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

Email

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

Email

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

Email

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