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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030696
Receipt No. R000034864
Scientific Title Correlation between glucose variability evaluated by CGMS and labile hemoglobin A1c measured by high performance liquid chromatography (HPLC) in Japanese patients with diabetes.
Date of disclosure of the study information 2018/10/01
Last modified on 2018/01/05

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Basic information
Public title Correlation between glucose variability evaluated by CGMS and labile hemoglobin A1c measured by high performance liquid chromatography (HPLC) in Japanese patients with diabetes.
Acronym Correlation between glucose variability and labile hemoglobin A1c.
Scientific Title Correlation between glucose variability evaluated by CGMS and labile hemoglobin A1c measured by high performance liquid chromatography (HPLC) in Japanese patients with diabetes.
Scientific Title:Acronym Correlation between glucose variability and labile hemoglobin A1c.
Region
Japan

Condition
Condition diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the correlation between glucose variability evaluated by CGMS and labile HbA1c measured by HPLC in Japanese patients with diabetes.
Basic objectives2 Others
Basic objectives -Others To compare the correlativity of surrogate markers of bood glucose (labile HbA1c, stable HbA1c, 1,5-Anhydroglucitol, glycated albumin) measured by HPLC for glucose variability evaluated by CGMS.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To calculate the coefficient and 95% interval(CI) between the values of labile HbA1c measured by HPLC and standard deviation (SD) of 24-hr glucose concentration measured by CGM prior
to evaluate labile HbA1c.
Key secondary outcomes To calculate the coefficient and 95% interval(CI) between the values of labile HbA1c and mean glucose level or mean amplitude of glycemic excursions(MAGE).

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

Not applicable
Gender Male and Female
Key inclusion criteria Inpatients with all types of diabetes with informed consent.
Key exclusion criteria Patients who fall into any of the following criteria are unable to participate in the study.
1)patients who are considered to be ineligible for the study by the attending doctor,2)sever renal dysfunction(estimated glomerular filtration rate<45mL/min/1.73m2) or nephrotic syndrome,3)high blood urea nitrogen(>50mg/dL),4)hyper
splenism about hemorrhage, hemolytic anemia, liver cirrhosis, 5)iron deficient anemia or being treated with iron, 6) a history of splenectomy, 7)being treated with antiplatelet agent about aspirin, 8)being treated with supplement contain vitamin C, 9)abnormal hemoglobinemia, 10)acute metabolic disturbance(diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, lactic acidosis, hypoglycemia) or sick day.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Tanaka
Organization st. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department if Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-Ku, Kawasaki, Kanagawa 216-8511, Japan.
TEL 044-977-8111
Email smu.tainai@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Fumiaki Matsubara
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-Ku, Kawasaki, Kanagawa 216-8511, Japan.
TEL 044-977-8111
Homepage URL
Email f2matsubara@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Arkray marketing Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 聖マリアンナ医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
2018 Year 09 Month 28 Day
Date of closure to data entry
2018 Year 10 Month 10 Day
Date trial data considered complete
2018 Year 10 Month 31 Day
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information Inpatients with diabetes wears a CGM for 3 days and have blood drawn.

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2018 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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