UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033413
Receipt number 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 13:31:06

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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 or person

Institute

Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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