Clinical trial NCT02068300: The Role of 1.5-anhydro-D-glucitol as Clinical Biomarkers of Hypoglycemia in Patients With Diabetes
Official title: 1,5-Anhydro-D-Glucitol Can Reflect Hypoglycemia in Patients With Well Controlled Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus With Hypoglycemia
Keywords: 1,5-anhydro-D-glucitol, hypoglycemia, surrogate marker
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score
timeFrame: within the least 3 months
Secondary outcomes:
measure: The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients.
timeFrame: within at leat 3months
measure: The relation between glycemic variability indices such as MAGE of continuous glucose monitoring system and 1,5-AG in insulin using patients.
timeFrame: within at least 3months
Other outcomes:
measure: The plasma 1,5-anhydro-D-glucitol level may be a useful marker of daily glucose excursion in diabetes patients
timeFrame: 24 hours
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hye Seung Jung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MJ, Jung HS, Hwang-Bo Y, Cho SW, Jang HC, Kim SY, Park KS. Evaluation of 1,5-anhydroglucitol as a marker for glycemic variability in patients with type 2 diabetes mellitus. Acta Diabetol. 2013 Aug;50(4):505-10. doi: 10.1007/s00592-011-0302-0. Epub 2011 Jun 18.