eBGM Study

JRCT ID: jRCTs042220086

Registered date:01/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 01/11/2022
• Target sample size: 80
• 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

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
• Age maximum: < 75age 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 75 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
• Source(s) of Monetary Support: LifeScan Japan Co.