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

N/ACompletedNCT02068300

Seoul National University Hospital51 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 2 Diabetes Mellitus With Hypoglycemia

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score

Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire.

Time frame: within the least 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: within at least 3months

Data from ClinicalTrials.gov

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