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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02068300

Enrollment

Registered

2014-02-21

Start date

2013-10-31

Completion date

2016-03-31

Last updated

2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus With Hypoglycemia

Keywords

1,5-anhydro-D-glucitol, hypoglycemia, surrogate marker

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Other

Measure	Time frame
The plasma 1,5-anhydro-D-glucitol level may be a useful marker of daily glucose excursion in diabetes patients	24 hours

Countries

South Korea

Outcome results