Type 2 DiabetesNCT06089655
Intervention Trial Using Artificial Intelligence(AI) Diet Application for Management of Diet in Diabetes Patients
A study testing CGMS and AI diet application in people with Type 2 Diabetes, run by KangWon National University Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the intervention effects on blood sugar levels using an AI diet app for personalized meal control and the continuous glucose monitoring system (CGMS) in patients with type 2 diabetes (T2D) The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CGMS and AI diet application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2023to 30 May 2024
- Phase
- Interventional
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with T2D who visited Kangwon National University Hospital between August 2023 and March 2024.
- (Among outpatients between 18 and 69 years old who can continue to participate for six months)
- Individuals who can use an IoT device to check blood sugar in real time and send photos using a mobile phone and have no communication barriers
- Subjects who actively need dietary and nutritional counseling from their doctor due to poor blood sugar control with glycated hemoglobin (HbA1C) of 6.5% or higher
Who cannot join
- Patients with severe diabetes and have a lot of medication changes
- Visitors to the emergency room of Kangwon National University Hospital
- Patients with infectious diseases, including COVID-19
- Vulnerable subjects (pregnant women, terminally ill patients, those who cannot communicate, etc.)
- Patients with adverse reactions (allergies) to the Libre Continuous Glucose Monitoring System (CGMS)
- Criteria for suspension and elimination
Show all 10Show fewer
- Patients who withdrew their consent to the study during the study period or after the study was completed
- Patients who need to change diabetes medication during the study period
- Patients who arbitrarily stopped using the diabetic CGMS patch during the study period or did not participate in the meal survey app for more than 7 consecutive days
- Dropout Prevention Measures The dropout rate is expected to increase in the order of negative control group < positive control group < intervention group. In general, the dropout rate when selecting subjects in clinical trials is about 10% to 15%, but the dropout rate of subjects in this study is as high as 16.7%. Therefore, in order to prevent the dropout of the intervention group, which is expected to have the highest dropout rate, real-time monitoring is conducted on the collected blood glucose data. We are going to prevent the dropout as much as possible by proceeding in the direction of encouraging the target.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Endocrinology department @ Kangwon National University Hospital
Chuncheon, Gangwon-do, 24289
Eunhee Cho, MD, +82-33-258-9167, ehcho@kangwon.ac.kr
About this study
The goal of this clinical trial is to evaluate the intervention effects on blood sugar levels using an AI diet app for personalized meal control and the continuous glucose monitoring system (CGMS) in patients with type 2 diabetes (T2D)
The main questions it aims to answer are:
Read more
- Effect of glycemic control on hemoglobin A1c (HbA1c) in T2D patients through continuous glucose monitoring system (CGMS)
2 Effect of blood sugar management intervention using AI diet app
◎ Research method
<study arms>
- Negative Control group (NC) 20 people (*24 people) checking only hemoglobin A1c (HbA1c) three times (at the beginning of the study, after the 1st 12 weeks, and then after the 2nd 12weeks)
- Positive control group (PC) 30 people (*36 people) wearing the CGMS patch for 12 weeks and checking HbA1c three times
- Intervention group (IG) 30 people (*36 people) using CGMS patch for diabetes, AI diet app, and checking HbA1c three times (* Actual number of recruits considering dropout)
This study's aim is to identify dietary factors for each patient that can affect blood sugar control based on the Continuous Glucose Monitoring System (CGMS) in patients with T2D and to personalize the amount and type of meal intake. It is planned to confirm the effect of blood sugar control intervention through a nutrition counseling coaching system.
The sex-stratified random assignment method was used to recruit 20, 30, and 30 study participants in the control group (negative), control group (positive), and intervention group, respectively. Namely, each study group is allocated according to the endocrinology department visiting patients, so the ratio of participants by gender is similarly allocated.
The group allocation of subjects uses a double-blind method in which a researcher who is not at all related to research planning, analysis, and interpretation of results assigns subjects according to random sampling numbers.
Read the detailed description
This study aims to identify patient-specific dietary factors that can affect blood sugar control based on the continuous glucose monitoring system (CGMS) in T2D patients and to personalize the amount and type of meal intake.
