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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034425
Receipt No. R000039258
Scientific Title A relationship between glycemic variability and a risk of hypoglycemia in short- and intermediate-term evaluation using continuous glucose monitoring data
Date of disclosure of the study information 2018/10/09
Last modified on 2018/10/09

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Basic information
Public title A relationship between glycemic variability and a risk of hypoglycemia in short- and intermediate-term evaluation using continuous glucose monitoring data
Acronym A relationship between glycemic variability and a risk of hypoglycemia in short- and intermediate-term evaluation
Scientific Title A relationship between glycemic variability and a risk of hypoglycemia in short- and intermediate-term evaluation using continuous glucose monitoring data
Scientific Title:Acronym A relationship between glycemic variability and a risk of hypoglycemia in short- and intermediate-term evaluation
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate a relationship between glycemic variability and a risk of hypoglycemia in short- and intermediate-term evaluation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of prediction ability for low blood glucose index (LBGI)>2.5 or 5.0 for 13 days (from day2 to day14) in the following glycemic variability metrics
Coefficient of variation (CV) (24 hours (day2))
Mean absolute glucose (MAG)/mean glucose level (mean) (24 hours (day2))
Glycemic variability percentage (GVP)/mean (24 hours (day2))
CV (for 13 days (from day2 to day14))
MAG/ mean (for 13 days (from day2 to day14))
GVP/mean (for 13 days (from day2 to day14))
Key secondary outcomes Comparison of prediction ability for low blood glucose index (LBGI)>2.5 or 5.0 for 24 hours (day2) in the following glycemic variability metrics
CV (24 hours (day2))
MAG/mean glucose level (mean) (24 hours (day2))
GVP/mean (24 hours (day2))

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
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute Inuyama Chuo General Hospital
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 09 Day
Last follow-up date
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 240 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
2018 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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