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
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
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
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
