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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044003
Receipt No. R000050027
Scientific Title Establishment of a new glycemic control metric aiming at telemedicine for diabetes treatment
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/21

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Basic information
Public title Establishment of a new glycemic control metric aiming at telemedicine for diabetes treatment
Acronym Examination of the correlation between estimated HbA1c by CGM and measured HbA1c
Scientific Title Establishment of a new glycemic control metric aiming at telemedicine for diabetes treatment
Scientific Title:Acronym Examination of the correlation between estimated HbA1c by CGM and measured HbA1c
Region
Japan

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

Objectives
Narrative objectives1 Currently, HbA1c is often used to grasp the control status of diabetes. HbA1c has also been used as an index of glycemic control in past clinical studies. Since the value of HbA1c can be obtained by analyzing the components in the blood, it is essential to visit a medical institution and collect blood. Therefore, it is essential to visit a medical institution in order to obtain good glycemic control. This is a barrier to telemedicine treatment of diabetes.
In recent years, a device that continuously monitors the subcutaneous glucose concentration has become available in clinical practice, and it has become possible to continuously grasp the blood glucose level. The continuous glucose monitor (CGM) allows the patient to attach a sensor and collect data using a dedicated device. The data is digitized, visualized by using dedicated analysis software, and used for medical treatment. That is, the patient's biological information can be transmitted and received as electronic data, which is expected to lead to future development in telemedicine. Furthermore, the estimated HbA1c can be calculated using the results of these devices. However, it is often experienced that the estimated HbA1c does not always match the actual HbA1c.
The purpose of this study is to examine the correlation between the estimated HbA1c calculated by CGM and the measured HbA1c in actual clinical practice. If there is a shift, the next purpose is to clarify the factors that influence the shift.
Basic objectives2 Others
Basic objectives -Others Elucidation of factors affecting data
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between estimated HbA1c and measured HbA1c
Key secondary outcomes (1) Correlation between estimated HbA1c and measured HbA1c by disease type and age
(2) Identification of factors that influence the correlation between estimated HbA1c and measured HbA1c

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Diabetes mellitus
(2)Patients who have used CGM for the past 4 months or more
Key exclusion criteria (1)Patients who don't agree to join the examination
(2)Determined to be ineligible by the physician in charge for any other reason
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Jin
Middle name
Last name Kumagai
Organization Chiba University
Division name Department of Endocrinology, Hematology, and Gerontology
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-226-2089
Email kumaj@chiba-u.jp

Public contact
Name of contact person
1st name Jin
Middle name
Last name Kumagai
Organization Chiba University
Division name Department of Endocrinology, Hematology, and Gerontology
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-226-2089
Homepage URL
Email kumaj@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research ethics committee of the graduate school of medicine, Chiba university
Address 1-8-1 Inohana, Chuo-ku, Chiba
Tel 043-222-7171(5077)
Email igaku-rinri@office.chiba-u.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
2021 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 03 Day
Date of IRB
2020 Year 11 Month 25 Day
Anticipated trial start date
2021 Year 04 Month 22 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1)Retrospective cohort study
(2) Observation items / inspection items
Gender, age, height, weight, current medical history, medical history, family history, life history, complications
Blood glucose, HbA1c, glycoalbumin, blood count, biochemical test (albumin, liver function, renal function, blood C-peptide, etc.), urinary sugar
Treatment (oral, insulin, GLP-1 receptor agonist), CGM recording

Management information
Registered date
2021 Year 04 Month 21 Day
Last modified on
2021 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050027

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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