UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031595
Receipt number 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 13:48:15

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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 or person

Institute

NHO Kyoto Medical Center

Institute

Department

Personal name



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

Value
https://center6.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