JRCT ID: jRCTs042220086
Registered date:01/11/2022
eBGM Study
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Type 2 Diabetes Mellitus |
Date of first enrollment | 01/11/2022 |
Target sample size | 80 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Using OneTouch Verio Reflect + OneTouch Reveal app |
Outcome(s)
Primary Outcome | Change in HbA1c from baseline to week 24 using OneTouch Reveal app |
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Secondary Outcome | 1)Change in body weight from baseline to week 24 2)Change in the percentage of blood glucose within the target range (70-180 mg/dL) calculated using the OneTouch Reveal app from baseline to week 24 3)Change in the number of SMBG measurements from baseline to week 24 4)Change in total insulin dose from baseline to week 24 5)Change in Diabetes Quality of Life Scale using DTR-QOL from baseline to week 24 |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | < 70age old |
Gender | Both |
Include criteria | Patients who meet all of the following criteria are induced in this study; 1)Patients with type2 diabetes mellitus 2)Patients who are between 18 and 70 years old at given their consent 3)Patients who have been diagnosed with type 2 diabetes for at least 6 months at given their consent 4)Patients with an HbA1c of 7.5% or higher but less than 10.0% at given their consent 5)Patients who have been using SMBG without BSM function for more than 3 months at given their consent 6)Patients who can use the mobile app function 7)Patients who have been on insulin therapy for more than 3 months at given their consent 8)Patients who are eligible for exercise therapy 9)Patients whose written consent to participate in the research has been obtained from them |
Exclude criteria | Patients who fall into any of the following criteria are excluded from participating in this study; 1)Patients with diabetes other than type 2 diabetes 2)Patients being treated with GLP-1 receptor agonists only (patients not using insulin) 3)Pregnant and lactating patients 4)Patients with a history of using SMBG with BSM function 5)Patients with a history of using mobile app features to treat diabetes 6)Patients with a history of hospitalization for any disease in the past 6 months 7)Patients with visual impairment 8)Patients with dementia or psychiatric disorders 9)Patients with alcoholism or drug addiction 10)Patients with severely impaired renal function at the time of registration (eGFR less than 30 mL/min) 11)Patients with severe hepatic dysfunction at the time of enrollment (blood levels of ALT, AST, or ALP greater than three times the upper limit of normal [ULN]) 12)Patients who are participating in other clinical research 13)Other patients who are judged by the principal investigator or sub-investigator to be unsuitable for this clinical research |
Related Information
Primary Sponsor | Yabe Daisuke |
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Secondary Sponsor | |
Source(s) of Monetary Support | LifeScan Japan Co. |
Secondary ID(s) |
Contact
Public contact | |
Name | Taro Fujisawa |
Address | 1-1 Yanagido, Gifu, Gifu Gifu Japan 501-1194 |
Telephone | +81-58-230-6373 |
l2001059_edu_gifu_dm@yahoo.co.jp | |
Affiliation | Gifu University Hospital |
Scientific contact | |
Name | Daisuke Yabe |
Address | 1-1 Yanagido, Gifu, Gifu Gifu Japan 501-1194 |
Telephone | +81-58-230-6373 |
daichan.yabechan@gmail.com | |
Affiliation | Gifu University Hospital |