UMIN-CTR Clinical Trial

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
Email	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
Email	akikato@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043040