Glucose Control Using 1,5-AG Testing

NCT03765164 | Completed Results DMC FDA Device

• 1 other identifier: Pro00024791
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes

Outcome Measures

Primary Outcomes (1)

• Diagnosis-Treatment

  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.

  3 months

Secondary Outcomes (2)

• Quality of Care

  3 months

• Workup Costs

  3 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.

Other: Clinical Performance and Value Vignettes

Intervention

EXPERIMENTAL

Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.

Diagnostic Test: GlycoMark 1-5-AG; Other: Clinical Performance and Value Vignettes

Interventions

GlycoMark 1-5-AG DIAGNOSTIC_TEST

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

Intervention

Clinical Performance and Value Vignettes OTHER

Simulated diabetic patients cared for online

Also known as: CPVs

Control; Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• GlycoMark, Inc.: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: QURE Healthcare

qureadmin@qurehealthcare.com

415-321-3388

Study Officials

• Mary Tran, MS

  QURE Healthcare

  STUDY DIRECTOR

• John W Peabody, MD

  QURE Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a pre-post, two-round, randomized controlled study of a nationally representative sample of primary care physicians, including internists and family physicians, randomly assigned to a control or intervention arm. Once eligibility is determined and providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background. They will then care for a total of 6 CPV® simulated patients over the two rounds (3 per round). The simulated patients are adults aged 18-75 who present with diabetes, different levels of glycemic control and various co-morbidities. The study design consists of two study arms, a control arm and an intervention-arm that receives educational materials and the 1,5-AG results.

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: November 5, 2018
• Primary Completion: February 24, 2019
• Study Completion: February 24, 2019
• Last Updated: October 28, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)