UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045290 |
|---|---|
| Receipt number | R000051730 |
| Scientific Title | The distribution of HbA1c corresponding to time in range and the origin of distribution |
| Date of disclosure of the study information | 2021/08/28 |
| Last modified on | 2022/11/18 09:22:48 |
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Basic information
Public title
The distribution of HbA1c corresponding to time in range and the origin of distribution
Acronym
The distribution of HbA1c corresponding to time in range and the origin of distribution
Scientific Title
The distribution of HbA1c corresponding to time in range and the origin of distribution
Scientific Title:Acronym
The distribution of HbA1c corresponding to time in range and the origin of distribution
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 the effect of differences in distribution between HbA1c and TIR on interval estimation and interval prediction for regression analysis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Position of center of curves for 95% confidence intervals of predicted HbA1c derived from TIR (C95%CIcurves) for regression analysis.
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, Inuyama-city, Aichi
TEL
0568-62-8111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | Takeishi |
| Last name | Takeishi |
Organization
Inuyama Chuo General Hospital
Division name
Diabetes
Zip code
484-8511
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi
TEL
0568-62-8111
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
Tel
0568-62-8111
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
| 2021 | Year | 08 | Month | 28 | 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 | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2021 | 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. TIR and mean glucose levels (Mean) are calculated using FGM data over 24 h multiplied by 13 days. We select 2 patterns of patients whose HbA1c values are distributed equally from registered patients. Pattern 1 is selected for achieving the following contents: Patients whose HbA1c is low have low TIR; The ratio of time below range (<70 mg/dL) to time above range (>180 mg/dL) (TBR<70/TAR>180) negatively correlate to HbA1c. Pattern 2 is selected for achieving the following contents: TBR<70/TAR>180 does not correlate to HbA1c.
Management information
Registered date
| 2021 | Year | 08 | Month | 28 | 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=R000051730
