Clinical Trial: Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels (Japan)

Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060136) titled 'Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels' on Dec. 22.

Study Type: Observational

Primary Sponsor: Institute - Suntory Global Innovation Center Ltd.

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective is to acquire device measurements and blood glucose levels and to confirm the accuracy Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy male and female whose ages are 20 to <65 years old. (2) Individuals who have undergone a health checkup or comprehensive medical examination within the past 12 months (3) Subjects who agree with the given description and express informed consent via telecommunication and written documents. Key exclusion criteria - 1.Systolic pressure <90 mmHg 2.pregnant or lactating. 3.Individuals with a fasting blood glucose level of 126 mg/dL or higher in their most recent health checkup or comprehensive medical examination 4.Individuals whose BMI was less than 18.5 kg/m2 or 30.0 kg/m2 or higher in their most recent health checkup or comprehensive medical examination 5.Individuals whose HbA1c (hemoglobin A1c) level was 6.5% or higher in their most recent health checkup or comprehensive medical examination 6.Subjects who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study. 7.Male Subjects who donated over 400ml whole blood within the past 12 weeks prior to the current study. 8.Female who donated over 400ml whole blood within the past 16 weeks prior to the current study. 9.Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 10.Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 11.participating in other clinical studies, or who finished clinical study within the last 4 weeks. 12a.disease on heart, liver, kidney or other organs complications. 12b.a previous history of disease on circulatory organs. 12c.diabetes. 13.gastrointestinal diseases and/or a history of surgery affecting digestion and absorption 14.alcohol sensitivity 15.a previous history of feeling sick after blood sampling. 16.metal and/or latex allergic contact dermatitis 17.allergies to glucose tolerance. 18.have had an abnormal ECG (arrhythmia) indicated in the past. 19.are constantly taking certain drug medicine, 20.drink alcohol a lot 21.work irregular shifts or at midnight. 22.judged as unsuitable for the study by the principal investigator for other reasons. Target Size - 65

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 04 Day Anticipated trial start date - 2025 Year 12 Month 19 Day Last follow-up date - 2026 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068781

Disclaimer: Curated by HT Syndication.