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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032899
Receipt No. R000037513
Official scientific title of the study A novel metric for evaluating daily variance from continuous glucose monitor data
Date of disclosure of the study information 2018/06/07
Last modified on 2018/07/31

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Basic information
Official scientific title of the study A novel metric for evaluating daily variance from continuous glucose monitor data
Title of the study (Brief title) A novel metric for evaluating daily variance
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 novel metric for evaluating daily variance from continuous glucose monitor data
Basic objectives2 Others
Basic objectives -Others development of glycemic variability metric
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlations of all combination of 2 indexes selected from the following 9 indexes
MODMD (mean of daily multiple difference) (original index) (for 13 days)
MODCV (mean of daily coefficient of variation) (original index) (for 13 days)
Mean absolute glucose (MAG) (for 13 days)
Glycemic variability percentage (GVP) (for 13 days)
Mean glucose level (for 13 days)
Standard deviation (SD) (for 13 days)
Coefficient of variation (CV) (for 13 days)
low blood glucose index (LBGI) (for 13 days)
high blood glucose index (HBGI) (for 13 days)
Key secondary outcomes Determination of cut-off values, which had the highest prediction ability, for both GVP <20% and CV <36% in MODMD and for both LBGI <2.5 and CV <36% in MODCV

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 104 patients with type 2 diabetes whose 24-h glucose levels were measured continiuously for 13 days
Key exclusion criteria judged to be unsuitable for participation for medical reasons
Target sample size 104

Research contact person
Name of lead principal investigator Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
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)

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 06 Month 07 Day

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 07 Day
Anticipated trial start date
2018 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This is a cross-sectional study. We investigate the continuous glucose monitor (FreeStyle Libre Pro) data of 104 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), namely, for 24-h times 13 days.

Management information
Registered date
2018 Year 06 Month 07 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037513

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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