UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052567 |
|---|---|
| Receipt number | R000059982 |
| Scientific Title | Validation Study on Diagnosis Codes for Diabetes-Related Events in Receipt Data with EMR Data Diagnosis Codes as Gold Standard |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2023/10/21 10:40:38 |
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Basic information
Public title
Validation Study on Diagnosis Codes for Diabetes-Related Events in Receipt Data with EMR Data Diagnosis Codes as Gold Standard
Acronym
Validation Study on Diagnosis Codes for Diabetes-Related Events in Receipt Data with EMR Data Diagnosis Codes as Gold Standard
Scientific Title
Validation Study on Diagnosis Codes for Diabetes-Related Events in Receipt Data with EMR Data Diagnosis Codes as Gold Standard
Scientific Title:Acronym
Validation Study on Diagnosis Codes for Diabetes-Related Events in Receipt Data with EMR Data Diagnosis Codes as Gold Standard
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the validity of diagnostic algorithms for diabetes-related events (hypoglycemia, diabetic ketoacidosis, rhabdomyolysis, interstitial pneumonia, acute pancreatitis)
Basic objectives2
Others
Basic objectives -Others
Evaluate the validity of diagnostic algorithms for diabetes-related events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the validity of diagnostic algorithms for diabetes-related events (Evaluate by the following indicators)
Positive Predictive Value (PPV)
Sensitivity (SN)
Specificity (SP)
Negative Predictive Value (NPV)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study is a database study using the Real World Data, Co., Ltd.'s database.
Of the above database, patients with a first confirmed diagnosis of diabetes (ICD-10: E10-E14) after April 2014 will be included.
Definition of first confirmed diagnosis:
No confirmed diagnosis of diabetes in the data period prior to the earliest confirmed diagnosis of diabetes after April 2014 and some medical record more than 180 days prior to that confirmed diagnosis of diabetes.
Key exclusion criteria
No set
Target sample size
371548
Research contact person
Name of lead principal investigator
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Biostatistics
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Biostatistics
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7659
Homepage URL
yamaguchi@med.tohoku.ac.jp
Sponsor or person
Institute
EPS Corporation
Institute
Department
Personal name
Funding Source
Organization
EPS Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 10 | Month | 23 | 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
371548
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
| 2023 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the validity of diagnostic algorithms for diabetes-related events
Management information
Registered date
| 2023 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059982
