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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013136
Receipt No. R000015318
Scientific Title Adequate adjustment from insulin degludec to insulin pump therapy in patient with type 1 diabetes
Date of disclosure of the study information 2014/02/12
Last modified on 2014/02/12

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Basic information
Public title Adequate adjustment from insulin degludec to insulin pump therapy in patient with type 1 diabetes
Acronym From Degludec to insulin pump study
Scientific Title Adequate adjustment from insulin degludec to insulin pump therapy in patient with type 1 diabetes
Scientific Title:Acronym From Degludec to insulin pump study
Region
Japan

Condition
Condition type 1 diabetes
Classification by specialty
Endocrinology and Metabolism Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the timing of starting basal insulin dose with insulin pump from insulin degludec by Continuous Glucose Monitoring (CGM)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUC (area under the curve) for 8 hours from 24 hour after the last injection of insulin Degludec
Key secondary outcomes mean blood glucose value, Standard Deviation (SD), HbA1c

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients in Group 1 use degludec for 1 month. They start basal insulin infusion by insulin pump 24 hour after from last degludec injection.
Interventions/Control_2 Patients in Group 2 use degludec for 1 month. They start basal insulin infusion by insulin pump 36 hour after from last degludec injection.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria type 1 diabetes patients over 16 years old whose HbA1c is under 7.5%.
Key exclusion criteria patient who is under15 years old.
patient whose HbA1c is over 7.5%
patient with severe diabetes complication.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Kawamura
Organization Osaka City University Graduate school of Medicine
Division name Department of Pediatrics
Zip code
Address 1-5-7 Asahi-machi Abeno-ku Osaka, Japan
TEL 06-6645-3816
Email kawam@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Hirose
Organization Osaka City University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 1-5-7 Asahi-machi Abeno-ku Osaka, Japan
TEL 06-6645-3816
Homepage URL
Email hirose810@med.osaka-cu.ac.jp

Sponsor
Institute Department of Pediatrics Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Pediatrics Osaka City University Graduate School of Medicine
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 大阪市立大学付属病院小児科

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 12 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 07 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 12 Day
Last modified on
2014 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015318

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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