UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045065 |
|---|---|
| Receipt number | R000051384 |
| Scientific Title | Influence of self-injection method against insulin and GLP-1 receptor agonist to blood glucose control and weight change |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/02/06 08:11:38 |
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Basic information
Public title
Influence of self-injection method against insulin and GLP-1 receptor agonist to blood glucose control and weight change
Acronym
Influence of self-injection method to blood glucose control and weight change
Scientific Title
Influence of self-injection method against insulin and GLP-1 receptor agonist to blood glucose control and weight change
Scientific Title:Acronym
Influence of self-injection method to blood glucose control and weight change
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this study is to clarify how many patients carry out the self injection of insulin or GLP-1 receptor agonist appropriately. In addition, we examine the change of blood glucose control and body weight after the re-instruction of self injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation of the self-injection method by the questionary survey
Key secondary outcomes
1) Change of HbA1c and body weight before and after the questionary survey
2) Change of the dose of insulin or GLP-1 receptor agonist
3) Improvement of the injection method using the questionary survey four months later
4) Change of the blood test
5) Correlation with the cognitive function
6) Difference in recording contents and questionnaire result
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Over 18 years old
2) Self injection of insulin or GLP-1 receptor agonist for more than 3 months
3) Diabetes mellitus after the diagnosis of more than 3 months
4) The kind of a drug and the device does not matter
5) The patient with an agreement by the free will
Key exclusion criteria
1) The patient who cannot have a medical examination regularly
2) Severe infectious disease, before and after operation, or patient with the serious injury
3) In addition, the target person whom a manager for enforcement judged to be inappropriate as a study subject
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetology and Endocrinology, Department of Internal Medicine
Zip code
889-1692
Address
5200, Kihara, Miyazaki, Miyazaki, Japan
TEL
0985-85-9121
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetology and Endocrinology, Department of Internal Medicine
Zip code
889-1692
Address
5200, Kihara, Miyazaki, Miyazaki, Japan
TEL
0985-85-9121
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
Tel
0985-85-1510
rinken@med.miyazaki-u.ac.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
| 2021 | Year | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We prefer a questionnaire first and observe the patients until the next four months.
Management information
Registered date
| 2021 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051384
