UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034425 |
|---|---|
| Receipt number | R000039258 |
| Scientific Title | How are relationships of hypoglycaemia over 2 weeks to glycaemic variability different every measurement duration for glycaemic variability? |
| Date of disclosure of the study information | 2018/10/09 |
| Last modified on | 2020/02/07 08:34:56 |
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Basic information
Public title
How are relationships of hypoglycaemia over 2 weeks to glycaemic variability different every measurement duration for glycaemic variability?
Acronym
How are relationships of hypoglycaemia over 2 weeks to glycaemic variability different every measurement duration for glycaemic variability?
Scientific Title
How are relationships of hypoglycaemia over 2 weeks to glycaemic variability different every measurement duration for glycaemic variability?
Scientific Title:Acronym
How are relationships of hypoglycaemia over 2 weeks to glycaemic variability different every measurement duration for glycaemic variability?
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated how relationships of hypoglycaemia over 2 weeks to GV are different every measurement duration for GV.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We analysed associations of GV derived from extracted durations to percentage of time in hypoglycaemic range (< 70 mg/dL) derived from total duration [TIR<70 (13)].
Key secondary outcomes
We analysed associations of GV derived from extracted durations to percentage of time in hypoglycaemic range (< 70 mg/dL) derived from extracted durations.
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 whose 24-h glucose levels were measured continiuously for 13 days using continuous glucose monitoring (FreeStyle Libre Pro).
Key exclusion criteria
judged to be unsuitable for participation for medical reasons
Target sample size
240
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
0568-62-8111
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
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, Japan.
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
| 2018 | Year | 10 | Month | 09 | 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
168
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
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional study. We investigate the continuous glucose monitor (FreeStyle Libre Pro) data of patients with type 2 diabetes whose 24-h glucose levels were measured continiuously for 13 days. We analyse the continuous glucose monitor data from 00:00 (day 2) to 24:00 (day 14).
Management information
Registered date
| 2018 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039258
