Clinical Performance Study to Evaluate the Clinical Performance of the Salivary Glucose Monitoring System (DSLS-201), an in vitro Diagnostic Medical Device for Measuring (Blood) Glucose Using Saliva

A Single-Center, Prospective, Exploratory Clinical Performance Study to Evaluate the Clinical Performance of the Salivary Glucose Monitoring System (DSLS-201), an in vitro Diagnostic Medical Device for Measuring (Blood) Glucose Using Saliva

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011619

Enrollment

126

Registered

2026-02-13

Start date

2025-10-15

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : [Clinical Study Procedures (Three-Stage Process)] 1. Stage 1: Screening Phase The clinical performance study will be conducted over a 6-month screening period during which subjects wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Adults aged 19 to 85 years ? Individuals who voluntarily provide informed consent to participate in the exploratory clinical performance study and are willing and able to comply with the study protocol ? Individuals who have maintained a fasting period of at least 8 hours

Exclusion criteria

Exclusion criteria: ? Patients with severe oral diseases or salivary secretion disorders ? Individuals unable to provide legally valid voluntary consent ? Individuals who have participated in another clinical performance study within the past 30 days and received treatment with a drug or other medical device ? Individuals deemed by the investigator unlikely to successfully complete the exploratory clinical performance study (e.g., pregnant or breastfeeding women, or patients with oral disease–related conditions) ? Individuals with arrhythmia or those who have excessively engaged in exercise or medication intake

Design outcomes

Primary

Measure	Time frame
Correlation of test/control device glucose with reference device	—

Secondary

Measure	Time frame
Clinical performance for diabetes diagnosis(HbA1c): Sensitivity, Specificity, Accuracy, AUC	—

Countries

Korea, Republic of

Contacts

Public ContactJiyoung Yoon

Asan Medical Center

vouskfg512@naver.com+82-70-4818-8508

Outcome results