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An examination of the operational feasibility and effectiveness of remote monitoring of salivary glycated albumin using a smartphone app for glycemic management in a social implementation project.

Social implementation study of a smartphone app for remote monitoring of salivary glycated albumin to support glycemic management

Minoura Itsushi

Provigate Inc.

5F, Todaimae HiRAKU GATE, 2-3-10 Mukogaoka, Bunkyoi-ku, Tokyo 113-0023

ozu-p-project@provigate.com

Minoura Itsushi

Provigate Inc.

5F, Todaimae HiRAKU GATE, 2-3-10 Mukogaoka, Bunkyoi-ku, Tokyo 113-0023

+81-3-5615-8285

ozu-p-project@provigate.com

Recruiting

July. 20, 2026

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

health services research

Participants who meet all of the following criteria will be eligible for this study:
1) The most recent HbA1c test result from a health checkup or outpatient test is 5.6% or higher.
2) Aged 20 years or older at the time of informed consent.
3) Owns a smartphone capable of running the required application.
4) Has the intention to improve their lifestyle habits.
5) Able to self-collect saliva samples at home on designated days during the weekly measurement period, and promptly drop them off in a refrigerated post box located at a post office.
6) Able to collect and submit saliva samples and complete questionnaires at baseline (start), at the end of the weekly measurement period, and at the end of the follow-up period.
7) Understands the contents of the informed consent document explaining the study's purpose and methodology, and has provided written consent to participate.
8) If currently receiving outpatient treatment for diabetes, has obtained written approval from their primary care physician to participate in this study.

Individuals who meet any of the following criteria will be excluded from the study:
1) Currently hospitalized for medical treatment.
2) Having comorbid conditions or symptoms known to cause a discrepancy between GA (glycated albumin) levels and blood glucose levels (hyperthyroidism, nephrotic syndrome, ascites [peritoneal dialysis], steroid-induced diabetes, high BMI, hypothyroidism, liver cirrhosis, or malnutrition).
3) Having special dietary or exercise restrictions prescribed by a physician due to other symptoms or conditions, and whose participation is deemed difficult by the Principal Investigator.
4) Otherwise judged inappropriate for participation by the Principal Investigator.

Both

Impaired Glucose Tolerance, and Diabetes

The following data, obtained from a social implementation project jointly conducted by local govrnment, post offices, and corporate partners, will be collected, observed, and evaluated:
1) Baseline (at start): Acquire health checkup data (e.g., HbA1c levels) and evaluate lifestyle habits using a questionnaire.
2) Conduct interviews in-person, by telephone, or online. Qualified healthcare professionals (e.g., nurses, registered dietitians) will interview participants about their current lifestyle habits and assist them in entering self-determined behavioral goals for lifestyle improvement into the app.
3) Weekly measurement period (8 weeks): Participants will self-collect saliva samples for glycated albumin (GA) measurement once a week, drop them off in a dedicated post box located at a post office, and receive their measurement results alongside general lifestyle information through a dedicated app.
4) Follow-up period (16 to 20 weeks after start): Re-measure salivary GA and have participants complete a questionnaire regarding their lifestyle habits.

D018149, D003920

D063731

Difference in the rate of change in salivary GA levels between the weekly measurement period and the follow-up period.

Correlation between salivary GA levels and HbA1c levels
Evaluation of behavioral changes in lifestyle habits
Relationship between app engagement and GA improvement rate)
Assessment of subjective usefulness and acceptability

+81-6-6395-9000

July. 10, 2026

Yes

The research findings obtained from this study are planned to be published through academic conference presentations, scientific papers, and other appropriate channels. Prior to such publications, additional data analysis may be commissioned to researchers at a university research institution. Should this additional analysis be conducted, a separate ethical review will be performed. Furthermore, only the minimum pseudonymized data necessary for the analysis will be provided, and no personally identifiable information will be shared.

None