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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name