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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016588
Receipt No. 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 2018/06/07

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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
Middle name
Last name Takashi Murata
Organization NHO Kyoto Medical Center
Division name Diabetes Center
Zip code
Address 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
TEL 075-641-9161
Email murata-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Murata
Organization NHO Kyoto Medical Center
Division name Diabetes Center
Zip code
Address 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
TEL 075-641-9161
Homepage URL
Email murata-tky@umin.net

Sponsor
Institute NHO Kyoto Medical Center
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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 No longer recruiting
Date of protocol fixation
2014 Year 12 Month 15 Day
Date of IRB
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

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
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019246

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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