臨床研究等提出・公開システム

Date of registration	Aug. 07, 2024
Last modified on	June. 10, 2025
Trial ID	jRCT1022240017

Scientific Title	Evaluation of the artificial intelligence (AI) for predicting optimized insulin dosage in diabetic patients
Public Title	Evaluation of the artificial intelligence (AI) for predicting optimized insulin dosage in diabetic patients

Completion date	Oct. 24, 2024
Result actual enrolment	130

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1022240017

Contact for Scientific Queries	Name	Katagiri Hideki
	Affiliation	Tohoku University Graduate School of Medicine
	Address	2-1, Seiryo-machi, Aoba-ku, Sendai
	Telephone	+81-22-717-7611
	E-mail	katagiri@med.tohoku.ac.jp
Contact for Public Queries	Name	Takahashi Kei
	Affiliation	Tohoku University Graduate School of Medicine
	Address	2-1, Seiryo-machi, Aoba-ku, Sendai
	Telephone	+81-22-717-7611
	E-mail	kei.takahashi.b4@tohoku.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 07, 2024
Target sample size		130
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Clinical data of hospitalized type 2 diabetes patients who received insulin therapy from diabetologists will be collected, provided they meet all the following eligibility criteria and do not fall under any exclusion criteria. Eligibility Criteria: (1) Patients using ultra-rapid-acting insulin and long-acting insulin (insulin glargine, insulin degludec) (2) Patients aged 20 years or older (3) Patients who have provided written consent to participate in the study (4) Patients with a hospital stay of 7 days or more
	Exclusion Criteria	(1) Patients who are pregnant or may be pregnant (2) Patients with or suspected of having diabetic gastroparesis (3) Patients with severe diabetic autonomic neuropathy (4) Patients with pre-proliferative diabetic retinopathy or proliferative diabetic retinopathy, or suspected of having these conditions (5) Patients undergoing continuous subcutaneous insulin infusion therapy or continuous intravenous insulin infusion (6) Patients who have not been discharged since undergoing general anesthesia surgery (7) Patients with missing data in the specified input data without any reason such as tests (8) Patients whose primary purpose is not blood glucose control (9) For cases from Tohoku University Hospital, data from hospitalizations before 2021 (as these data may have been used for the training of the experimental device)
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 Diabetes
Health Condition(s) Code		D003924
Primary Outcome(s)		Correct rate: Rate when the difference between the test device and the units prescribed by diabetologists is within the acceptable range.

Primary Sponsor	Renascience Inc.

Source of Monetary Support / Secondary Sponsor	AMED
Secondary Sponsor	Not applicable

Source of Monetary Support	Renascience Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Committee of Tohoku University Graduate School of Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Approval Status	Approval
Date of approval	Aug. 01, 2024

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 10, 2025	(this page)	Changes
1	Aug. 07, 2024	Detail

List of change history