Unique ID issued by UMIN | UMIN000016588 |
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Receipt number | R000019246 |
Scientific Title | Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study |
Date of disclosure of the study information | 2015/02/20 |
Last modified on | 2020/08/24 17:43:19 |
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study (PARCS study)
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study (PARCS study)
Japan |
Type 1 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
This study is aimed to investigate the factors that predict the good adherence of real-time continuous glucose monitoring (CGM) sensor among patients with type 1 diabetes mellitus.
Safety,Efficacy
Characteristics of the patients with sensor adherence not less than 60%.
HbA1c, body weight, blood pressure, insulin dosage, severity of diabetes complications, public services of medical expense support, QOL, frequency of severe hypoglycemia, severe adverse events (death, admission by DKA, admission by severe hypoglycemia), other adverse events.
Observational
15 | years-old | <= |
Not applicable |
Male and Female
Patients with type 1 diabetes mellitus who regularly visit or being hospitalized at the medical institute participating this study, have experience of using insulin pump for not less than one year, and wish to use sensor-augmented insulin pump (SAP).
(1) Patients who have experience of using SAP or real-time CGM before the start of this study.
(2) Patients who are pregnant or under preconceptional care.
(3) Ptatients younger than 15 years old.
100
1st name | Takashi |
Middle name | |
Last name | Murata |
NHO Kyoto Medical Center
Diabetes Center
612-8555
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
075-641-9161
murata-tky@umin.net
1st name | Takashi |
Middle name | |
Last name | Murata |
NHO Kyoto Medical Center
Diabetes Center
612-8555
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
075-641-9161
murata-tky@umin.net
NHO Kyoto Medical Center
None
Self funding
NHO Kyoto Medical Center, Ethics Committee
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
075-641-9161
yamaji.hirofumi.bg@mail.hosp.go.jp
NO
国立病院機構京都医療センター(京都府)(NHO Kyoto Medical Center, Kyoto)、徳島大学病院(徳島県)(Tokushima University, Tokushima)、東海大学医学部付属病院(神奈川県)(Tokai University School of Medicine, Kanagawa)、神戸大学医学部附属病院(兵庫県)(Kobe University Hospital, Hyogo)、国立病院機構大阪医療センター(大阪府)(NHO Osaka Medical Center, Osaka)、有澤総合病院(大阪府)(Arisawa General Hospital, Osaka)、岡山大学病院(岡山県)(Okayama University Hospital, Okayama)、神田内科クリニック(Kanda Naika Clinic, Osaka)、岡田内科クリニック(Okada Clinic, Fukuoka)
2015 | Year | 02 | Month | 20 | Day |
None.
Published
https://journals.sagepub.com/doi/full/10.1177/1932296820939204
46
60.9% of the participants were classified as adherent. The duration of using CSII was longer in the adherent group, and the degree of diabetic retinopathy was significantly different. The Problem Areas in Diabetes (PAID) score at baseline was significantly higher and the total CSII-QOL score at baseline was significantly lower in the adherent group.
2020 | Year | 08 | Month | 24 | Day |
2020 | Year | 08 | Month | 07 | Day |
The mean age of the 46 participants was 44.1 years old and the mean glycohemoglobin (HbA1c) was 7.7%.
Participants were followed up for one year.
No severe adverse event (death, DKA requiring hospitalization and severe hypoglycemia requiring hospitalization) was observed.
Diabetes related QOL, etc.
Completed
2014 | Year | 12 | Month | 15 | Day |
2014 | Year | 12 | Month | 15 | Day |
2015 | Year | 02 | Month | 24 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 06 | Month | 06 | Day |
2020 | Year | 05 | Month | 22 | Day |
This study is aimed to investigate the relationship between the baseline characteristics (age, glycemic control, QOL, income levels and etc.) prior to SAP usage and the sensor adherence during the observation period. Secondary endpoints are the change of glycemic control, frequency of adverse events and their relationship to the baseline characteristics.
2015 | Year | 02 | Month | 20 | Day |
2020 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019246
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