[Research method]
<study arms>
- Negative Control group (NC) 20 people (*24 people) checking only hemoglobin A1c (HbA1c) three times (at the beginning of the study, after the 1st 12 weeks, and then after the 2nd 12weeks)
- Positive control group (PC) 30 people (*36 people) wearing the CGMS patch for 12 weeks and checking HbA1c three times
- Intervention group (IG) 30 people (*36 people) using CGMS patch for diabetes, AI diet app, and checking HbA1c three times
The sex-stratified random assignment method was used to recruit 20, 30, and 30 study participants in the control group (negative), control group (positive), and intervention group, respectively. Namely, each study group is allocated according to the endocrinology department visiting patients, so the ratio of participants by gender is similarly allocated.
The group allocation of subjects uses a double-blind method in which a researcher who is not at all related to research planning, analysis, and interpretation of results assigns subjects according to random sampling numbers.
[Research design]
Parallel design with three arms
◎ Effect evaluation criteria
- Based on the time of participation in the intervention study, the effect of CGMS and diet app intervention on blood sugar control in T2D patients will be evaluated by comparing HbA1c at each time point of CGMS intervention and AI diet intervention.
- In order to evaluate the difference in blood sugar control according to the use of CGMS, continuous blood sugar records of all CGMS users (PC + IG) for the first 12 weeks will be downloaded daily through the AI diet app and checked to observe irregularities in blood sugar control during the day. In addition, by checking the cumulative data for a week or a month, individual changes in blood sugar will be recorded and evaluated.
- To evaluate the blood sugar change according to the intervention using the AI Diet App, IG users' meal records will be downloaded every day, the meal characteristics according to the blood sugar change of CGMS will be identified, and the GL (glycemic index) or GL (glycemic load) will be calculated.
- This process includes counseling in which a professional nutritionist sends a text message for individual blood sugar control meals based on an AI diet app and a CGMS app. In addition, the investigators will evaluate the effect of these interventions on glycemic control by measuring HbA1c
- The effect of dietary intervention without CGMS for another 12 weeks after the first 12 weeks with CGMS is evaluated in T2D patients by measuring HbA1c before and after implementing only dietary intervention.
< Data items to be collected >
(1) Surveys three times*
- Demographic information: abbreviation of name, gender, date of birth, occupation, education, income, marital status, number of children, female history (menopause, uterine/ovarian removal)
- Disease history*: comorbidities, complications, antidiabetic drugs, duration of illness
- Nutrition practices*: Number of meals/days, whether or not to eat out, dining out location, main food intake
- Lifestyle*: sleep, smoking, alcohol consumption, exercise, physical activity
- Diabetes Self-Management Activities*: Execute meal plan, exercise, blood sugar test, diabetes medication, foot care (In the case of *, it is conducted at the beginning, after 12 weeks, and at the end.)
- App: Daily meal information
- Blood sugar: Continuous blood sugar information through CGMS patch
<Consideration of safety for research participants>
- Basic procedures to secure research ethics This study complies with the Declaration of Helsinki and ICH-GCP and will be conducted after IRB approval.
- Personal information plan for research subjects
Personal information that can be collected in this study includes name, initials, sex, year of birth, contact information, and account number.
Personal information is used for research through deletion or anonymization and is only accessible to authorized researchers.
Individual identification through the use of the data built up is impossible, and the information obtained from the research will not be used for purposes other than confirming or researching the occurrence of diseases in the future.
<Research participant incentives>
Negative control group: 40,000 won for clinical participation Positive control group: 60,000 won for clinical participation Intervention group: 100,000 won for clinical participation
- Conditions
- Type 2 Diabetes
- Being tested
- CGMS, AI diet application
- 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.
CGMSDevice
Also called Libre patch group
The Intervention group is to use CGMS to estimate the effect on blood glucose (HbA1C).
AI diet applicationBehavioural
Also called Diet advice
The Intervention group is to use an AI diet application to estimate the effect on blood glucose (HbA1C).
| Study group | Role | What they receive |
|---|---|---|
| Negative control | No intervention | no continuous glucose monitoring system nor AI diet application |
| Positive control | Active comparator | Continuous glucose monitoring system only Receives: Device: CGMS |
| Intervention | Experimental | Continuous glucose monitoring system +AI diet application Receives: Device: CGMS; Behavioral: AI diet application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of blood glucose level from the effect of wearing CGMS patch
Checking the blood glucose by measuring HbA1c whether there would be a significant changes between Negative control + positive control and intervention group.
