UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044003
Receipt number 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 2023/10/23 10:11:45

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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 or person

Institute

Chiba University Hospital

Institute

Department

Personal name



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

87

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

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

2023 Year 10 Month 23 Day



Link to view the page

Value
https://center6.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