臨床研究等提出・公開システム

Date of registration	April. 13, 2026
Last modified on	April. 13, 2026
Trial ID	jRCT1030260040

Scientific Title	Feasibility study of a care program for people with type 2 diabetes who Discontinue Consult a Doctor.
Public Title	Considering the implementation of a care program for people with type 2 diabetes who have previously discontinued treatment.

Contact for Scientific Queries	Name	Yoneda Akiko
	Affiliation	Yamanashi Prefectural University
	Address	1-6-1 Ikeda, Kofu City, Yamanashi Prefecture, Yamanashi Prefectural University
	Telephone	+81-9078113008
	E-mail	yonedaok@yamanashi-ken.ac.jp
Contact for Public Queries	Name	Amemiya Moe
	Affiliation	Yamanashi Prefectural University
	Address	1-6-1 Ikeda, Kofu City, Yamanashi Prefecture, Yamanashi Prefectural University
	Telephone	+81-55-253-7780
	E-mail	m-amemiya@yamanashi-ken.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		April. 13, 2026
Target sample size		20
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patient Diagnosed with type 2 diabetes Has had a treatment interruption of 4 months or more Male, aged 30 to under 70 Has given written consent to participate in the study
	Exclusion Criteria	Patient Has severe diabetic complications (receiving dialysis, blind in both eyes, history of lower limb amputation (major amputation)) Receiving cancer treatment Has been diagnosed with dementia Resides in a nursing home Has difficulty communicating and answering questionnaires Unemployed (at time of recruitment) HbA1c less than 6.5% (at time of recruitment) HbA1c 10% or higher, and positive for urinary ketones
	Age Minimum	30age old over
	Age Maximum	70age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Has had a treatment interruption of 4 months or more
Intervention(s)		The intervention will utilize a care program developed by researchers for individuals who have experienced treatment interruption.
Intervention(s) Keyword		care prgram
Health Condition(s) Code		D003924
Primary Outcome(s)		Success rate in avoiding repeated treatment interruptions (treatment status 6 months after completion of care program: continuation of regular check-ups)
Secondary Outcome(s)		Medical consultation status: Interval and frequency of visits, presence and number of missed appointments, status of appointment changes (telephone, internet, in-person visit, etc.), presence of nighttime or emergency visits, number of unscheduled visits to the relevant department, number of visits to other medical institutions, presence of hospitalization, status of appointment changes to suit convenience Self-care ability: IDSCA HbA1c Random blood glucose Blood pressure Weight, body size (BMI) Care program implementation status (time, duration, order of care) Opinions and feedback on participation in and intervention in the care program

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics Review Committee, Faculty of Nursing, Yamanashi Prefectural University
Address	1-6-1 Ikeda, Kofu City, Yamanashi Prefecture, Yamanashi Prefectural University, Yamanashi
Telephone	+81-55-253-7780
E-Mail	h-nonaka@yamanashi-ken.ac.jp
Approval Status	Not approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none