Unique ID issued by UMIN | UMIN000045329 |
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Receipt number | R000051760 |
Scientific Title | Examining the effectiveness of glycemic control intervention program by Digital technology and human for diabetes prevention |
Date of disclosure of the study information | 2021/09/10 |
Last modified on | 2021/08/31 18:26:07 |
Examining the effectiveness of glycemic control intervention program by Digital technology and human for diabetes prevention
Examining the effectiveness of glycemic control intervention program by Digital technology and human for diabetes prevention
Examining the effectiveness of glycemic control intervention program by Digital technology and human for diabetes prevention
Examining the effectiveness of glycemic control intervention program by Digital technology and human for diabetes prevention
Japan |
Healthy adults
Adult |
Others
NO
To verify the effectiveness of glycemic control intervention program by digital technology and human.
Efficacy
Estimated HbA1c at 1W, 2W, 3W, 4W, 11W, 12W
The items below are evaluated at 1W, 2W, 3W, 4W, 11W, 12W.
Average blood glucose level
Standard deviation of blood glucose level
Time In Range
Percentage of time above Time In Range
Percentage of time below Time In Range
Number of low glucose events
Number of spikes
Number of scans by reader
The items below are evaluated at 1W, 4W, 8W, 12W.
Weight and BMI
Behavioral change score
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Device,equipment | Behavior,custom |
Measuring blood glucose level by freestyle libre at 1W, 2W, 3W, 4W, 11W, and 12W, provision of messages between 2W and 12W and doctor reports after 1W and 4W by app, interview guidance by registered dietitian at 4W, 8W, and 12W
30 | years-old | <= |
64 | years-old | >= |
Male and Female
1) Consent was obtained from the subject before participating in this study
2) Age shall be 30-64 years old at the time of consent acquisition
3) Gender does not matter
4) HbA1c was 5.6% -6.4% in the results of medical check within the last 2 years.
5) If the subject was diagnosed with hypertension or dyslipidemia, the subject was not diagnosed with diabetes
6) The subject can understand the purpose of research and use freestyle libre properly
7) The subject uses smartphone on a daily basis
1) Diagnosed with diabetes
2) Suffering from severe kidney disease, liver disease, heart disease, malignant tumor, etc.
3) May be pregnant or within 1 year of delivery
4) Researchers consider it inappropriate for subjects to participate in the study
60
1st name | Daisuke |
Middle name | |
Last name | Kuriyama |
SOMPO Health Support Inc.
Business Planning Department
101-0063
Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo
0352098500
dkuriyama45@sompo-hs.co.jp
1st name | Hiromasa |
Middle name | |
Last name | Ida |
SOMPO Health Support Inc.
Business Planning Department
101-0063
Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo
0352098523
hida89@sompo-hs.co.jp
Sompo Himawari Life Insurance Inc.
Sompo Himawari Life Insurance Inc.
Profit organization
Kyorindo Pharmacy
NPO MINS IRB
ST Shibuya Building, Dougenzaka 1-15-14, Shibuya-ku, Tokyo
0364169032
npo-mins@j-irb.com
NO
2021 | Year | 09 | Month | 10 | Day |
Unpublished due to the protocol including the intellectual property rights
Unpublished
Working in progress
59
Significant differences were found in the primary and secondary endpoints.
2021 | Year | 08 | Month | 31 | Day |
Healthy adults
59 subjects participated in the study and 58 subjects completed were incorporated into the analyses
Mild and Moderate inflammation on the site where Libre sensors were attached to two subjects were occurred.
Blood glucose level and behavior change
Completed
2020 | Year | 09 | Month | 30 | Day |
2020 | Year | 10 | Month | 14 | Day |
2020 | Year | 10 | Month | 15 | Day |
2021 | Year | 02 | Month | 14 | Day |
2021 | Year | 08 | Month | 31 | Day |
2021 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051760
Research Plan | |
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