UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037845 |
|---|---|
| Receipt number | R000043147 |
| Scientific Title | Exploratory evaluation of glycemic control improvement of patients with diabetes by appropriate insulin injection technique |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2022/10/13 09:38:53 |
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Basic information
Public title
Exploratory evaluation of glycemic control improvement of patients with diabetes by appropriate insulin injection technique
Acronym
Exploratory evaluation of glycemic control improvement
Scientific Title
Exploratory evaluation of glycemic control improvement of patients with diabetes by appropriate insulin injection technique
Scientific Title:Acronym
Exploratory evaluation of glycemic control improvement
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate improvement of glycemic control by implementing appropriate education on insulin injection techniques and the new pen needle for insulin injection to those patients with diabetes who undergo insulin therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute mean reduction in HbA1c between the baseline and the end of the observation period
Key secondary outcomes
1)Number and percentage of patients with reduced HbA1c at the end of the observation period
2)Reduction rate in HbA1c between the baseline and the end of the observation period
3)Absolute mean reduction in total daily insulin dose between the baseline and the end of the observation period
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Female and male outpatients with diabetes aged at 20 or over
2)Patients with insulin injection history of 1 years or more
3)Patients with no history of hospitalization within six months prior to the enrollment
4)Patients with insulin injection 3+ times a day
5)Patients on the new pen needle for insulin injection or will be prescribed with it
6)Patients with ability to understand and execute instructed insulin injection technique
7)Patients with ability to provide written informed consent
Key exclusion criteria
1)Pregnant patients or patients with suspected pregnancy
2)Patients who take steroid treatment with dose changing in follow-up period
3)Patients with malignant disease undergoing treatment.
4)Patients whom a principal investigator determines as inappropriate
5)Patients who refuse to provide an informed consent or to participate in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Hamasaki |
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
530-8480
Address
2-4-20, Ohgi-machi Kita-ku, Osaka, 530-8480 Japan
TEL
06-6312-1221
a-hamasaki@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Shusaku |
| Middle name | |
| Last name | Tozaka |
Organization
Nippon Becton Dickinson Company, Ltd.
Division name
Medical Affairs
Zip code
107-0052
Address
4-15-1, Akasaka, Minato-ku, Tokyo, 107-0052 Japan
TEL
03-6234-5628
Homepage URL
shusaku_tozaka@bd.com
Sponsor or person
Institute
Tazuke Kofukai Medical Research Institute Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Address
2-4-20, Ohgi-machi Kita-ku, Osaka, 530-8480 Japan
Tel
06-6312-1221
rinshou@kitano-hp.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
公益財団法人田附興風会医学研究所北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 15 | 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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
-
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043147
