UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051545 |
|---|---|
| Receipt number | R000058816 |
| Scientific Title | Establishment of Telemedicine Infrastructure for Prevention of Severe Diabetes in Goto City Mobile Clinic |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2025/04/17 17:31:59 |
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Basic information
Public title
Establishment of Telemedicine Infrastructure for Prevention of Severe Diabetes in Goto City Mobile Clinic
Acronym
Establishment of Telemedicine Infrastructure for Prevention of Severe Diabetes in Goto City Mobile Clinic
Scientific Title
Establishment of Telemedicine Infrastructure for Prevention of Severe Diabetes in Goto City Mobile Clinic
Scientific Title:Acronym
Establishment of Telemedicine Infrastructure for Prevention of Severe Diabetes in Goto City Mobile Clinic
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide online specialized diabetes care, nutritional guidance, and medication counseling to diabetes patients residing in remote areas using a dedicated vehicle, and to explore its effectiveness and challenges.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c data changes
Key secondary outcomes
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
| Medicine | Other |
Interventions/Control_1
Providing specialized diabetes care, nutritional guidance, and medication guidance remotely using a dedicated vehicle
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are currently attending Goto Central Hospital or a clinic in Goto City and meet the diagnosis of diabetes (including those already under diabetes treatment).
2) Age: Patients whose age is 20 years or older at the time of consenting to the study.
3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding of the subject's condition.
Key exclusion criteria
(1) Patients who are scheduled for an MRI scan and for whom the use of FGM is contraindicated.
(2) Patients with a pacemaker, for whom the use of FGM is contraindicated.
(3) Patients who are deemed inappropriate as research subjects by the investigators, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Maeda |
Organization
Nagasaki University
Division name
Department of Island and Community Medicine, Graduate School of Biomedical Sciences
Zip code
853-8691
Address
205, Yoshikugi-cho, Goto-shi, Nagasaki, Japan
TEL
0959-74-2673
tmaeda@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Maeda |
Organization
Nagasaki University
Division name
Department of Island and Community Medicine, Graduate School of Biomedical Sciences
Zip code
853-8691
Address
205, Yoshikugi-cho, Goto-shi, Nagasaki, Japan
TEL
0959-74-2673
Homepage URL
tmaeda@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Graduate School of Biomedical Sciences Administration Department, Nagasaki University
Address
12-4, 1 chome, Sakamoto, Nagasaki-shi, Nagasaki, Japan
Tel
095-819-7195
gakujutu_gakuji@ml.nagasaki-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 | 07 | Month | 10 | 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
9
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2025 | 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 | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058816
