UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006894
Receipt number R000008147
Scientific Title Suitable algorithm for bolus insulin calculation in insulin pump therapy
Date of disclosure of the study information 2012/01/01
Last modified on 2015/06/17 09:38:26

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Basic information

Public title

Suitable algorithm for bolus insulin calculation in insulin pump therapy

Acronym

algorithm for bolus insulin on insulin pump

Scientific Title

Suitable algorithm for bolus insulin calculation in insulin pump therapy

Scientific Title:Acronym

algorithm for bolus insulin on insulin pump

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 determine a suitable argorithm for calculating bolus insulin dose in insulin pump yherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Carbohydrate-to-insulin ratio and total daily dose of insulin

Key secondary outcomes



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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1.insulin dependent (serum C-peptide < 0.5 ng/ml)
2.indication for insulin pump

Key exclusion criteria

1.Patients suffering from severe infection, prior- or post-surgery, and severe injurry
2. Use of drugs, which affecs glucose metabolism, such as steroids.
3. Patients who are considered to be inappropriate for this trial by physician.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Munehide Matsuhsia

Organization

Tokushima University

Division name

Diabetes Therapeutics and Research Center

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan

TEL

088-633-7587

Email

matuhisa@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akio Kuroda

Organization

Tokushima University

Division name

Diabetes Therapeutics and Research Center

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan

TEL

088-633-7587

Homepage URL


Email

kurodaakio@tokushima-u.ac.jp


Sponsor or person

Institute

Diabetes Therapeutics and Research Center, Tokushima University

Institute

Department

Personal name



Funding Source

Organization

Diabetes Therapeutics and Research Center, Tokushima University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Metabolic Medicine, Osaka University Graduate School of Medicine

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

徳島大学病院、大阪大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://online.liebertpub.com/doi/abs/10.1089/dia.2012.0109

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

Enrolling by invitation

Date of protocol fixation

2011 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry

2013 Year 12 Month 15 Day

Date trial data considered complete

2013 Year 12 Month 20 Day

Date analysis concluded

2014 Year 02 Month 01 Day


Other

Other related information

Trial is going on


Management information

Registered date

2011 Year 12 Month 16 Day

Last modified on

2015 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008147


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name