UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012625 |
|---|---|
| Receipt number | R000014046 |
| Scientific Title | Development and Proof of the telemedicine system for the medical care of diabetic patients using information technology in Saitama Area |
| Date of disclosure of the study information | 2013/12/20 |
| Last modified on | 2020/12/24 11:32:42 |
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Basic information
Public title
Development and Proof of the telemedicine system for the medical care of diabetic patients using information technology in Saitama Area
Acronym
iDEM-saitama
Scientific Title
Development and Proof of the telemedicine system for the medical care of diabetic patients using information technology in Saitama Area
Scientific Title:Acronym
iDEM-saitama
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to be described
Basic objectives2
Others
Basic objectives -Others
to be described
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
to be described
Key secondary outcomes
to be described
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
IT
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
DM
Key exclusion criteria
insulin use
SMBG use
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
3508550
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
049-228-3564
matsudam-ind@umn.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
3508550
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
049-228-3564
Homepage URL
https://telemed.jp
idem@glucose-clamp.com
Sponsor or person
Institute
Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
IRB,Saitama Medical Center, Saitama Medical Univ.
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken, Japan
Tel
0492283400
http://www.kawagoe.saitama-med.ac.jp/chiken/hec/
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
| 2013 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
https://telemed.jp/
Publication of results
Partially published
Result
URL related to results and publications
https://telemed.jp/
Number of participants that the trial has enrolled
10
Results
Urine examination under telemedicine in diabetic patients.
Among 10 patients enrolled, one dropped out, and six patients agreed urine examination. The results of urine examination may be reliable except for one unreliable report that sent examination of a wife of a patient.
It may be possible to carry out this kind of telemedicine in the treatment of diabetic patients, but the reliability of transmitted data should be well examined.
Results date posted
| 2020 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2014 | Year | 05 | Month | 23 | Day |
Baseline Characteristics
n=10(M/F=10/0 (urine 6), age 61.4 plus minus 11.2y.o., average BMI 26.6, average duration of diabetes: 3.4years.
Participant flow
Subjects were recruited from the out-patients clinic of Saitama medical Center, Saitama Mddical University in Kawagoe-city.
Urine exam. was performed using pictures sent through WEB. Pictures of urine sticks were taken with standard panel that can be compared.
Adverse events
none
Outcome measures
Accuracy examination of telemedicine was perfect, except for a pseudo sample. We conducted the study through WEB site.
All subjects resulted better HbA1c compared with HbA1c before.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014046
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/06/24 | 870_IDEM_PLAN.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/06/24 | iDEM_SMC.txt |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/06/24 | 20150523_Urnie_iDEM.ppt |
Single case data URL
Value
https://center6.umin.ac.jp/ice/14046
