Not applicable

JRCT ID: jRCT1032230486

Registered date:03/12/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 16/10/2023
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: Results of a survey on the use of the OneDra for patients with type 2 diabetes

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be considered.
1) Age 18 years or older on the date of consent, regardless of gender
2) Outpatients with mild to moderate type 2 diabetes whose condition is stable
3) Patients who are able to adhere to medication adherence and diet and exercise regimen as directed
4) Patients with HbA1c less than 8.0% on the last 2 diabetes examinations prior to obtaining consent
5) Patients who have not changed their diabetes medications since the two previous visits at the time of obtaining consent and have no plans to do so until the end of this study
6) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding

Exclude criteria

Patients who violate the following criteria will be excluded from this study.
1) Patients with type I diabetes mellitus
2) Patients on insulin therapy
3) Patients who may exhibit severe ketosis, diabetic coma or pre-comatose state during study participation
4) Patients with unstable HbA1c levels
5) Patients with restrictions on diet and exercise due to other diseases or complications
6) Patients who are pregnant, lactating, may be pregnant, or are planning to become pregnant
7) Patients with impaired hemostatic function due to bleeding disorder or medication, or with shock or allergy
8) Other patients deemed by the physician to be ineligible for participation

Related Information

• Primary Sponsor: Seiji Hori