UMIN-CTR Clinical Trial

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 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	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
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)、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
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	2018 Year 01 Month 31 Day
Date of IRB
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

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	2018 Year 11 Month 13 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
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Research case data
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