UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041686
Receipt No. R000047587
Scientific Title Survey research for patients with type 2 diabetes
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.