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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018430
Receipt No. R000021313
Scientific Title Establishment of a new parameter of glycemic variability assessed by continuous glucose monitoring in type 1 diabetes.
Date of disclosure of the study information 2015/07/31
Last modified on 2015/08/04

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Basic information
Public title Establishment of a new parameter of glycemic variability assessed by continuous glucose monitoring in type 1 diabetes.
Acronym Establishment of a new parameter of glycemic variability in type 1 diabetes.
Scientific Title Establishment of a new parameter of glycemic variability assessed by continuous glucose monitoring in type 1 diabetes.
Scientific Title:Acronym Establishment of a new parameter of glycemic variability in type 1 diabetes.
Region
Japan

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

Objectives
Narrative objectives1 Establishment of a new parameter of glycemic variability in type 1 diabetes assessed by continuous glucose monitoring and comparison of the efficacy of long-acting insulin analogs
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Glycemic variability assessed by continuous glucose monitoring
Key secondary outcomes Glycemic control
Iusulin dose
Hypoglycemia

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Insulin degludec
administration period;12 weeks
The dosage was adjusted by the attending physician
Once daily
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

Not applicable
Gender Male and Female
Key inclusion criteria Aged over 20 years. Eligible participants had a known history of type 1 diabetes for at least 6 months, and had been treated for at least 6 months with a basal-bolus insulin regimen
Key exclusion criteria Severe chronic heart failure more than the 3 grade in the NYHA classification. Severely impaired hepatic or renal function. Severe infection, heavy use of alcohol, perioperative status, pregnant or breastfeeding women or other reasons leading to the physician in charge to judge that the patient was unsuitable for study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihisa Imagawa
Organization Graduate School of Medicine, Osaka University
Division name Department of Metabolic Medicine
Zip code
Address 2-2-B5 Yamadaoka, Suita 565-0871, Japan
TEL 06-6879-3732
Email aimagawa@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Iwasaki
Organization Graduate School of Medicine, Osaka University
Division name Department of Metabolic Medicine
Zip code
Address 2-2-B5 Yamadaoka, Suita 565-0871, Japan
TEL 06-6879-3732
Homepage URL
Email i-shingo@endmet.med.osaka-u.ac.jp

Sponsor
Institute Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Suita, Japan
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 大阪大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 27 Day
Last modified on
2015 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021313

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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