UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the usefulness of "glycemic control target of elderly diabetic patients" for the prevention of drug induced severe hypoglycemia
Title of the study (Brief title)	EUCLID
Region	Japan

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

Objectives
Narrative objectives1	In May 2016 "Glycemic control target of elderly diabetes mellitus" was announced by the Joint Committee of the Japan Diabetes Society and the Japan Gerontological Society for improving treatment of the elderly diabetes. We evaluate the adequacy of this target from elderly diabetes cases who were hospitalized with hypoglycemia and had to be hospitalized.
Basic objectives2	Others
Basic objectives -Others	Many diabetic drugs are renal excretion metabolism. We will examine the relationship between renal dysfunction and hypoglycemia.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c at hospitalization
Key secondary outcomes	eGFR at hospitalization

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases of an elderly diabetes patient aged 65 years or older who was hospitalized with hypoglycemic ambulance from January 1, 2008 to April 30, 2014.
Key exclusion criteria	Patients under the age of 65 including minors. Cases in which dementia, ADL decline, complication of infection, and malignant tumor are confirmed from the medical record.
Target sample size	150

Research contact person
Name of lead principal investigator	Masao Toyoda
Organization	Tokai University School of Medicine
Division name	Division of Nephrology, Endocrinology and Metabolism
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL	0463-93-1121
Email	m-toyoda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Kanori Iwamatsu
Organization	Tokai University School of Medicine
Division name	Division of Nephrology, Endocrinology and Metabolism
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL	0463-93-1121
Homepage URL
Email	k-iwamtsu@tsc.u-tokai.ac.jp

Sponsor
Institute	Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2018 Year 07 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 27 Day
Anticipated trial start date	2017 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	No intervention, retrospective obs ervation study.

Management information
Registered date	2018 Year 07 Month 17 Day
Last modified on	2018 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038096