UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030696
Receipt number 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 13:53:55

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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 or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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