UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052018 |
|---|---|
| Receipt number | R000059379 |
| Scientific Title | Research on Diabetes Remote Consultation Using Microsoft Teams |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2025/02/27 14:10:29 |
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Basic information
Public title
Research on Diabetes Remote Consultation Using Microsoft Teams
Acronym
Misasa study
Scientific Title
Research on Diabetes Remote Consultation Using Microsoft Teams
Scientific Title:Acronym
Misasa study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The maldistribution of doctors has been a problem for some time, and the maldistribution of specialists is also remarkable. Online medical care is one solution to correcting disparities in medical care, but this is a field that the government is focusing on, as the Information and Communications Bureau of the Ministry of Internal Affairs and Communications has released a telemedicine model reference book. However, full-scale online medical consultations are often expensive, and the hurdles to introducing them tend to be high. Therefore, we decided to use Microsoft Teams of Microsoft 365, which supports 3 ministries and 2 guidelines and has low introduction and running costs. Currently, there are no reports of studies examining continuous online diabetes examinations in Japan. Therefore, in this study, we decided to verify the patient's glycemic control and satisfaction by performing remote consultation using Microsoft Teams for diabetic patients who are far away.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction by questionnaire
Key secondary outcomes
Changes in blood glucose level and HbA1c before and after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Okayama University Hospital Diabetes Specialist (hereinafter referred to as A) and Misasa Onsen Hospital physician (hereinafter referred to as B) have announced in advance what treatments (e.g. internal medicines) can be introduced at the outpatient clinic on the day, and then at the next outpatient clinic. Decide which therapy to introduce (eg, insulin therapy). The research subjects who have obtained consent from Party B will be asked to write a questionnaire for the first time, and from the next outpatient consultation will be conducted in the form of D to P with D. Please fill out the questionnaire as shown in the flow chart below. For the presentation of treatment, Party A describes the treatment using a password-protected Word document and uploads it through Teams, and Party B downloads and confirms it. After the medical treatment is completed, B uploads the document to Teams in Word protected with a password, and Party A downloads and confirms what kind of treatment was performed.
If the consent of the research subject and Party B is obtained, the next outpatient will consult in the form of D to P with N (Misasa Onsen Hospital nurse or nutritionist), and in the same procedure, Party A will present a treatment method to Party B. Uploads what kind of treatment was performed after the examination, and Party A downloads and confirms. If the consent of the research subject and Party B cannot be obtained, we will continue to provide consultation in the form of D to P with D.
In addition, questionnaires will be given to the research subjects at the time of consent acquisition, at the time of the first remote consultation, and at the time of the outpatient visit every 3 months.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who are able to obtain written consent from the individual to participate in the research voluntarily with sufficient understanding after receiving sufficient explanation about participating in this research.
2.Patients aged 18 years or older at the time of informed consent
3.Patients with type 2 and type 1 diabetes who go to Misasa Onsen Hospital
4.outpatient
Key exclusion criteria
Patients who are judged to be inappropriate as research subjects by the principal investigator or co-investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Wada |
| Middle name | |
| Last name | Jun |
Organization
Okayama University
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
Okayama University Clinical Research Building 4F, 2-5-1 Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7235
junwada@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Nojima |
| Middle name | |
| Last name | Ichiro |
Organization
Okayama University
Division name
Department of Comprehensive Treatment for Chronic Renal Failure
Zip code
700-8558
Address
Okayama University Clinical Research Building 4F, 2-5-1 Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7235
Homepage URL
pesi2e4f@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Okayama University Ethics Review Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City
Tel
086-235-6938
mae6605@adm.okayama-u.ac.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
| 2023 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059379
