UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018430 |
|---|---|
| Receipt number | 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 21:45:00 |
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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
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
i-shingo@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Suita, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021313
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
