UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016588 |
|---|---|
| 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 |
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Basic information
Public title
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study
Acronym
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study (PARCS study)
Scientific Title
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study
Scientific Title:Acronym
Predictive Factors of the Adherence to the Real-time CGM Sensors: A Prospective Observational Study (PARCS study)
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Characteristics of the patients with sensor adherence not less than 60%.
Key secondary outcomes
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.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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).
Key exclusion criteria
(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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Murata |
Organization
NHO Kyoto Medical Center
Division name
Diabetes Center
Zip code
612-8555
Address
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
TEL
075-641-9161
murata-tky@umin.net
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Murata |
Organization
NHO Kyoto Medical Center
Division name
Diabetes Center
Zip code
612-8555
Address
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
TEL
075-641-9161
Homepage URL
murata-tky@umin.net
Sponsor or person
Institute
NHO Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
NHO Kyoto Medical Center, Ethics Committee
Address
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
Tel
075-641-9161
yamaji.hirofumi.bg@mail.hosp.go.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
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)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
None.
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.1177/1932296820939204
Number of participants that the trial has enrolled
46
Results
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.
Results date posted
| 2020 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 07 | Day |
Baseline Characteristics
The mean age of the 46 participants was 44.1 years old and the mean glycohemoglobin (HbA1c) was 7.7%.
Participant flow
Participants were followed up for one year.
Adverse events
No severe adverse event (death, DKA requiring hospitalization and severe hypoglycemia requiring hospitalization) was observed.
Outcome measures
Diabetes related QOL, etc.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 06 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 22 | Day |
Other
Other related information
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.
Management information
Registered date
| 2015 | Year | 02 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019246
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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