Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059199) titled 'A Study on the Correlation Between HbA1c Levels and Glycated Albumin Levels in Blood and Saliva Using Average Blood Glucose Levels' on Sept. 30.
Study Type:
Observational
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - diabetes mellitus
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We have reported on the usefulness of diabetes management methods using glycated albumin (GA) levels, which reflect average blood glucose levels over the preceding few weeks.
However, evidence regarding diabetic complications has primarily been reported using HbA1c levels, necessitating clarification of the relationship between HbA1c and GA levels.
In recent years, continuous glucose monitoring (CGM) has enabled detailed assessment of blood glucose fluctuations over a specific period.
Therefore, we decided to use CGM to measure average blood glucose levels and conduct a detailed analysis of the correlation between HbA1c levels and GA levels in blood and saliva.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - - Male and female aged 20 years or older
- Diabetes patients with HbA1c of 6% or higher (type of diabetes not specified)
- Participants capable of self-installing a CGM sensor and owning a smartphone compatible with the CGM app, as well as installing and using the app
- Participants capable of self-collecting fingerstick blood and saliva samples and mailing them
Key exclusion criteria - - Participants who do not wish to be informed of any unexpected findings
- Participants with HbA1c levels below 6% in screening tests
- Participants testing positive for HIV, hepatitis B, hepatitis C, or syphilis in infectious disease tests
- Participants with conditions affecting HbA1c or GA levels (e.g., blood disorders, liver/kidney disease)
- Participants deemed unable to continue participation following a physician's examination
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 18 Day
Anticipated trial start date - 2025 Year 09 Month 30 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067707
Disclaimer: Curated by HT Syndication.