Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Type 2 Diabetes (T2DM)

Study type: Observational

Funder types: Other

Identifiers

NCT07781683

20260820

Details and patient eligibility

About

The goal of this observational study is to evaluate the clinical value of salivary 1,5-anhydroglucitol (1,5-AG) and assess a novel noninvasive detection approach in individuals with and without type 2 diabetes. Additionally, the study will examine the relationships of salivary 1,5-AG with serum 1,5-AG and continuous glucose monitoring (CGM) measures of short-term glycemic control and fluctuations.

Full description

Serum 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic status and is particularly sensitive to recent hyperglycemic excursions. Saliva offers a noninvasive and convenient alternative for repeated metabolic monitoring, but the clinical application of salivary 1,5-AG has been limited by challenges in detection accuracy and standardization. This study therefore aims to evaluate the clinical value of salivary 1,5-AG and a novel noninvasive detection approach. First, the study will assess salivary 1,5-AG levels and compare the novel detection approach with reference measurements. Second, it will evaluate the relationships of salivary 1,5-AG with serum 1,5-AG and continuous glucose monitoring (CGM) metrics to determine its potential for reflecting short-term glycemic fluctuations and glycemic control.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 80 years.
2. Individuals without a history of diabetes, or patients with type 2 diabetes mellitus.

Exclusion criteria

1. History of systemic glucocorticoid treatment within the previous 6 weeks.
2. Presence of acute infection.
3. Presence of severe oral conditions that may affect saliva collection or measurement.
4. Presence of severe hepatic or renal dysfunction.
5. History of alcohol abuse or psychiatric disorders, including depression.
6. Current treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors.