Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes

Development and Application of a Novel Noninvasive Salivary 1,5-Anhydroglucitol Detection Technology in Diabetes Management

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07781683

Enrollment

180

Registered

2026-08-24

Start date

2026-09-01

Completion date

2028-12-31

Last updated

2026-08-25

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

Conditions

Type 2 Diabetes (T2DM)

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Correlation Between Salivary 1,5-Anhydroglucitol and Glycemic Levels	Screening	Salivary 1,5-anhydroglucitol (1,5-AG) will be measured by liquid chromatography-mass spectrometry or enzymatic assay. Glycemic levels will be assessed by fasting plasma glucose (mmol/L), glycated hemoglobin A1c (HbA1c, %), and glycated albumin (GA, %). Pearson or Spearman correlation coefficients will be used to assess their correlations with salivary 1,5-AG.

Secondary

Measure	Time frame	Description
Correlation Between Salivary and Serum 1,5-Anhydroglucitol Levels	Screening	Salivary 1,5-AG will be measured by LC-MS or enzymatic assay, and serum 1,5-AG will be measured by enzymatic assay. Pearson or Spearman correlation coefficients will be calculated.
Correlation Between Salivary 1,5-Anhydroglucitol and Continuous Glucose Monitoring Metrics	One week	Salivary 1,5-AG will be measured by LC-MS or enzymatic assay. CGM metrics will include time in range (TIR), time in tight range (TITR), and time above range (TAR), expressed as percentages.

Countries

China

Contacts

CONTACTHang Su, MD

suhang@shsmu.edu.cn+86-021-64369181

Outcome results