Measured: At the beginning of the study, in 12 weeks, and then after another 12 weeks
The change of blood glucose level from diet consulting
The effect of diet change
Measured: At the beginning of the study, in 12 weeks, and then after another 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Sep 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 May 2024 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KangWon National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kangwon National University
- Responsible party
- Sponsor
- Investigators
- Jiae Shin, PhD, Principal investigator, Kangwon National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089655
- Sponsor's protocol ID
- KangWonNUH
- Status last verified
- Oct 2023
- First submitted
- 6 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Trial Using Artificial Intelligence(AI) Diet Application for Management of Diet in Diabetes Patients
- ClinicalTrials.gov ID
- NCT06089655
- Acronym / sponsor ID
- KangWonNUH
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- KangWon National University HospitalUniversity, hospital or other
- Collaborators
- Kangwon National University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 18 Oct 2023 (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.
The goal of this clinical trial is to evaluate the intervention effects on blood sugar levels using an AI diet app for personalized meal control and the continuous glucose monitoring system (CGMS) in patients with type 2 diabetes (T2D)
The main questions it aims to answer are:
- Effect of glycemic control on hemoglobin A1c (HbA1c) in T2D patients through continuous glucose monitoring system (CGMS)
2 Effect of blood sugar management intervention using AI diet app
◎ Research method
<study arms>
- Negative Control group (NC) 20 people (*24 people) checking only hemoglobin A1c (HbA1c) three times (at the beginning of the study, after the 1st 12 weeks, and then after the 2nd 12weeks)
- Positive control group (PC) 30 people (*36 people) wearing the CGMS patch for 12 weeks and checking HbA1c three times
- Intervention group (IG) 30 people (*36 people) using CGMS patch for diabetes, AI diet app, and checking HbA1c three times (* Actual number of recruits considering dropout)
This study's aim is to identify dietary factors for each patient that can affect blood sugar control based on the Continuous Glucose Monitoring System (CGMS) in patients with T2D and to personalize the amount and type of meal intake. It is planned to confirm the effect of blood sugar control intervention through a nutrition counseling coaching system.
The sex-stratified random assignment method was used to recruit 20, 30, and 30 study participants in the control group (negative), control group (positive), and intervention group, respectively. Namely, each study group is allocated according to the endocrinology department visiting patients, so the ratio of participants by gender is similarly allocated.
The group allocation of subjects uses a double-blind method in which a researcher who is not at all related to research planning, analysis, and interpretation of results assigns subjects according to random sampling numbers.
Detailed description
This study aims to identify patient-specific dietary factors that can affect blood sugar control based on the continuous glucose monitoring system (CGMS) in T2D patients and to personalize the amount and type of meal intake.
[Research method]
<study arms>
- Negative Control group (NC) 20 people (*24 people) checking only hemoglobin A1c (HbA1c) three times (at the beginning of the study, after the 1st 12 weeks, and then after the 2nd 12weeks)
- Positive control group (PC) 30 people (*36 people) wearing the CGMS patch for 12 weeks and checking HbA1c three times
- Intervention group (IG) 30 people (*36 people) using CGMS patch for diabetes, AI diet app, and checking HbA1c three times
The sex-stratified random assignment method was used to recruit 20, 30, and 30 study participants in the control group (negative), control group (positive), and intervention group, respectively. Namely, each study group is allocated according to the endocrinology department visiting patients, so the ratio of participants by gender is similarly allocated.
The group allocation of subjects uses a double-blind method in which a researcher who is not at all related to research planning, analysis, and interpretation of results assigns subjects according to random sampling numbers.
[Research design]
Parallel design with three arms
◎ Effect evaluation criteria
- Based on the time of participation in the intervention study, the effect of CGMS and diet app intervention on blood sugar control in T2D patients will be evaluated by comparing HbA1c at each time point of CGMS intervention and AI diet intervention.
- In order to evaluate the difference in blood sugar control according to the use of CGMS, continuous blood sugar records of all CGMS users (PC + IG) for the first 12 weeks will be downloaded daily through the AI diet app and checked to observe irregularities in blood sugar control during the day. In addition, by checking the cumulative data for a week or a month, individual changes in blood sugar will be recorded and evaluated.
- To evaluate the blood sugar change according to the intervention using the AI Diet App, IG users' meal records will be downloaded every day, the meal characteristics according to the blood sugar change of CGMS will be identified, and the GL (glycemic index) or GL (glycemic load) will be calculated.
