Type I and Type II diabetic patients
Conditions
Interventions
Blood sugar measurement (New glucose measurement system) Blood sugar measurement (Existing glucose measurement system)
Sponsors
ARKRAY, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 years or over and under 70 years (at the time of consent) 2. Patients with HbA1c of 6% or higher (patients with higher levels are preferred) 3. Male or female (regardless of sex) 4. Patients who have sufficient understanding and can provide voluntary written consent for participation in the study after sufficient explanation
Exclusion criteria
Exclusion criteria: 1. Patients with diabetes related complications (if not attending hospital due to complications and living a normal lifestyle, the patient can be registered; however, if diabetic neuropathy is detected during the study, the patient will be discontinued from the study) 2. Patients with skin disease at the evaluation site 3. Patients currently undergoing the xylose absorption test 4. Patients currently taking pralidoxime methiodide 5. Patients currently participating in another clinical trial 6. Patients who are otherwise judged to be unsuitable for this clinical trial by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Correlation between the values measured by the test system (test group) and the values measured by existing system 2. Difference depending on test system application site | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Condition around measurement site 2. Stability of the test system 3. Questionnaire survey (sense of use, pain, points of improvement etc.) Safety evaluation outcomes 1. Presence or absence of study equipment (test system and control system) defects and their frequency 2. Adverse events and side effects, and their frequency | — |
Countries
Japan
Contacts
Public ContactMakoto Arai
Mebix, Inc. Research Promotion Division
Outcome results
None listed