UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019539 |
|---|---|
| Receipt number | R000022597 |
| Scientific Title | A study of a relationship between morning glycemic variability using CGM in patients with type 2 diabetes(retrospective study) |
| Date of disclosure of the study information | 2015/10/29 |
| Last modified on | 2016/03/03 18:14:06 |
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Basic information
Public title
A study of a relationship between morning glycemic variability using CGM in patients with type 2 diabetes(retrospective study)
Acronym
A study of a relationship between morning glycemic variability
Scientific Title
A study of a relationship between morning glycemic variability using CGM in patients with type 2 diabetes(retrospective study)
Scientific Title:Acronym
A study of a relationship between morning glycemic variability
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the assosiation between morning glycemic valiability and patient charactaristic.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The parameters used as indices for glycemic variability included highest postprandial glucose level within 3 h after breakfast, time from start of breakfast to the highest postprandial glucose level, difference between pre-breakfast and highest postprandial breakfast glucose levels, area under the curve (AUC) (>180 mg/dL) for glycemic variability within 3 h after breakfastand post-breakfast glucose gradient. We analyzed the associations between these factors (response variables, respectively) and patient charactaristic (explanatory variables) using multiple regression analysis.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
106 patients with type 2 diabetes who underwent CGM during admission.
Key exclusion criteria
Patients who were aware of their hypoglycemia and took glucose tablets, and those who had been taking a-glucosidase inhibitors
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
TEL
0586-48-0077
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1, Kaimei-hira, Ichinomiya-city, Aichi
TEL
0586-48-0077
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Ichinomiyanishi Hospital
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 | 29 | 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
| 2015 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross sectional study
We retrospectively analyzed 106 patients with type 2 diabetes who underwent CGM during admission during a 2-year period from 2013 to 2015. Patients who were aware of their hypoglycemia and took glucose tablets, and those who had been taking a-glucosidase inhibitors were excluded. The parameters used as indices for glycemic variability included highest postprandial glucose level within 3 h after breakfast, time from start of breakfast to the highest postprandial glucose level, difference between pre-breakfast and highest postprandial breakfast glucose levels, area under the curve (AUC) (>180 mg/dL) for glycemic variability within 3 h after breakfastand post-breakfast glucose gradient. We analyzed the associations between these factors (response variables, respectively) and patient charactaristic (age, sex, duration of diabetes, BMI, HbA1c, CPR, FPG, CPI)(explanatory variables) using multiple regression analysis.
Management information
Registered date
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022597
