UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041686 |
|---|---|
| Receipt number | 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 20:27:43 |
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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
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
info@c-trial.com
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047587
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
