Using an AI diet app to manage diabetes
Intervention Trial Using Artificial Intelligence(AI) Diet Application for Management of Diet in Diabetes Patients
This study is testing whether using an AI diet app along with a glucose monitor can help people with type 2 diabetes better control their blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | KangWon National University Hospital Academic / other |
| Locations | 1 site (Chuncheon, Kangwon) |
| Trial ID | NCT06089655 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of an artificial intelligence diet application combined with continuous glucose monitoring on blood sugar levels in patients with type 2 diabetes. Participants will be divided into three groups: a negative control group that only monitors hemoglobin A1c, a positive control group using a CGMS patch, and an intervention group utilizing both the CGMS and the AI diet app. The study aims to personalize dietary recommendations based on individual glucose responses to improve glycemic control. The trial will take place at Kangwon National University Hospital over a six-month period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 69 with type 2 diabetes who require dietary counseling and can use IoT devices for real-time glucose monitoring.
Not a fit: Patients with severe diabetes, those frequently changing medications, or individuals with communication barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood sugar management and personalized dietary strategies for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using technology for diabetes management, but this specific combination of AI and CGMS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - 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 Exclusion Criteria: 1. Patients with severe diabetes and have a lot of medication changes 2. Visitors to the emergency room of Kangwon National University Hospital 3. Patients with infectious diseases, including COVID-19 4. Vulnerable subjects (pregnant women, terminally ill patients, those who cannot communicate, etc.) 5. Patients with adverse reactions (allergies) to the Libre Continuous Glucose Monitoring System (CGMS) Criteria for suspension and elimination 1. Patients who withdrew their consent to the study during the study period or after the study was completed 2. Patients who need to change diabetes medication during the study period 3. 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.
Where this trial is running
Chuncheon, Kangwon
- Endocrinology department @ Kangwon National University Hospital — Chuncheon, Kangwon, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jiae Shin, PhD — Kangwon National University
- Study coordinator: Eunhee Cho, MD
- Email: ehcho@kangwon.ac.kr
- Phone: +82-33-258-9167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.