UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037177
Receipt number R000042367
Scientific Title Appropriate glycemic goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes.
Date of disclosure of the study information 2019/08/01
Last modified on 2020/12/27 18:04:58

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Basic information

Public title

Appropriate glycemic goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes.

Acronym

Appropriate glycemic goals in elderly patients with diabetes

Scientific Title

Appropriate glycemic goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes.

Scientific Title:Acronym

Appropriate glycemic goals in elderly patients with diabetes

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of our study is to investigate the agreement between measured HbA1c and HbA1c goals based on the physical condition evaluated by the Dementia Assessment Sheet for Community-based Integrated Care System 8-items (DASC-8) in elderly patients with diabetes.

Basic objectives2

Others

Basic objectives -Others

The aim of our study is to evaluate the association between the agreement for glycemic goals based on DASC-8 and diabetes-related complications in elderly patients with diabetes.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Agreement between HbA1c goals based on DASC-8 and measured HbA1c

Key secondary outcomes

The association between agreement for HbA1c goals based on DASC-8 and clinical characteristics, glucose-related parameters or insulin secretion

The association between the physical condition evaluated by DASC-8 and diabetes-related complications


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

1) 65 years of age or more
2) Patients with diabetes
3) Written informed consent

Key exclusion criteria

1) Patients who have history of diabetic ketoacidosis, or diabetic coma in the past 6 months
2) Patients with serious infectious disease, before operation, serious trauma in the past 6 months
3) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Akinobu
Middle name
Last name Nakamura

Organization

Hokkaido University Hospital

Division name

Internal Medicine II

Zip code

060-8638

Address

North 14, West 5, Kita-ku, Sapporo, Hokkaido

TEL

011-706-5915

Email

akinbo@tim.hi-ho.ne.jp


Public contact

Name of contact person

1st name Akinobu
Middle name
Last name Nakamura

Organization

Hokkaido University Hospital

Division name

Internal Medicine II

Zip code

060-8638

Address

North 14, West 5, Kita-ku, Sapporo, Hokkaido

TEL

011-706-5915

Homepage URL


Email

akinbo@tim.hi-ho.ne.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University Hospital

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

Hokkaido University Hospital Clinical Research and Medical Innovation Center

Address

North 14, West 5, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7061

Email

none@none


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

北海道大学病院(北海道)
NTT東日本札幌病院(北海道)
萬田記念病院(北海道)
帯広厚生病院(北海道)
釧路赤十字病院(北海道)
苫小牧市立病院(北海道)
北海道中央労災病院(北海道)
沖医院(北海道)
栗原内科(北海道)
さっぽろ糖尿病・甲状腺クリニック(北海道)


Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 01 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

2019 Year 05 Month 29 Day

Date of IRB

2019 Year 09 Month 10 Day

Anticipated trial start date

2019 Year 09 Month 10 Day

Last follow-up date

2020 Year 07 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is as observational study.


Management information

Registered date

2019 Year 06 Month 26 Day

Last modified on

2020 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name