UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029332 |
|---|---|
| Receipt number | R000033528 |
| Scientific Title | Multicenter Survey of subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes |
| Date of disclosure of the study information | 2017/10/05 |
| Last modified on | 2018/08/06 15:22:57 |
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Basic information
Public title
Multicenter Survey of subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Acronym
Multicenter Survey of subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Scientific Title
Multicenter Survey of subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Scientific Title:Acronym
Multicenter Survey of subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Region
| Japan |
Condition
Condition
type 1 diabetes type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of study were to calculate subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Toal insulin dose
HbA1c(%)
Key secondary outcomes
Frequency of subcutaneous induration
Risk factors of subcutaneous induration
Frequency of hypoglycemia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The guidance of site rotation is performed once
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1,Patient who aged 65 years and over
2,Patient who treated insulin over a year
Key exclusion criteria
1,Patient who the attending physician judged impossible to participate
2,Unreceived informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunji horikawa |
Organization
JA Onomichi general Hospital
Division name
Department of pharmacy
Zip code
Address
Hirahara 1-10-23 Onomichi,Hiroshima,Japan
TEL
0848228111
shi.horikawa@hirokouren.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji horikawa |
Organization
JA Onomichi general Hospital
Division name
Department of pharmacy
Zip code
Address
Hirahara 1-10-23 Onomichi,Hiroshima,Japan
TEL
0848228111
Homepage URL
shi.horikawa@hirokouren.or.jp
Sponsor or person
Institute
JA Onomichi general Hospital
Department of pharmacy
Institute
Department
Personal name
Funding Source
Organization
JA Onomichi general Hospital
Hirahara 1-10-23 Onomichi,Hiroshima,Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ja Yoshida Hospital
Mihara Medical Association Hospital
Sera Central Hospital
Shobara Redcross Hospital
Miyoshi central Hospital
Kita Hiroshima Hospital
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
| 2017 | Year | 10 | Month | 05 | 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
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 06 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033528
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
