N/A
N=156
Glucose Control Using 1,5-AG Testing
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03765164 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Diagnosis-Treatment — 31.7; 35.0; 29.1; 31.9 CPV diagnosis-treatment percentage score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GlycoMark 1-5-AG (Diagnostic_test); Clinical Performance and Value Vignettes (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Qure Healthcare, LLC
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnosis-Treatment |
31.7; 35.0; 29.1; 31.9 | — |
| SECONDARY Quality of Care |
51.4; 52.1; 50.9; 48.9 | — |
| SECONDARY Workup Costs |
78; 37; 54; 60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- A minimum of 2 years post residency but no more than 30 years in practice
- Board-certified in internal medicine or family practice, primary care physicians
- In a private solo or multi-group practice
- Minimum threshold of patients (40+) currently seen weekly
- A minimum of 15% of their panel under their care for diabetes
- Have not used GlycoMark assay in the past
- Informed, signed and voluntarily consented to be in the study
Exclusion Criteria
- Not board certified in their respective area of care
- Academic-based practice
- Have practiced as a board-certified physician for less than 2 or greater than 30 years
- Have used the GlycoMark assay
- Follow <40 patients weekly
- < 15% of their patient panel under their care for diabetes
- Non-English speaking
- Unable to access the internet
Data sourced from ClinicalTrials.gov (NCT03765164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.