UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between glucose variability evaluated by CGMS and labile hemoglobin A1c measured by high performance liquid chromatography (HPLC) in Japanese patients with diabetes.
Title of the study (Brief title)	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	Yasushi Tanaka
Organization	st. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department if Internal Medicine
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	Fumiaki Matsubara
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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