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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037179
Receipt No. R000042371
Scientific Title Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Date of disclosure of the study information 2019/06/27
Last modified on 2019/06/26

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Basic information
Public title Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Acronym Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Scientific Title Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Scientific Title:Acronym Contributing factors associated with visit-to-visit variability of HbA1c and blood pressure in type 2 diabetic patients: a real world analysis (JDDM)
Region
Japan

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

Objectives
Narrative objectives1 The primary study objective was evaluation of contributing factors of VVV of HbA1c and SBP.
Basic objectives2 Others
Basic objectives -Others Secondary objectives included the evaluation of monthly mean HbA1c for each mean HbA1c groups; multiple comparison of median VVV of HbA1c among the mean HbA1c groups; monthly SBP for each mean SBP groups; and multiple comparison of median VVV of SBP among the mean SBP groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary study objective was evaluation of contributing factors of VVV of HbA1c and SBP.
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
75 years-old >
Gender Male and Female
Key inclusion criteria This study analyzed data from ABC trial (Diabetes Care. 2019) in order to explore contributing factors that increase VVV of HbA1c and BP. The ABC trial initially analyzed data on 104,601 persons. In this study, a total of 15,927 patients with T2DM whose HbA1c and BP were measured more than 12 times during the two years (January 2013 to December 2014) were enrolled.
Key exclusion criteria Exclusion criteria were not visiting the clinic regularly, visit intervals ofgreater than or equal to 2 months; type 1 diabetes mellitus; hemodialysis for end-stage renal failure; and information not available on anti-diabetic drugs, anti-hypertensive agents, lipid-lowering agents, antiplatelet drug use, current smoking status, alcohol drinking status, family history of diabetes, or diabetes duration
Target sample size 17000

Research contact person
Name of lead principal investigator
1st name Masaya
Middle name
Last name Sakamoto
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code 105-8471
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email m-sakamoto@umin.ac.jp

Public contact
Name of contact person
1st name Masaya
Middle name
Last name Sakamoto
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code 105-8471
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email m-sakamoto@umin.ac.jp

Sponsor
Institute Japan Diabetes Clinical Data Management (JDDM)
Institute
Department

Funding Source
Organization Tsuruoka Kyoritsu Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Jikei University School of Medicine
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
Tel 03-3433-1111
Email m-sakamoto@umin.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 JDDM2017-6
Org. issuing International ID_1 Japan Diabetes Clinical Data Management (JDDM)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 27 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 17000
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 No longer recruiting
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2017 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 02 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 06 Month 26 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042371

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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