UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037736 |
|---|---|
| Receipt number | R000043040 |
| Scientific Title | Study of remote screening of diabetic retinopathy for diabetic patients in cooperation with internal medicine |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2021/08/21 19:46:01 |
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Basic information
Public title
Study of remote screening of diabetic
retinopathy for diabetic patients in
cooperation with internal medicine
Acronym
Remote screening of diabetic retinopathy
Scientific Title
Study of remote screening of diabetic
retinopathy for diabetic patients in
cooperation with internal medicine
Scientific Title:Acronym
Remote screening of diabetic retinopathy
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When a diabetic patient visits a clinic in an internal medicine department, the fundus photography is perfomed, and the image is
remotely diagnosed by an ophthalmologist.
We will investigate whether this remote screening has the potential for early detection of diabetic retinopathy, which is a diabetic complication, and to improve medical efficiency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ophthalmic visit rate in diabetic patients during internal medicine visit
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are diagnosed with diabetes
early fasting blood glucose: 126 mg/dl or more
75g OGTT 2 hours later blood glucose level 200 mg/dl or more
HbA1c 6.5% or more
2) Outpatients whose registration date is over 20 years old
3)Patients who have obtained written consent from this person
Key exclusion criteria
1) Patients for whom prior consent has not been obtained in this study
2) Patients who have already lost visual acuity.
3) Patients who have difficulty opening their eyes due to ptosis when photographing the fundus
4) Patients who are unable to follow the doctor's instructions when taking pictures and cannot take pictures
5) Other patients judged inappropriate by doctors
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ogura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho, Nagoya, Japan
TEL
052-853-8251
ogura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Kato |
Organization
Nagoya City University Graduate School of Medical Sciences.
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho, Nagoya, Japan
TEL
052-853-8251
Homepage URL
akikato@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nikon Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research management center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-858-7215
ctmc@med.nagoya-cu.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
| 2019 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(21)00262-X/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(21)00262-X/fulltext
Number of participants that the trial has enrolled
499
Results
Four hundred ninety-nine patients (mean age, 62.5 years) were included. The duration of diabetes in 240 (48.1%) patients was less than 10 years and 433 (86.7%) patients had a hemoglobin (Hb) A1c below 8%. Regarding the retinopathy severity, 360 (72.1%) patients had no diabetic retinopathy (NDR), 63 (12.6%) mild nonproliferative retinopathy (NPDR), 38 (7.64%) moderate NPDR, 13 (2.6%) severe NPDR, and 25 (5.0%) PDR. Two hundred forty-one (48.3%) patients had an ophthalmologic consultation within 1 year.
Results date posted
| 2021 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
　Diabetic patients undergoing internal medicine
Participant flow
Study Description
Consent acquisition
Wide-angle fundus imaging
Adverse events
None
Outcome measures
The medical data
Severity of retinopathy,
Frequency of ophthalmologic visits
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 01 | Day |
Other
Other related information
This research is conducted with the cooperation of Kizawa Memorial Hospital and Fujishima Internal Clinic.
Management information
Registered date
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043040
