NCT03765164: GLUCAR

Glucose Control Using 1,5-AG Testing

Completed NA Results posted Last updated 28 October 2020

What this trial tests

NA trial testing GlycoMark 1-5-AG in Diabetes in 156 participants. Completed in 24 February 2019.

Timeline

5 November 2018

Primary endpoint
24 February 2019

24 February 2019

Quick facts

Lead sponsor	Qure Healthcare, LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	156
Start date	5 November 2018
Primary completion	24 February 2019
Estimated completion	24 February 2019
Sites	1 location across United States

Drugs / interventions tested

• GlycoMark 1-5-AG
• Clinical Performance and Value Vignettes

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

Qure Healthcare, LLC — full company profile →

Who can join

Eligibility, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnosis-Treatment Primary · 3 months

Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.

Round 2

Group	Value	95% CI
Control	31.7	± 13.4
Intervention	35.0	± 15.0

Round 1

Group	Value	95% CI
Control	29.1	± 12.3
Intervention	31.9	± 12.2

Quality of Care Secondary · 3 months

Difference-in-differences regression analysis between the control and the intervention group's overall quality of care scores. In each CPV case, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each case.

Round 2

Group	Value	95% CI
Control	51.4	± 11.1
Intervention	52.1	± 12.3

Round 1

Group	Value	95% CI
Control	50.9	± 10.0
Intervention	48.9	± 10.8

Workup Costs Secondary · 3 months

Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.

Round 2

Group	Value	95% CI
Control	78	± 156
Intervention	37	± 87

Round 1

Group	Value	95% CI
Control	54	± 100
Intervention	60	± 116

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Variation in Diabetes Management: A National Assessment of Primary Care Providers.
   Peabody JW, de Belen E, Dahlen JR, Acelajado MC, et al · · 2020 · cited 3× · PMID 31282183 · DOI 10.1177/1932296819861662
2. Finding the clinical utility of 1,5-anhydroglucitol among primary care practitioners.
   Peabody J, Paculdo D, Acelajado MC, Burgon T, et al · · 2020 · cited 2× · PMID 32368501 · DOI 10.1016/j.jcte.2020.100224