UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047232 |
|---|---|
| Receipt number | R000053867 |
| Scientific Title | Study for Time-in-range prediction from coefficient of variation for each HbA1c |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2022/11/18 09:23:13 |
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Basic information
Public title
Study for Time-in-range prediction from coefficient of variation for each HbA1c
Acronym
Study for Time-in-range prediction from coefficient of variation for each HbA1c
Scientific Title
Study for Time-in-range prediction from coefficient of variation for each HbA1c
Scientific Title:Acronym
Study for Time-in-range prediction from coefficient of variation for each HbA1c
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study regarding formulae which predict TIR>70% from HbA1c and coefficient of variation (CV).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CVs corresponding to HbA1c (M1c is fixed to 0) for optimal predicted value for logistic regression analysis when response variable is TIR>70% and explanatory variable are CV, M1, and M1c.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes on a hospital visit
Key exclusion criteria
Patients who cannot measure glucose levels over 2 weeks.
judged to be unsuitable for participation for medical reasons
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Soichi |
| Middle name | |
| Last name | Takeishi |
Organization
Inuyama Chuo General Hospital
Division name
Diabetes
Zip code
484-8511
Address
6, Futagozuka, Goromaru
TEL
0568628111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | |
| Last name | Takeishi |
Organization
Inuyama Chuo General Hospital
Division name
Diabetes
Zip code
484-8511
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL
0568628111
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Inuyama Chuo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Inuyama Chuo General Hospital
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
Inuyama Chuo General Hospital
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
Tel
0568628111
souichi19811225@yahoo.co.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 | 20 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Outpatients with type 2 diabetes undergo HbA1c testing, wear a flash glucose monitor (FGM: FreeStyle Libre Pro), and do not change diabetic treatments, on a hospital visit. Mean glucose levels, CV, TIR (70-180 mg/dL) are calculated using FGM data over 24 h multiplied by 13 days. Patients with mean glucose levels > 180 mg/dL are excluded from the analysis.
We propose the new metrics of M1 and M1c
Management information
Registered date
| 2022 | Year | 03 | Month | 20 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053867
