Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03765164 |
| Other study ID # |
Pro00024791 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2018 |
| Est. completion date |
February 24, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Qure Healthcare, LLC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
