Unique ID issued by UMIN | UMIN000037782 |
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Receipt number | R000043075 |
Scientific Title | Flash glucose monitoring in elderly diabetic patients at home Usefulness of blood glucose trend analysis and specialist intervention |
Date of disclosure of the study information | 2019/08/26 |
Last modified on | 2023/08/30 11:28:40 |
Usefulness of blood glucose control using Flash Glucose Monitoring in patients with diabetes at home
FGM at home
Flash glucose monitoring in elderly diabetic patients at home Usefulness of blood glucose trend analysis and specialist intervention
Usefulness of FGM in elderly diabetic patients at home
Japan |
Diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To examine the effectiveness of Flash Glucose Monitoring, a non-insurance continuous blood glucose measurement system for home patients.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Evaluation of blood glucose monitor operation using continuous glucose monitoring systems in home medical care
1.Identification of hypoglycemia events by CGMS
2.Treatment intervention by specialists based on CGMS analysis results and reduction in the number of hypoglycemic events
3.Safety assessment of CGM device puncture procedure by visiting nurses
4.Life improvement effect by dietitian intervention based on CGMS analysis results
5.Improvement of QOL that can be obtained from home patients by blood glucose monitoring by CGMS
6.Problems of home diabetes management revealed by CGMS
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Prevention
Device,equipment |
Equipped with Flash Glucose Monitoring up to 14 days. Analyze the data and then devise treatment by a specialist. After a sufficient period of time, FGM will be applied again and post-analysis will be conducted to assess efficacy.
Not applicable |
Not applicable |
Male and Female
1.Patients who are undergoing home visits and have Diabetes (regardless of disease type)registered as the disease name.
2.Preferentially select patients who are receiving diabetes treatment (insulin, SU, etc.) that are likely to induce hypoglycemia
3.During the visit, Libre pro sensor was attached and collected, and subsequent data analysis and treatment intervention by diabetes specialists and medical instructors were accepted.
4.Patients who can cooperate in filling out the check sheet (using DTR-QOL) on health management QOL by the patient or family.
1.Patients with other electronic devices such as pacemakers.
2.Patients who are scheduled to undergo imaging examinations such as X-ray and MRI within one month
3.Other patients who are determined to be unsuitable for conducting this study safely by the principal investigator or doctor in charge.
20
1st name | Takuya |
Middle name | |
Last name | Watanabe |
Saku central hospital advanced care center
Endocrinology and metabolism
385-0051
Nakagomi, Saku-shi, Nagano 385-0051, Japan
0267-82-8181
takuyaw.yks@gmail.com
1st name | Takuya |
Middle name | |
Last name | Watanabe |
Saku central hospital advanced care center
Endocrinology and metabolism
385-0051
Nakagomi, Saku-shi, Nagano 385-0051, Japan
0267-82-8181
takuyaw.yks@gmail.com
Saku central hospital advanced care center
department of endocrinology and metabolism
Nothing
Other
Saku Central Hospital Group Research Ethics Committee
197 Usuda, Saku, 384-0301 JAPAN
0267-82-3131
ctroffice@sakuhp.or.jp
NO
2019 | Year | 08 | Month | 26 | Day |
nothing
Unpublished
nothing
0
Not found
2019 | Year | 08 | Month | 23 | Day |
Delay expected |
Now proceeding
Nothing
Nothing
Nothing
Nothing
Nothing
Nothing
Terminated
2018 | Year | 08 | Month | 04 | Day |
2018 | Year | 08 | Month | 04 | Day |
2018 | Year | 08 | Month | 04 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
2019 | Year | 08 | Month | 23 | Day |
2023 | Year | 08 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043075
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