UMIN-CTR Clinical Trial

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
Email	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
Email	shusaku_tozaka@bd.com

Sponsor
Institute	Tazuke Kofukai Medical Research Institute Kitano Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043147