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Glucose Control Using 1,5-AG Testing (GLUCAR)

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ClinicalTrials.gov Identifier: NCT03765164
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
GlycoMark, Inc
Information provided by (Responsible Party):
Qure Healthcare, LLC

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.


Condition or disease Intervention/treatment Phase
Diabetes Diagnostic Test: GlycoMark 1-5-AG Other: Clinical Performance and Value Vignettes Not Applicable

Detailed Description:

Nearly half of the adult population, 114 million Americans, are diagnosed with diabetes or pre-diabetes, making it one of the most important public and personal health problems. Diabetes is the 7th leading cause of death in America and a contributing factor in many more deaths and lost days of productivity. Its complications include vascular disease, cardiovascular disease, stroke and dementia. The cost of diabetes care and its complications lead to $176 billion in direct medical costs and $69 billion in reduced productivity. With an over 2-fold increase in diabetes prevalence in the past two decades and an estimated 1.5 million new cases expected annually, it is clinically and economically critical for this condition to be managed appropriately.

Diabetes treatment programs focus on controlling hyperglycemia (random glucose > 200 mg/dL) without causing hypoglycemia (glucose < 70 mg/dL). Glucose control is determined in a number of ways in current clinical practice. Immediate and fasting blood sugars are determined in routine chemistry tests. The standard measure of long-term diabetes control, HbA1c testing, provides a reliable reading of average blood glucose levels over a 2-3-month period. In patients with high HbA1c levels, HbA1c measurement guides management decisions and helps the clinician bring the long-term glucose levels under control in poorly controlled diabetic patients. Random blood sugars and HbA1c is limited in that they do not reflect glycemic control in intervals greater than the past few hours and 2-3 months. In particular, they do not provide an indication of frequent, temporary increases in blood glucose, termed glycemic excursions, which have been independently associated with several health complications. Since it takes months for HbA1c levels to stabilize, HbA1c levels are also not helpful for patients starting medication or changing drug therapy.

1,5-anhydroglucitol (1,5-AG) is a molecule found in the blood and is a validated indicator of glucose excursions and short-term (1-2 weeks) hyperglycemia. In healthy patients without diabetes, or those with well-controlled diabetes, 1,5-AG is maintained at a steady state in the blood. However, during glycemic excursions, the molecule is actively purged from the body through the urine. Cleared by the FDA in 2003, the GlycoMark assay measures 1,5-AG levels in the blood. Low levels of 1,5-AG indicate the presence of potentially harmful glycemic excursion over the last 1 to 2 weeks, which may have been missed during random blood glucose testing and not sensitively detected by HbA1c.

GlycoMark testing provides clinical details on peak glucose levels, daily spikes, and response to drugs, including short term effects, of hypoglycemic agents that are otherwise not available, giving physicians a more complete understanding of their patient's glycemic control. This information may be clinically useful to help physicians make better management decisions, improve diabetes outcomes, avoid complications and reduce unnecessary spending.

This study is a pre-post, two-round randomized controlled study of a nationally representative sample of primary care physicians randomly assigned to a control or intervention arm. Enrolled participants will be asked to care for a sample of CPV® simulated patients. The simulated patients are adults aged 18-75 who present with diabetes, different levels of glycemic control and various co-morbidities. Participants randomized into an intervention-arm will receive educational materials and 1,5-AG test results when caring for their patients in round 2. Investigators will assess the participants' ability to identify and address glycemic variability and hyperglycemia and evaluate whether physicians who have access to GlycoMark take steps to optimize glycemic control and reduce unnecessary resource utilization.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Glucose Control Using 1,5-AG: Randomized Controlled Trial
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
Active Comparator: Control
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
Simulated diabetic patients cared for online
Other Name: CPVs

Experimental: Intervention
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
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
Other Name: CPVs




Primary Outcome Measures :
  1. Diagnosis-Treatment [ Time Frame: 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.


Secondary Outcome Measures :
  1. Quality of care [ Time Frame: 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.

  2. Workup Costs [ Time Frame: 3 months ]
    Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765164


Contacts
Contact: John W Peabody, MD 4153213388 ext 1 jpeabody@qurehealthcare.com
Contact: MARY Tran, MS 4153213388 ext 1 mtran@qurehealthcare.com

Locations
United States, California
QURE Healthcare Recruiting
San Francisco, California, United States, 94109
Contact: John W Peabody, MD    415-321-3388 ext 1    jpeabody@qurehealthcare.com   
Contact: Mary T Tran, MS    4153213388 ext 1    mtran@qurehealthcare.com   
Principal Investigator: John W Peabody, MD         
Sponsors and Collaborators
Qure Healthcare, LLC
GlycoMark, Inc
Investigators
Study Director: Mary Tran, MS QURE Healthcare
Principal Investigator: John W Peabody, MD QURE Healthcare

Responsible Party: Qure Healthcare, LLC
ClinicalTrials.gov Identifier: NCT03765164     History of Changes
Other Study ID Numbers: Pro00024791
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No