GLUCAR: Glucose Control Using 1,5-AG Testing

• Sponsor: Qure Healthcare, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03765164
• Collaborator: GlycoMark, Inc (Other)
• Enrollment: 156
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 42.8

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 156 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.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: Nov 5, 2018
• Actual Primary Completion Date: Feb 24, 2019
• Actual Study Completion Date: Feb 24, 2019

Arms and Interventions

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 Names: 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 Names: CPVs

Outcome Measures

Primary Outcome Measures

1. Diagnosis-Treatment [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 [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 [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QURE Healthcare	San Francisco	California	United States	94109

Sponsors and Collaborators

• Qure Healthcare, LLC
• GlycoMark, Inc

Investigators

• Study Director: Mary Tran, MS, QURE Healthcare
• Principal Investigator: John W Peabody, MD, QURE Healthcare

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 14, 2018

More Information

Publications

None provided.

• Responsible Party: Qure Healthcare, LLC
• ClinicalTrials.gov Identifier: NCT03765164
• Other Study ID Numbers: Pro00024791
• First Posted: Dec 5, 2018
• Last Update Posted: Oct 28, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Control	Intervention
Arm/Group Description	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. Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online	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. GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
Period Title: Pre-intervention
STARTED	78	78
COMPLETED	73	72
NOT COMPLETED	5	6
Period Title: Pre-intervention
STARTED	73	72
COMPLETED	0	0
NOT COMPLETED	73	72

Baseline Characteristics

Arm/Group Title	Control	Intervention	Total
Arm/Group Description	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. Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online	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. GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online	Total of all reporting groups
Overall Participants	73	72	145
Age, Customized (Count of Participants)
<40	5 6.8%	3 4.2%	8 5.5%
40-55	45 61.6%	42 58.3%	87 60%
>55	23 31.5%	27 37.5%	50 34.5%
Sex: Female, Male (Count of Participants)
Female	11 15.1%	18 25%	29 20%
Male	62 84.9%	54 75%	116 80%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Practice locale (urban, suburban, or rural) (Count of Participants)
Urban	14 19.2%	24 33.3%	38 26.2%
Suburban	45 61.6%	33 45.8%	78 53.8%
Rural	14 19.2%	15 20.8%	29 20%
U.S. Region Location of Practice (Count of Participants)
Midwest	20 27.4%	13 18.1%	33 22.8%
Northeast	17 23.3%	13 18.1%	30 20.7%
South	22 30.1%	30 41.7%	52 35.9%
West	14 19.2%	16 22.2%	30 20.7%

Outcome Measures

1. Primary Outcome

Title	Diagnosis-Treatment
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	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. Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online	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. GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
Measure Participants	73	72
Round 2	31.7 (13.4)	35.0 (15.0)
Round 1	29.1 (12.3)	31.9 (12.2)

2. Secondary Outcome

Title	Quality of Care
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	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. Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online	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. GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
Measure Participants	73	72
Round 2	51.4 (11.1)	52.1 (12.3)
Round 1	50.9 (10.0)	48.9 (10.8)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	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. Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online	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. GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
Measure Participants	73	72
Round 2	78 (156)	37 (87)
Round 1	54 (100)	60 (116)

Adverse Events

Time Frame	3 months
Arm/Group Title	Control		Intervention
Arm/Group Description	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. Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online		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. GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online
All Cause Mortality
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/72 (0%)
Serious Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/72 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.