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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034506
Receipt No. R000039343
Scientific Title Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Date of disclosure of the study information 2018/10/15
Last modified on 2018/10/15

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Basic information
Public title Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Acronym Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Scientific Title Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Scientific Title:Acronym Evaluation of the psychological burden for the medical treatment on patients with type 2 diabetes measured by Diabetic Treatment Burden Questionnaire (DTBQ).
Region
Japan

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

Objectives
Narrative objectives1 To compare psychological burden between once-daily injection and once-weekly injection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diabetes Treatment Burden Questionnaire (DTBQ)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 once-weekly injection
Interventions/Control_2 once-daily injection
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
99 years-old >=
Gender Male and Female
Key inclusion criteria HbA1c>=7.0% and <10.0%
Have 2 or more oral anti-diabetics
Have never been treated with insulin and GLP-1 receptor agonist
Have stable regimen of anti-diabetics for more than 12 weeks
Key exclusion criteria Type 1 diabetes
patient who are not competent
Patient who are inappropriate judged by investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nozaki Aya
Organization Nagasaki Harbor Medical Center
Division name Diabetes and Endocrinology
Zip code
Address 6-39, shinchi-machi, Nagasaki, Nagasaki
TEL 095-822-3251
Email aya_s0714@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nozaki Aya
Organization Nagasaki Harbor Medical Center
Division name Diabetes and Endocrinology
Zip code
Address 6-39, shinchi-machi, Nagasaki, Nagasaki
TEL 095-822-3251
Homepage URL
Email aya_s0714@yahoo.co.jp

Sponsor
Institute Nagasaki Harbor Medical Center
Institute
Department

Funding Source
Organization Nagasaki Harbor Medical Center
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
Address
Tel
Email

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 長崎みなとメディカルセンター

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 15 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
2018 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039343

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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