UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055870 |
|---|---|
| Receipt number | R000063582 |
| Scientific Title | Investigation and Examination of the Usability of the Soflet Blood Collection Device and Soflet Needles |
| Date of disclosure of the study information | 2024/10/18 |
| Last modified on | 2025/05/20 17:16:46 |
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Basic information
Public title
Investigation and Examination of the Usability of the Soflet Blood Collection Device and Soflet Needles
Acronym
Investigation and Examination of the Usability of the Soflet Blood Collection Device and Soflet Needles
Scientific Title
Investigation and Examination of the Usability of the Soflet Blood Collection Device and Soflet Needles
Scientific Title:Acronym
Investigation and Examination of the Usability of the Soflet Blood Collection Device and Soflet Needles
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usability of switching from the Gentlet blood glucose measurement puncture device and Gentlet needles to the Soflet and Soflet needles.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
usability of the device
Key secondary outcomes
Awareness regarding self-blood glucose measurement
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
Patients who meet all of the following criteria will be included in this study.
1) Diabetic patients aged 20 and over
2) Those who currently using the Gentlet blood glucose measurement puncture device and Gentlet needles, who have consented to switch to Soflet and Soflet needles
3) Those who have provided consent to participate in the study
Key exclusion criteria
Patients will be excluded from this study if they meet any of the following criteria:
1)Those who diagnosed with clear cognitive impairment, such as dementia or mild cognitive impairment (MCI)
2) Those whos with a mental illness
3) Those who currently participating in another study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katunori |
| Middle name | |
| Last name | Suzuki |
Organization
Niigata Diabetes Clinic
Division name
N/A
Zip code
950-1101
Address
478-9 Yamada Nishi-ku Niigata-city
TEL
025-370-1024
katsu-s@niigata-diabetes.jp
Public contact
Name of contact person
| 1st name | Katunori |
| Middle name | |
| Last name | Suzuki |
Organization
Niigata Diabetes Clinic
Division name
N/A
Zip code
950-1101
Address
478-9 Yamada Nishi-ku Niigata-city
TEL
025-370-1024
Homepage URL
katsu-s@niigata-diabetes.jp
Sponsor or person
Institute
Niigata Diabetes Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The clinical research ethical review board of Shido. Inc.
Address
614, 3-13-2 Kameari, Katsushika-ku, Tokyo
Tel
03-4500-5075
info@shido.co.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
新潟糖尿病クリニック（新潟県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
Results
Switching from conventional devices to Soflet improved the tolerance for blood glucose measurement. Over 80% of patients appreciated the reduced pain, the ease of removing the needle's protective cap, and the simplicity of setting the needle. This change also enhanced their motivation for future blood glucose measurement.
Results date posted
| 2025 | Year | 04 | Month | 28 | Day |
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
Main results already published
Date of protocol fixation
| 2024 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063582
