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
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
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
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
