UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055847 |
|---|---|
| Receipt number | R000063824 |
| Scientific Title | Effect of subcutaneous induration on insulin action of postprandial blood glucose |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2024/10/15 23:33:00 |
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Basic information
Public title
Examination of the effect of insulin injection at subcutaneous induration (insulin ball) on blood glucose after eating
Acronym
insulin ball test
Scientific Title
Effect of subcutaneous induration on insulin action of postprandial blood glucose
Scientific Title:Acronym
insulin ball test
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with diabetes treated with rapid insulin, compare the postprandial blood glucose profile after injection of insulin at skin with subcutaneous induration with after injection of insulin at skin without subcutaneous induration. Blood glucoses are measured with Free style ribre.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Asses the difference of 3 hour-postprandial blood glucose profile ,every 15mini. after insulin injection at skin with subcutaneous induration or without subcutaneous induration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
At 15 min. before test meal, inject insulin at skin with subcutaneous induration or without subcutaneous induration. After eating test meal, measure blood glucose every 15 min. by 3 hour.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with diabetes treated with very rapid insulin.
Key exclusion criteria
patients who have changed medicine or changed the dose of insulin within 1 month.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Okubo |
Organization
Wellness Clinic
Division name
internal medicine
Zip code
742-0021
Address
1547-1 Yanai Yanai Yamaguchi
TEL
0820-22-1024
mokubo@wellness-cl.jp
Public contact
Name of contact person
| 1st name | Masash |
| Middle name | |
| Last name | Okubo |
Organization
Wellness Clinic
Division name
internal medicine
Zip code
742-0021
Address
1547-1 Yanai Yanai Yamaguchi
TEL
0820-22-1024
Homepage URL
https://wellness-cl.jp/
mokubo@wellness-cl.jp
Sponsor or person
Institute
Wellness Clinic
Institute
Department
Personal name
Masashi Okubo
Funding Source
Organization
Wellness Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wellness Clinic
Address
1547-1 Yanai Yanai Yamaguchi
Tel
0820-22-1024
mokubo@wellness-cl.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 | 10 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063824
