UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021172 |
|---|---|
| Receipt number | R000024384 |
| Scientific Title | Evaluation of risk of glucose fluctuation during nighttime by Average Daily Risk Range (ADRR) in type 1 diabetes |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2017/10/06 13:43:36 |
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Basic information
Public title
Evaluation of risk of glucose fluctuation during nighttime by Average Daily Risk Range (ADRR) in type 1 diabetes
Acronym
Evaluation of risk of glucose fluctuation during nighttime by ADRR in type 1 diabetes
Scientific Title
Evaluation of risk of glucose fluctuation during nighttime by Average Daily Risk Range (ADRR) in type 1 diabetes
Scientific Title:Acronym
Evaluation of risk of glucose fluctuation during nighttime by ADRR 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 investigate the relations between ADRR and glucose fluctuation at nighttime evaluated by continuous glucose monitoring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between frequencies of hypoglycemia (below 70mg/dl), hyperglycemia (200mg/dl and over) and mean blood glucose during nighttime (0:00-5:59) and ADRR
Key secondary outcomes
Correlations between frequencies of hypoglycemia (below 70mg/dl), hyperglycemia (200mg/dl and over) and mean blood glucose during daytime (6:00-23:59) and ADRR
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) Age 20 and ove, below 80 at consent
2) Type 1 diabetes
3) Patients who can do SMBG three times
a day
4) Provided written informed consent
Key exclusion criteria
1) Patients with liver cirrhosis and
renal failure (hemodialysis and serum
creatinine 2.0mg/dl and over)
2) Pregnant patients
3) Malignancy
4) Considered inadequate by the
investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
Hongo 2-1-1, Bunkyo-ku
TEL
03-3813-3111
akana@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
Hongo 2-1-1, Bunkyo-ku
TEL
03-3813-3111
Homepage URL
akana@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 25 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment period: 2016.3.4-2017.8.31
Study design: Participants: type 1 diabetes with intensive insulin therapy.
At the next visit after informed consent, CGM has been performed for 6 days. At the same time, SMBG has also been performed three times daily for 14 days until the next visit after 4-8 weeks. Then, ADRR is calculated based on the results of SMBG. After that, association between the ADRR and CGM data is investigated. During the study periods, dosage of insulin is not changed in principle. And calculation of ADRR is performed by the method reported previously (Kovatchev et al.2006 Diabetes care).
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2017 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
