UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025177
Receipt number R000027986
Scientific Title Investigation of the current state of diabetes care and the effect of childhood diabetes seminar in pediatric patients with diabetes
Date of disclosure of the study information 2018/12/31
Last modified on 2021/06/11 15:50:01

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Basic information

Public title

Investigation of the current state of diabetes care and the effect of childhood diabetes seminar in pediatric patients with diabetes

Acronym

Investigation of diabetes care and diabetes seminar in pediatric patients with diabetes

Scientific Title

Investigation of the current state of diabetes care and the effect of childhood diabetes seminar in pediatric patients with diabetes

Scientific Title:Acronym

Investigation of diabetes care and diabetes seminar in pediatric patients with diabetes

Region

Japan


Condition

Condition

pediatric diabetes

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To understand the current state of diabetes care in pediatric patients with diabetes. To assess the effects of pediatric diabetes seminars.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in the hemoglobin HbA1c values and the frequency of hypoglycemia after 2 month from diabetes seminars

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

participating in diabetes seminar

Interventions/Control_2

not participating in diabetes seminar

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


Not applicable

Age-upper limit

20 years-old >

Gender

Male and Female

Key inclusion criteria

children with diabetes and their families in Shiga prefecture

Key exclusion criteria

not obtaining the consent for investigation

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katuyuki Matsui

Organization

Shiga University of medical science

Division name

Pediatrics

Zip code


Address

Tsukinowa-cho, Seta, Otsu, Shiga Prefecture, Japan

TEL

81-77-548-2228

Email

kmatsui@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katuyuki Matsui

Organization

Shiga University of medical science

Division name

Pediatrics

Zip code


Address

Tsukinowa-cho, Seta, Otsu, Shiga Prefecture, Japan

TEL

81-77-548-2228

Homepage URL


Email

kmatsui@belle.shiga-med.ac.jp


Sponsor or person

Institute

Pediatrics department
Shiga University of medical science

Institute

Department

Personal name



Funding Source

Organization

Shiga prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 12 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2016 Year 11 Month 30 Day

Date of IRB

2016 Year 12 Month 06 Day

Anticipated trial start date

2016 Year 12 Month 11 Day

Last follow-up date

2017 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 07 Day

Last modified on

2021 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name