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Glucose Control Using 1,5-AG Testing

NCT03765164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2020-10-28

Study results available
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Summary

Glycemic excursions (temporary increases in blood glucose) are associated with health complications. Standard tests for diabetes (e.g. random blood sugar and HbA1c) do not test for these excursions despite their association with several health complications. GlycoMark's 1,5-anhydroglucitol (1,5-AG) is a validated indicator of glucose excursions in addition to short-term (1-2 weeks) hyperglycemia.

This study is a pre-post, two-round randomized controlled study of a nationally representative sample of primary care physicians. Investigators will assess whether physician participants are able to identify and address glycemic variability and hyperglycemia in their patients and, when given access to GlycoMark assay results, improve their patient management decisions by taking steps to optimize glycemic control, and reduce unnecessary resource utilization.

Conditions

Interventions

DIAGNOSTIC_TEST

GlycoMark 1-5-AG

Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients

OTHER

Clinical Performance and Value Vignettes

Simulated diabetic patients cared for online

Sponsors & Collaborators

  • GlycoMark, Inc.

    collaborator INDUSTRY

  • Qure Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • Mary Tran, MS · QURE Healthcare

  • John W Peabody, MD · QURE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-02-24
Completion
2019-02-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03765164 on ClinicalTrials.gov