UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052915 |
|---|---|
| Receipt number | R000060376 |
| Scientific Title | Discrepancies Between Patient-Set HbA1c Targets and Physician-Defined Treatment HbA1c Goals among Japanese diabetes patients |
| Date of disclosure of the study information | 2023/11/30 |
| Last modified on | 2023/11/27 15:27:43 |
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Basic information
Public title
Discrepancies Between Patient-Set HbA1c Targets and Physician-Defined Treatment HbA1c Goals among Japanese diabetes patients
Acronym
Discrepancies Between Patient-Set HbA1c Targets and Physician-Defined Treatment HbA1c Goals among Japanese diabetes patients
Scientific Title
Discrepancies Between Patient-Set HbA1c Targets and Physician-Defined Treatment HbA1c Goals among Japanese diabetes patients
Scientific Title:Acronym
Discrepancies Between Patient-Set HbA1c Targets and Physician-Defined Treatment HbA1c Goals among Japanese diabetes patients
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore whether there exists a certain number of patients with disparities among the physician's envisioned HbA1c target for diabetes treatment, the patient's self-set HbA1c goal, and the actual HbA1c levels.
Basic objectives2
Others
Basic objectives -Others
Factors Contributing to Discrepancies Between Physician-Set and Patient-Set Target Values
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the patient's self-set HbA1c goal
Key secondary outcomes
the actual HbA1c levels
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese Diabetes Patients Willing to Participate in Research
Key exclusion criteria
patients without diabetes.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Onishi |
Organization
The Institute of Medical Science, Asahi Life Foundation
Division name
Division of Diabetes and Metabolism
Zip code
103-0002
Address
2-2-6 Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan
TEL
03-3639-5501
y-ohnishi@asahi-life.or.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Onishi |
Organization
The Institute of Medical Science, Asahi Life Foundation
Division name
Division of Diabetes and Metabolism
Zip code
103-0002
Address
2-2-6 Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan
TEL
03-3639-5501
Homepage URL
y-ohnishi@asahi-life.or.jp
Sponsor or person
Institute
The Institute of Medical Science, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
The Institute of Medical Science, Asahi Life Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institute of Medical Science, Asahi Life Foundation
Address
2-2-6 Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan
Tel
0336395501
y-ohnishi@asahi-life.or.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 | 11 | Month | 30 | 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
2000
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 | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collected data
Medical History and General Physical Examination:
Patient ID
Age
Gender
Height
Weight
BMI
Blood pressure
Treatment details and prescription history
Duration of diabetes
Family history of diabetes
Blood Tests:
Values and dates for each test
HbA1c
Blood glucose
Blood glucose measurement timing (postprandial hours, fasting)
C-peptide
Blood count
AST (Aspartate Aminotransferase)
ALT (Alanine Aminotransferase)
gamma GTP (Gamma-Glutamyl Transferase)
BUN (Blood Urea Nitrogen)
Cre (Creatinine)
eGFR (Estimated Glomerular Filtration Rate)
T-Cho (Total Cholesterol)
LDL-C (Low-Density Lipoprotein Cholesterol)
HDL-C (High-Density Lipoprotein Cholesterol)
TG (Triglycerides)
Uric acid
CRP (C-Reactive Protein)
Urinalysis:
Values and dates for each test
Urine protein
Urine albumin
Urinary creatinine
Two Types of Questionnaires:
Patient Questionnaire:
Patient ID
Name
Date of birth
Self-set target HbA1c value
Physician Questionnaire:
Diabetes type
Physician's target HbA1c value
The investigation involves examining the patient's self-set target HbA1c value, the physician's treatment target HbA1c value, and the actual measured HbA1c value on the date of the questionnaire. Statistical analysis will be conducted to explore the characteristics of this clinical profile.
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060376
| Research Plan | |
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| 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 |
