponsor ID
- 21-01714
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes group | – | Device: eButton, Device: 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Americans participants are targeted to test eButton accuracy is that most Chinese Americans live closely within the community (e.g., Chinatown) and use a handful of Asian stores as their main food sources, which reduces the complexity of their food choices. Thus, collecting data from this ethnic group can provide an in-depth validation of eButton closed-loop feedback concept without excessive experimental time.
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eButtonThe 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. | Device | Type 2 Diabetes group |
| Continuous Glucose Monitoring (CGM)Also: FreeStyle Libre Pro modelThe 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. | Device | Type 2 Diabetes group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaguang Zheng, PhD, RN principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Carbohydrate Counting using eButton (absolute error) (time frame: Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.