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Completed

NCT Number: NCT02068300

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus With Hypoglycemia Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: within the least 3 months

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

Secondary outcomes

  1. The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients.

    Time frame: 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.

  2. The relation between glycemic variability indices such as MAGE of continuous glucose monitoring system and 1,5-AG in insulin using patients.

    Time frame: 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 outcomes

  1. The plasma 1,5-anhydro-D-glucitol level may be a useful marker of daily glucose excursion in diabetes patients

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2014
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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