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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035098
Receipt No. R000040008
Official scientific title of the study Comparison of real-time vs. professional continuous glucose monitoring related to calibration
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/01

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Basic information
Official scientific title of the study Comparison of real-time vs. professional continuous glucose monitoring related to calibration
Title of the study (Brief title) Comparison of real-time vs. professional continuous glucose monitoring related to calibration
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 accuracy of real-time and professional continuous glucose monitoring (CGM) by evaluating sensor glucose variability in pre and post of blood glucose levels used to calibrate in real-time and professional CGM
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CaI (original index) of each 160 pair in real-time and professional CGM
Key secondary outcomes Relationship between CaI A (original index) and CaI B (original index) in real-time and professional CGM

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 who wear Real-time CGM or professional CGM and whose preprandial and bedtime glucose levels from day 2 to day 5 are evaluated.
Key exclusion criteria judged to be unsuitable for participation for medical reasons
Target sample size 20

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 12 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 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 each 160 pair of blood glucose levels used to calibrate and sensor glucose levels in pre and post of those in 10 patients on real-time CGM and in 10 patients on professional CGM. We evaluate preprandial and bedtime glucose levels from days 2 to 5.

Management information
Registered date
2018 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040008

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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