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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000034231
Receipt No. R000039019
Scientific Title Seasonal variations in the achievement of guideline targets for HbA1c, blood pressure, and cholesterol among type 2 diabetic patients: A nationwide population-based study
Date of disclosure of the study information 2018/09/21
Last modified on 2018/09/21

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Basic information
Public title Seasonal variations in the achievement of guideline targets for HbA1c, blood pressure, and cholesterol among type 2 diabetic patients: A nationwide population-based study
Acronym ABC study
Scientific Title Seasonal variations in the achievement of guideline targets for HbA1c, blood pressure, and cholesterol among type 2 diabetic patients: A nationwide population-based study
Scientific Title:Acronym ABC study
Region
Japan

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

Objectives
Narrative objectives1 The monthly achievement rates for each value that are required to determine the specific treatment strategy remains unknown.we evaluate, rates of achievement of guideline targets for HbA1c, BP, and low-density lipoprotein (LDL)-cholesterol on a monthly basis in patients with T2DM and explored factors affecting the achievement rates.
Basic objectives2 Others
Basic objectives -Others Find factors related to HbA1c variability.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary objective was to evaluate the all ABC (HbA1c,Blood pressure,LDL-C) achievement rate for each month.
2 years from 2013 to 2014
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 The inclusion criteria were patients whose HbA1c,BP,and LDL-cholesterol were measured 12 or more times during the two-year period between January 2013 and December2014; who were age greater than or equal to 20 years and under 75 years; and who had T2DM diagnosed based on criteria in the Report of the Committee of Japan Diabetes Society on the Classification and Diagnostic Criteria of Diabetes Mellitus.
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 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name masaya sakamoto
Organization Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
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
Middle name
Last name Masaya Sakamoto
Organization Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
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
Address
Tel
Email

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
2018 Year 09 Month 21 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 Main results already published
Date of protocol fixation
2017 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 26 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
2020 Year 03 Month 30 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information Of the 104,601 registered patients in 38 medical clinics, 4,678 were finally included in the analysis.

Management information
Registered date
2018 Year 09 Month 21 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039019

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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