Type 2 Diabetes Mellitus
Conditions
Interventions
Using OneTouch Verio Reflect + OneTouch Reveal app
OneTouch Verio Reflect, OneTouch Reveal app
Sponsors
Kato Takehiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are induced in this study; 1)Patients with type2 diabetes mellitus 2)Patients who are over 18 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 or GLP-1 receptor agonist injection 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
Exclusion criteria
Exclusion 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)Pregnant and lactating patients 3)Patients with a history of using SMBG with BSM function 4)Patients with a history of using mobile app features to treat diabetes 5)Patients with a history of hospitalization for any disease in the past 6 months 6)Patients with visual impairment 7)Patients with dementia or psychiatric disorders 8)Patients with alcoholism or drug addiction 9)Patients with severely impaired renal function at the time of registration (eGFR less than 30 mL/min) 10)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]) 11)Patients who are participating in other clinical research 12)Other patients who are judged by the principal investigator or sub-investigator to be unsuitable for this clinical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to week 24 using OneTouch Reveal app | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTaro Fujisawa
Gifu University Hospital
Outcome results
None listed