UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054511 |
|---|---|
| Receipt number | R000062116 |
| Scientific Title | Reliability and validity of the Diabetes Knowledge Test (for patients receiving frequent insulin injections) |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/30 11:51:29 |
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Basic information
Public title
Reliability and validity of the Diabetes Knowledge Test for patients receiving frequent insulin injections
Acronym
Reliability and validity of the Diabetes Knowledge Test for patients receiving frequent insulin injections
Scientific Title
Reliability and validity of the Diabetes Knowledge Test (for patients receiving frequent insulin injections)
Scientific Title:Acronym
Reliability and validity of the Diabetes Knowledge Test (for patients receiving frequent insulin injections)
Region
| Japan |
Condition
Condition
Patients with type1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the knowledge necessary to use frequent insulin injections among type1 diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate Cronbach alfa coefficient of this knowledge test undergone after the lectures.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Type 1 diabetic outpatients with decreased endogenous insulin secretion
2)Patients who are insulin dependent with fasting CPI (CPR ng/mL/fasting blood glucose mg/dL) within 0.6.
3)Patients who are 20 years or older at the time of study inclusion
4)Patients whose written consent has been obtained to participate in the study
Key exclusion criteria
1)Patients taking steroids
2)Patients who are pregnant or breastfeeding
3)Patients with malignant tumor (patients with recurrence-free period of less than 5 years)
4)Patients with me judged to be inappropriate to participate in this study by the research staff
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Tsuchiya |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10 Konandai, Konan-ku, Yokohama, Kanagawa, Japan
TEL
045-832-1111
kasuya.m.0226@gmail.com
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Tsuchiya |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10 Konandai, Konan-ku, Yokohama, Kanagawa, Japan
TEL
045-832-1111
Homepage URL
kasuya.m.0226@gmail.com
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Nanbu Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Nanbu Hospital
Address
3-2-10 Konandai, Konan-ku, Yokohama, Kanagawa, Japan
Tel
045-832-1111
soumu01@nanbu.saiseikai.or.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
| 2024 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional study to examine the knowledge necessary for using insulin among patients receiving frequent insulin injections.
Management information
Registered date
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062116
