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

Completed

• Conditions: Type 2 Diabetes Mellitus With Hypoglycemia

• Registration Number: NCT02068300
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

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Exclusion Criteria

• renal dysfunction patients
• hepatic dysfunction patients
• who has any kind of diseases, operations, medical treatments that can affect glucose levels

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The relation between glycemic variability indices such as MAGE of continuous glucose monitoring system and 1,5-AG in insulin using patients.	within at least 3months	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.
The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients.	within at leat 3months	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of