UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047233 |
|---|---|
| Receipt number | R000053869 |
| Scientific Title | What affects the minimal duration needed to estimate time in range? |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2022/11/18 09:23:38 |
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Basic information
Public title
What affects the minimal duration needed to estimate time in range?
Acronym
What affects the minimal duration needed to estimate time in range?
Scientific Title
What affects the minimal duration needed to estimate time in range?
Scientific Title:Acronym
What affects the minimal duration needed to estimate time in range?
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation regarding relationship between variability of 24h-TIR over target duration and minimum duration needed to estimate time-in-range (MD) over target duration.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between SD of 24h-TIR over selected duration and percentage of MD over the selected duration. (n = 31)
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
Patients with type 2 diabetes visiting our hospital and not using isCGM.
Key exclusion criteria
Cases where both data over more than 9.6h/day for each day and data more than 16.8 h/day on average of 14 days, per one sensor, cannot be obtained.
judged to be unsuitable for participation for medical reasons
Target sample size
70
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, Japan.
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 | 11 | 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 | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with type 2 diabetes visiting our hospital wear an isCGM (FreeStyle Libre) afresh over 90 days. Patients do not change diabetic treatments for 12 weeks after start of isCGM. We select the isCGM data for 60 days from those over 90 days 31 times while shifting the select start day one by one from day 1 (1-60, 2-61...30-81, 31-90).
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=R000053869
