UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032358 |
|---|---|
| Receipt number | R000036896 |
| Scientific Title | Relationship between glucose fluctuation and hypoglycemia in type 1 diabetes |
| Date of disclosure of the study information | 2018/04/24 |
| Last modified on | 2018/04/24 10:59:47 |
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Basic information
Public title
Relationship between glucose fluctuation and hypoglycemia in type 1 diabetes
Acronym
Relationship between glucose fluctuation and hypoglycemia in type 1 diabetes
Scientific Title
Relationship between glucose fluctuation and hypoglycemia in type 1 diabetes
Scientific Title:Acronym
Relationship between glucose fluctuation and hypoglycemia 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
To evaluate whether Continuous Glucose Monitoring(CGM) improves glucose fluctuation and time in hypoglycemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time in Hypoglycemia
HbA1c
Glucose fluctuation
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Flash Glucose Monitoring
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
Type 1 diabetes(insulin dependent)
Key exclusion criteria
Patients were excluded if:
they were pregnant, thought likely to be pregnant or were planning to become pregnant during the study
they were receiving dialysis
they had complications or conditions that could affect their metabolic control or which were judged by the investigator to be likely to pose a threat to their safety
they were judged by the investigator to be ineligible for study participation.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
03-3433-1111
rimei@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
03-3433-1111
Homepage URL
rimei@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare in Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
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
東京慈恵会医科大学附属病院/ Jikei University Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 24 | Day |
Last modified on
| 2018 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036896
