臨床研究等提出・公開システム

Date of registration	Dec. 03, 2023
Last modified on	Sept. 02, 2024
Trial ID	jRCT1032230486

Scientific Title	Questionnaire survey on the use of the OneDrawTM automated blood collection and storage device in patients with type 2 diabetes
Public Title	Not applicable

Contact for Scientific Queries	Name	Seiji Hori
	Affiliation	Sumitomo Pharma Co., Ltd.
	Address	6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan
	Telephone	+81-120-034-389
	E-mail	fbo_ir@sumitomo-pharma.co.jp
Contact for Public Queries	Name	Masaki Hashimoto
	Affiliation	Sumitomo Pharma Co., Ltd.
	Address	7-1, Nihonbashi 2-chome, Chuo-ku, Tokyo 103-6012, Japan
	Telephone	+81-3-5205-3720
	E-mail	fbo_ir@sumitomo-pharma.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Oct. 16, 2023
Actual date of first enrollment		Oct. 16, 2023
Target sample size		30
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 diabetes
Primary Outcome(s)		Results of a survey on the use of the OneDra for patients with type 2 diabetes

Primary Sponsor	Sumitomo Pharma Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Non Profit Organization Tokyo Allergy and Respiratory Disease Research Institute
Address	8-6, Kuramae 2-chome, Taito-ku, Tokyo, Japan, Tokyo
Telephone	+81-70-3894-3785
E-Mail	takahiro.chisaki@inclusion-p.com
Approval Status	Approval
Date of approval	Aug. 25, 2023

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
3	Sept. 02, 2024	(this page)	Changes
2	Mar. 28, 2024	Detail	Changes
1	Dec. 03, 2023	Detail

List of change history