Type 2 Diabetes (T2DM)NCT07781683
Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes
An observational study of Type 2 Diabetes (T2DM), run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.
Who may be able to join
- Aged between 18 and 80 years.
- Individuals without a history of diabetes, or patients with type 2 diabetes mellitus.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Hang Su, MD, 02164369181, suhang@shsmu.edu.cn
About this study
Official title: Development and Application of a Novel Noninvasive Salivary 1,5-Anhydroglucitol Detection Technology in Diabetes Management
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.
Read the 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.
- Conditions
- Type 2 Diabetes (T2DM)
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Salivary 1,5-Anhydroglucitol and Glycemic Levels
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.
Measured: Screening
Secondary outcomes (2)
Correlation Between Salivary and Serum 1,5-Anhydroglucitol Levels
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.
Measured: Screening
Correlation Between Salivary 1,5-Anhydroglucitol and Continuous Glucose Monitoring Metrics
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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781683
- Sponsor's protocol ID
- 20260820
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Novel Noninvasive Salivary 1,5-Anhydroglucitol Detection Technology in Diabetes Management
- ClinicalTrials.gov ID
- NCT07781683
- Acronym / sponsor ID
- 20260820
- Conditions
- Type 2 Diabetes (T2DM)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.
Key inclusion criteria (2 listed)
- Aged between 18 and 80 years.
- Individuals without a history of diabetes, or patients with type 2 diabetes mellitus.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Salivary 1,5-Anhydroglucitol and Glycemic Levels
Time frame: 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.
2 secondary outcomes
Correlation Between Salivary and Serum 1,5-Anhydroglucitol Levels
Time frame: Screening
Correlation Between Salivary 1,5-Anhydroglucitol and Continuous Glucose Monitoring Metrics
Time frame: One week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes (T2DM), run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hang Su, MD (+86-021-64369181, suhang@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Salivary 1,5-Anhydroglucitol and Glycemic Levels (time frame: Screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.