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
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
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)
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
