Diabetes Mellitus Prediabetes Hyperglycemia Diabetes Mellitus Prediabetes Wearable Electronic Devices Blood Glucose Glucose Tolerance Test Early Diagnosis
Conditions
Interventions
Asymptomatic adults between 20 and 70 years of age with no prior clinical history or diagnosis of diabetes mellitus. Eligibility is confirmed by the participant providing official clinical laboratory
Screening
non-diabetic adults
Sponsors
Huawei Technologies (Thailand) Co. Ltd.
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Using the Huawei Fit5Pro smartwatch equipped with the Diabetes Risk Profile feature. 2. Must have successfully generated a Diabetes Risk Profile on their smartwatch within a maximum of two data collection cycles via the partner application 3. Adults aged 20 to70 years at the time of clinical enrolment. 4. Able to read, understand, and provide written electronic consent in Thai. 5. Willingness to undergo fasting clinical blood tests (HbA1c, FPG, Fasting Insulin, and OGTT) at the study site within 30 days of generating the digital risk profile. 6. Generally healthy adults with no known prior diagnosis of diabetes, able to provide blood test results that have been within 6 months
Exclusion criteria
Exclusion criteria: 1. Participants with a prior diagnosis of diabetes mellitus, including those diagnosed based on a positive Oral Glucose Tolerance Test (OGTT) 2. Participants with a history of gestational diabetes mellitus (GDM) in previous pregnancy. 3. Use of any glucose-lowering medications (e.g., Insulin, Metformin) or supplements that affect blood sugar levels. 4. Participants who are pregnant, breastfeeding, or planning to become pregnant during the 30-day study period. 5. Known allergy or significant skin sensitivity to the materials of the smart watch or its sensors (e.g., silicone, medical-grade steel). 6. Participants with ongoing participation in other interventional or observational clinical trials, particularly diabetes-related studies, at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between smartwatch-generated risk score and clinical glycemic status At the end of the 14-day study period (clinical assessment visit) smartwatch-generated diabetes risk tiers (Low/Medium/High) and) clinical biomarkers (HbA1c, Fasting Plasma Glucose, and 2-hour OGTT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between smartwatch risk and Insulin Resistance At the end of the 14-day study period (clinical assessment visit) smartwatch-generated diabetes risk tiers (Low/Medium/High) and) HOMA-IR | — |
Countries
Thailand
Contacts
Public ContactNich Paibulsirijit
Vitallife Scientific Wellness Center
Outcome results
None listed