UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019190 |
|---|---|
| Receipt number | R000022167 |
| Scientific Title | The relationship between HbA1c values and the occurrence of hypoglycemia as assessed by continuous glucose monitoring in patients with type 1 diabetes |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2016/10/01 11:30:06 |
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Basic information
Public title
The relationship between HbA1c values and the occurrence of hypoglycemia as assessed by continuous glucose monitoring in patients with type 1 diabetes
Acronym
Type 1 diabetes CGM study
Scientific Title
The relationship between HbA1c values and the occurrence of hypoglycemia as assessed by continuous glucose monitoring in patients with type 1 diabetes
Scientific Title:Acronym
Type 1 diabetes CGM study
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to examine the relationship between the occurrence of hypo-/ hyperglycemia and HbA1c values, as assessed by continuous glucose monitoring (CGM) in patients with type 1 diabetes.
Basic objectives2
Others
Basic objectives -Others
understanding the disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24-hour mean glucose values and their standard deviations (SDs), time in hypoglycemia, time in nocturnal hypoglycemia, and time in hyperglycemia.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 1 diabetes being treated with basal-bolus insulin therapy at our hospital
Key exclusion criteria
continuous subcutaneous insulin infusion (CSII)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Tsujino |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-15-8 Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
dtsujino7777@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Tsujino |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-15-8 Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
dtsujino7777@gmail.com
Sponsor or person
Institute
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University 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
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The inclusion criteria of the study subjects is type 1 diabetic patients on basal-bolus insulin therapy who were put on CGM from October, 2010.
Management information
Registered date
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2016 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022167
