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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037524
Receipt No. R000042784
Scientific Title Estimated A1c discordance: Should estimated A1c derive from time in range or mean glucose level ?
Date of disclosure of the study information 2019/07/29
Last modified on 2020/01/28

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Basic information
Public title Estimated A1c discordance: Should estimated A1c derive from time in range or mean glucose level ?
Acronym eA1c discordance study
Scientific Title Estimated A1c discordance: Should estimated A1c derive from time in range or mean glucose level ?
Scientific Title:Acronym eA1c discordance study
Region
Japan

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

Objectives
Narrative objectives1 To compare time in range (TIR)-derived estimated A1c (eA1c) [T-eA1c] to mean glucose level (M)-derived eA1c [M-eA1c]
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between T-eA1c - M-eA1c (delta eA1c) and mean glucose level
Key secondary outcomes Relationship between delta eA1c and coefficient of variation
Relationship between delta eA1c and TIR (<70 mg/dL)

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 whose 24-h glucose levels were measured continiuously using CGM.
Key exclusion criteria judged to be unsuitable for participation for medical reasons
Target sample size 150

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
Email 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
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 Inuyama Chuo General Hospital
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
Tel 0568-62-8111
Email 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
2019 Year 07 Month 29 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 119
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
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 04 Month 30 Day
Anticipated trial start date
2019 Year 04 Month 30 Day
Last follow-up date
2019 Year 12 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 (CGM: iPro2) data of 150 patients with type 2 diabetes whose 24-h glucose levels were measured continiuously.

Management information
Registered date
2019 Year 07 Month 29 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042784

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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