UMIN-CTR Clinical Trial

Basic information
Public title	Survey research for patients with type 2 diabetes
Acronym	Survey research for patients with type 2 diabetes
Scientific Title	Survey research for patients with type 2 diabetes
Scientific Title:Acronym	Survey research for patients with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between consciousness and anxiety about treatment, motivation for treatment and patient background, and glycemic control in older adults with type 2 diabetes.
Basic objectives2	Others
Basic objectives -Others	Fact-finding survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Glycemic control (achieved / unachieved) 2) Awareness of diabetes treatment 3) Satisfaction with diabetes treatment 4) Compliance with drug treatment 5) Motivation for treatment 6) Anxiety about diabetes treatment 7) Flail 8) The potential of sarcopenia 9) Fall 10) Hypoglycemic symptoms 11) Cognitive function (memory, orientation), instrumental ADL and basic ADL
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who are over 20 years old and have been diagnosed with type 2 diabetes (2) Patients who are currently visiting the hospital and receiving drug treatment with diabetic drugs (3) Patients whose HbA1c level was measured within 6 months before the start of the research (4) Patients who have given their voluntary consent to participate in the research
Key exclusion criteria	(1) Patients who cannot confirm the use of diabetes medicine (2) Patients whose HbA1c level cannot be confirmed within 6 months before the start of the research
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Suzuki
Organization	Tokyo Medical University
Division name	Department of Diabetes, Metabolism & Endocrinology
Zip code	160-0023
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Email	ryosuzuki-tky@umin.ac.jp

Public contact
Name of contact person	1st name Inquiry counter Middle name Last name Seikatu Kojo WEB
Organization	3H Clinical Trial Inc.
Division name	Inquiry counter of Seikatu Kojo WEB
Zip code	171-0022
Address	Ikebukuro YS Bldg.2F, 1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
TEL	0120-963-787
Homepage URL
Email	info@c-trial.com

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical University Institutional Review Board
Address	6-7-1,Nishi-shinjuku,Shinjuku,Tokyo
Tel	03-3342-6111
Email	IRB@tokyo-med.ac.jp

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	2020 Year 09 Month 07 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	2020 Year 03 Month 10 Day
Date of IRB	2020 Year 08 Month 05 Day
Anticipated trial start date	2020 Year 09 Month 07 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We investigate the relationships between glycemic control and patient interest in diabetes management, motivation, anxiety for diabetes treatment, patient background in older adults with type 2 diabetes.

Management information
Registered date	2020 Year 09 Month 04 Day
Last modified on	2020 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047587