UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047257 |
|---|---|
| Receipt number | R000053898 |
| Scientific Title | AI Hospital program study on operational verification of diabetes diagnostic support service system |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2022/06/01 16:45:30 |
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Basic information
Public title
AI Hospital program study on operational verification of diabetes diagnostic support service system
Acronym
AI Hospital program study on operational verification of diabetes diagnostic support service system
Scientific Title
AI Hospital program study on operational verification of diabetes diagnostic support service system
Scientific Title:Acronym
AI Hospital program study on operational verification of diabetes diagnostic support service system
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Try out the 'diabetes diagnostic support service system' applications in order to verify operations of the system in a practical use stage, in light of interactions between dedicated devices, the software and AI as well as usability for examinees
Basic objectives2
Others
Basic objectives -Others
operation check
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Weight, blood pressure value, blood glucose level, steps, sleep duration, and meal of examinees (data collected via the applications)
-Applications' problems and any harmful events therefrom caused to suffer examinees
-Questionnaires answered by examinees
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Help improve lifestyle by using the applications to receive input data and return feedbacks
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. Outpatients that consented at an age from Over 20 years old (regardless of gender)
2. Patients of Type 2 Diabetes as diagnosed (HbA1c6.5% or more)
3. Patients capable of taking photos and emailing via iPhone (of 14 or more iOS)
4. Patients scheduled to receive medical examinations in the period from the study initiation date to April 25, 2022.
Key exclusion criteria
Patients that indicated rejection to participating in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Hatori |
Organization
Hatori Clinic Medical Corporation
Division name
Internal medicine
Zip code
212-0058
Address
1-8-33 Kashimada, Saiwai-ku, Kwasaki, Kanagawa
TEL
044-522-0033
yutaka@hatori.or.jp
Public contact
Name of contact person
| 1st name | Shungo |
| Middle name | |
| Last name | Oki |
Organization
Nihon Unisys Corporation
Division name
Social&Public Business Services2
Zip code
135-8560
Address
1-1-1 Toyosu, Koto-ku, Tokyo
TEL
050-3132-9113
Homepage URL
shungo.oki@unisys.co.jp
Sponsor or person
Institute
Hatori Clinic Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
National Institutes of Biomedical Innovation, Health and Nutrition.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Trials, Japan Medical Association
Address
2-28-8 Hon-komagome, Bunkyou-ku, Tokyo
Tel
03-5319-3802
rinri@jmacct.med.or.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
| 2022 | Year | 03 | Month | 23 | 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
8
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
| 2022 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053898