- This process includes counseling in which a professional nutritionist sends a text message for individual blood sugar control meals based on an AI diet app and a CGMS app. In addition, the investigators will evaluate the effect of these interventions on glycemic control by measuring HbA1c
- The effect of dietary intervention without CGMS for another 12 weeks after the first 12 weeks with CGMS is evaluated in T2D patients by measuring HbA1c before and after implementing only dietary intervention.
< Data items to be collected >
(1) Surveys three times*
- Demographic information: abbreviation of name, gender, date of birth, occupation, education, income, marital status, number of children, female history (menopause, uterine/ovarian removal)
- Disease history*: comorbidities, complications, antidiabetic drugs, duration of illness
- Nutrition practices*: Number of meals/days, whether or not to eat out, dining out location, main food intake
- Lifestyle*: sleep, smoking, alcohol consumption, exercise, physical activity
- Diabetes Self-Management Activities*: Execute meal plan, exercise, blood sugar test, diabetes medication, foot care (In the case of *, it is conducted at the beginning, after 12 weeks, and at the end.)
- App: Daily meal information
- Blood sugar: Continuous blood sugar information through CGMS patch
<Consideration of safety for research participants>
- Basic procedures to secure research ethics This study complies with the Declaration of Helsinki and ICH-GCP and will be conducted after IRB approval.
- Personal information plan for research subjects
Personal information that can be collected in this study includes name, initials, sex, year of birth, contact information, and account number.
Personal information is used for research through deletion or anonymization and is only accessible to authorized researchers.
Individual identification through the use of the data built up is impossible, and the information obtained from the research will not be used for purposes other than confirming or researching the occurrence of diseases in the future.
<Research participant incentives>
Negative control group: 40,000 won for clinical participation Positive control group: 60,000 won for clinical participation Intervention group: 100,000 won for clinical participation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blinded randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Negative control | No intervention | –no continuous glucose monitoring system nor AI diet application |
| Positive control | Active comparator | Device: CGMSContinuous glucose monitoring system only |
| Intervention | Experimental | Device: CGMS, Behavioral: AI diet applicationContinuous glucose monitoring system +AI diet application |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with T2D who visited Kangwon National University Hospital between August 2023 and March 2024.
- (Among outpatients between 18 and 69 years old who can continue to participate for six months)
- Individuals who can use an IoT device to check blood sugar in real time and send photos using a mobile phone and have no communication barriers
- Subjects who actively need dietary and nutritional counseling from their doctor due to poor blood sugar control with glycated hemoglobin (HbA1C) of 6.5% or higher
Key exclusion criteria (10 listed)
- Patients with severe diabetes and have a lot of medication changes
- Visitors to the emergency room of Kangwon National University Hospital
- Patients with infectious diseases, including COVID-19
- Vulnerable subjects (pregnant women, terminally ill patients, those who cannot communicate, etc.)
- Patients with adverse reactions (allergies) to the Libre Continuous Glucose Monitoring System (CGMS)
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 |
|---|---|---|
| CGMSAlso: Libre patch groupThe Intervention group is to use CGMS to estimate the effect on blood glucose (HbA1C). | Device | Intervention, Positive control |
| AI diet applicationAlso: Diet adviceThe Intervention group is to use an AI diet application to estimate the effect on blood glucose (HbA1C). | Behavioural | Intervention |
Primary outcome
The change of blood glucose level from the effect of wearing CGMS patch
Time frame: At the beginning of the study, in 12 weeks, and then after another 12 weeks
Checking the blood glucose by measuring HbA1c whether there would be a significant changes between Negative control + positive control and intervention group.
The change of blood glucose level from diet consulting
Time frame: At the beginning of the study, in 12 weeks, and then after another 12 weeks
The effect of diet change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Jiae Shin, PhD principal investigator
Kangwon National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGMS and AI diet application in people with Type 2 Diabetes, run by KangWon National University Hospital at 1 site in South Korea.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunhee Cho, MD (+82-33-258-9167, ehcho@kangwon.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of blood glucose level from the effect of wearing CGMS patch (time frame: At the beginning of the study, in 12 weeks, and then after another 12 weeks). The study lists 2 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 18 Oct 2023; AzTrials last refreshed its copy on 5 Nov 2026.