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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025177
Receipt No. 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 2016/10/05

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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
0 years-old <=
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
Institute Pediatrics department
Shiga University of medical science
Institute
Department

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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 11 Day
Last follow-up date
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
2016 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.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


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