Type 2 Diabetes Mellitus With HypoglycemiaNCT02068300
The Role of 1.5-anhydro-D-glucitol as Clinical Biomarkers of Hypoglycemia in Patients With Diabetes
An observational study of Type 2 Diabetes Mellitus With Hypoglycemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus With Hypoglycemia
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- renal dysfunction patients
- hepatic dysfunction patients
- who has any kind of diseases, operations, medical treatments that can affect glucose levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1,5-Anhydro-D-Glucitol Can Reflect Hypoglycemia in Patients With Well Controlled Type 2 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
Read the 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.
- Keywords
- 1,5-anhydro-D-glucitol, hypoglycemia, surrogate marker
- Medical subject headings
- Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score
Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire.
Measured: 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.
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.
Measured: 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.
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.
Measured: within at least 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus With HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye Seung Jung, Seoul National University Hospital
- Investigators
- Hye Seung Jung, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068300
- Sponsor's protocol ID
- 1,5AG_Hypo
- Status last verified
- Apr 2016
- First submitted
- 19 Feb 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21688018
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1,5-Anhydro-D-Glucitol Can Reflect Hypoglycemia in Patients With Well Controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02068300
- Acronym / sponsor ID
- 1,5AG_Hypo
- Keywords
- 1,5-anhydro-D-glucitol, hypoglycemia, surrogate marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- renal dysfunction patients
- hepatic dysfunction patients
- who has any kind of diseases, operations, medical treatments that can affect glucose levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients.
Time frame: 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.
Time frame: within at least 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Results publication: PubMed 21688018Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hye Seung Jung, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus With Hypoglycemia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score (time frame: within the least 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.