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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031595
Receipt No. R000035409
Scientific Title Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII)
Date of disclosure of the study information 2018/03/06
Last modified on 2019/10/25

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Basic information
Public title Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII)
Acronym Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) (CSII-QOL study)
Scientific Title Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII)
Scientific Title:Acronym Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) (CSII-QOL 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 To develop and validate new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII).
Basic objectives2 Others
Basic objectives -Others Validity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Validity and reliability of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII)
Key secondary outcomes Relationship between CSII-QOL score and baseline measurements {HbA1c, age, sex, BMI, present history (diabetes duration, history of insulin therapy, history of CSII), type of insulin pump, insulin dosage (total daily dose, total basal dose), diabetic retinopathy, diabetic nephropathy, QOL (Problem Areas in Diabetes: PAID)}.

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 (1) Type 1 diabetes.
(2) Patients using insulin pump for no less than one year.
(3) Patients who regularly visit or being hospitalized at the medical institute participating this study.
Key exclusion criteria (1) Type 2 diabetes.
(2) Patients who are not suitable to participate in this study for any other reasons.
Target sample size 50

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
Email 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
Email murata-tky@umin.net

Sponsor
Institute NHO Kyoto Medical Center
Institute
Department

Funding Source
Organization Self-funding
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
Email 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)、岡山大学病院(岡山県)( Okayama University Hospital, Okayama)、澤木内科・糖尿病クリニック(Sawaki Internal Medicine and Diabetes Clinic)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 06 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/31638420
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31638420
Number of participants that the trial has enrolled 50
Results 
The final 25-item questionnaire had a three-domain structure ("convenience", "social restriction", and "psychological problems"), high internal consistency (Cronbach's alpha = 0.870), and substantial test-retest reliability (intraclass correlation coefficient = 0.65). The CSII-QOL score was correlated negatively with the Problem Areas in Diabetes (PAID) score.
Results date posted
2019 Year 10 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 10 Month 22 Day
Baseline Characteristics 
28% males; age, 47.6 years old.
Participant flow 
The study participants responded twice to the self-reporting questionnaire at the interval of 1 week or more to less than 13 weeks.
Adverse events 
N.A.
Outcome measures 
Validity and reliability of the new self-reporting questionnaire.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
2015 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 03 Month 06 Day
Last follow-up date
2018 Year 10 Month 12 Day
Date of closure to data entry
2018 Year 11 Month 09 Day
Date trial data considered complete
2018 Year 11 Month 09 Day
Date analysis concluded
2019 Year 09 Month 26 Day

Other
Other related information This study is aimed to validate the newly developed self-administrated questionnaire (CSII-QOL) to assess the quality of life (QOL) regarding continuous subcutaneous insulin infusion (CSII). After obtaining written informed consent, 50 subjects aged 15 years old or more are requested to fill in CSII-QOL questionnaire and Problem Areas in Diabetes (PAID) questionnaire. The subjects are requested to fill in the same questionnaire again after 1 week or more and before less than 13 weeks. The obtained information will be anonymized and be analyzed for the validity and reliability.

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2019 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035409

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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