UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042367