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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037177
Receipt No. 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 2019/09/30

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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
Institute Hokkaido University Hospital
Institute
Department

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 Open public recruiting
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 12 Month 31 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
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.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


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