UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047337 |
|---|---|
| Receipt number | R000053835 |
| Scientific Title | Relationship between HbA1c and Time in range in the treatment of diabetes |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2024/09/30 11:47:38 |
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Basic information
Public title
Relationship between HbA1c and Time in range in the treatment of diabetes
Acronym
Relationship between HbA1c and Time in range in the treatment of diabetes
Scientific Title
Relationship between HbA1c and Time in range in the treatment of diabetes
Scientific Title:Acronym
Relationship between HbA1c and Time in range in the treatment of diabetes
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the relationship between the conventional index HbA1c and the new index Time in range, and to examine the effectiveness of Continuous Glucose Monitoring (CGM) in the treatment of Japanese diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time in range (%)
Key secondary outcomes
Red blood cell count, white blood cell count, Hemoglobin, hematocrit, platelet count, total protein, albumin, AST, ALT, BUN, creatinine, eGFR, glucose, glycoalbumin, Urine albumin / creatinine ratio, data from a continuous glucose monitoring
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
Diabetic patients using continuous blood glucose monitoring
Key exclusion criteria
1 Patients with mechanical failure of continuous glucose monitoring during the study period
2 Diabetic patients not using continuous glucose monitoring
3 Patient with intolerance of medical reasons by doctor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Aso |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
+81282861111
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshie |
| Middle name | |
| Last name | Iijima |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282861111
Homepage URL
toshie@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel
0282872275
r-kenkyu@dokkyomed.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
| 2022 | Year | 03 | Month | 31 | 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
| 2021 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2022 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053835
