臨床研究等提出・公開システム

Date of registration	Feb. 23, 2023
Last modified on	Feb. 23, 2023
Trial ID	jRCT1032220660

Scientific Title	Long-term effects of Hybrid Closed-loop System on Glycemic Control and Psychological Factors in Patients with Type 1 Diabetes Treated with Sensor Augmented Pump: A Prospective Single-Center Observational Study
Public Title	Long-term effects of Hybrid Closed-loop System on Glycemic Control and Psychological Factors in Patients with Type 1 Diabetes Treated with Sensor Augmented Pump: A Prospective Single-Center Observational Study

Contact for Scientific Queries	Name	Akiyama Tomoaki
	Affiliation	Yokohama city University Medical Center
	Address	4-57, Urafune-cho, Minami-ku, Yokohama city
	Telephone	+81-452615656
	E-mail	t_aki85@yokohama-cu.ac.jp
Contact for Public Queries	Name	Akiyama Tomoaki
	Affiliation	Yokohama city University Medical Center
	Address	4-57, Urafune-cho, Minami-ku, Yokohama city
	Telephone	+81-452615656
	E-mail	t_aki85@yokohama-cu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 23, 2023
Target sample size		23
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	people withh type 1 diabetes treated with sensor augmented pump who participanted in our previous trial, "Effects of Hybrid Closed-loop System on Glycemic Control and Psychological Factors in Patients with Type 1 Diabetes Treated with Sensor Augmented Pump: A Prospective Single-Center Observational Study" (Study period from 18, January, 2022 to 31, March, 2025)
	Exclusion Criteria	1 type 2 diabetes or secondary diabetes 2 patients with malignancies 3 drug-induced diabetes or current steroid therapy 4 patients who refused to participant in this study 5 patients who were regarded as inappropriate by the physicians
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		type 1 diabetes mellitus
Health Condition(s) Keyword		insulin pump
Health Condition(s) Code		D003922
Primary Outcome(s)		Effects of hybrid closed-loop system on psychological aspects
Secondary Outcome(s)		Time in range of glucose from 70 to 180mg/dl after 1 year starting hybrid closed-loop system

Primary Sponsor	Tadashi Yamakawa

Name of Certified Review Board	Yokohama City University Ethics Committee
Address	3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa
Telephone	+81-45-787-2800
E-Mail	rinri@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	Jan. 31, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none