The Role of 1.5-anhydro-D-glucitol as Clinical Biomarkers of Hypoglycemia in Patients With Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-D-glucitol (1,5-AG) as a novel surrogate marker of hypoglycemia

Detailed Description
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We enrolled well controlled diabetes patients who had hypoglycemic event at least one time more. All patients assess the risk of severe hypoglycemia and hypoglycemic unawareness using hypoglycemic awareness questionnaires (HYPO score). The patients who are treated with insulin agent were inserted sensor of continuous glucose monitoring systems under the skin during three days. We were analysed the correlation between 1,5-anhydro-D-glucitol and HYPO score.

Official Title
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1,5-Anhydro-D-Glucitol Can Reflect Hypoglycemia in Patients With Well Controlled Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus With Hypoglycemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients attending outpatients of department of endocrinology and metabolism, seoul national university hospital .(HbA1C <8%) The patients who treated with insulin or sulfonylureas at least 3month period In case fo sulfonylurea user, HbA1c was restricted under 8% The patients who had hypoglycemic event at least 3 months who has can be survey questionnaire who can insert continuous glucose monitoring system Exclusion Criteria: renal dysfunction patients hepatic dysfunction patients who has any kind of diseases, operations, medical treatments that can affect glucose levels
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score | Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire. | within the least 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients. | Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire. Continuous glucose monitoring system was performed to find hypoglycemic event and glycemic variability in insulin using patients. | within at leat 3months | 
| The relation between glycemic variability indices such as MAGE of continuous glucose monitoring system and 1,5-AG in insulin using patients. | 1,5-AG was measured from patient's serum. Continuous glucose monitoring system was performed to find hypoglycemic event and glycemic variability in insulin using patients. | within at least 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1,5-anhydro-D-glucitol, hypoglycemia, surrogate marker