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
1 other identifier
observational
51
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 15, 2016
April 1, 2016
2.3 years
February 19, 2014
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score
Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire.
within the least 3 months
Secondary Outcomes (2)
The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients.
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.
within at least 3months
Other Outcomes (1)
The plasma 1,5-anhydro-D-glucitol level may be a useful marker of daily glucose excursion in diabetes patients
24 hours
Eligibility Criteria
primary care clinic
You may qualify if:
- 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
You may not qualify if:
- renal dysfunction patients
- hepatic dysfunction patients
- who has any kind of diseases, operations, medical treatments that can affect glucose levels
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 21688018RESULT
Biospecimen
blood, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hye Seung Jung, MD
Seoul National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 21, 2014
Study Start
October 1, 2013
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share