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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033413
Receipt No. R000038096
Scientific Title Evaluation of the usefulness of "glycemic control target of elderly diabetic patients" for the prevention of drug induced severe hypoglycemia
Date of disclosure of the study information 2018/07/17
Last modified on 2018/07/17

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Basic information
Public title Evaluation of the usefulness of "glycemic control target of elderly diabetic patients" for the prevention of drug induced severe hypoglycemia
Acronym EUCLID
Scientific Title Evaluation of the usefulness of "glycemic control target of elderly diabetic patients" for the prevention of drug induced severe hypoglycemia
Scientific Title:Acronym 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
1st name
Middle name
Last name Masao Toyoda
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
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
1st name
Middle name
Last name Kanori Iwamatsu
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 09 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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