Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes

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.

Inclusion criteria

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

Exclusion criteria

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