UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for the Efficacy Assessment of the Standard Diabetes Manual
Title of the study (Brief title)	SEAS-DM
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of the Standard Diabetes Manual issued by National Center for Global Health and Medicine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of the following test performance: 1. Evaluation of retinopathy by an ophthalmologist (once a year) 2. Measurement of urinary albumin excretion (every 6 months) 3. Measurement of serum creatinine level (every 6 months)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	1 The participating clinical practitioners will be randomized to either "Manual group" or "Guide group". 2 "Diabetes Treatment Guide 2012-2013", published by the Japan Diabetes Society will be provided to the "control group".
Interventions/Control_2	Both "Diabetes Treatment Guide 2012-2013" and "the Standard Diabetes Manual" published by National Center for Global Health and Meidicine be provided to the "Manual group"
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Those who satisfies all the following conditions: 1 Type 2 diabetes mellitus 2 Age between 20 and 75 years 3 Under care by the primary physician for more than 1 year
Key exclusion criteria	None
Target sample size	400

Research contact person
Name of lead principal investigator	Mitsuhiko Noda
Organization	National Center for Global Health and Medicine
Division name	Diabetes and Metabolic Diseases
Address	1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL	03-3202-7181
Email	noda-3im@io.ocn.ne.jp

Public contact
Name of contact person	Mitsuhiko Noda
Organization	National Center for Global Health and Medicine
Division name	Diabetes and Metabolic Diseases
Address	1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	noda-3im@io.ocn.ne.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Health Sciences Research Grant from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	1 Yamaguchi University, Japan 2 Aizawa Hospital, Japan
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 18 Day
Anticipated trial start date	2012 Year 10 Month 27 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 26 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010793