Best Evidence Analyses and Commentary

Summarizing the Revisions made in the 2014 ADA Standards of Care
Alexander D. Covey, PharmD Candidate; Marcus Campbell, PharmD, BC-ADM

Diabetes is a complex chronic disease that requires constant management from both patients and practitioners . Since its founding in 1940, the American Diabetes Association (ADA) has been a leader in promoting research and compiling clinical data for the treatment of diabetes. In order to keep up with the fast pace of medical science, the ADA publishes an annual revision of its Standards of Care. With the exception of major drug advances or groundbreaking clinical data, the guidelines do not typically change dramatically from year to year. However, the subtle changes made over time accumulate to form a finely tuned disease management algorithm. It is therefore critically important that healthcare providers keep up to date on this information to best serve their patients. Below is a summary of the changes made for the 2014 ADA Standards of Care.1

Screening and Diagnosis

The 2014 guidelines include data from a study published in JAMA in 2013 that looked at the rate of progression to type 1 diabetes in children who had seroconversion of islet autoantibodies.2 The study found that children who had seroconversion with multiple autoantibodies had risks of 70% and 84% of developing type 1 diabetes within 10 and 15 years, respectively. This is notable because the data was pooled from cohorts of children from 3 different countries who had a first degree relative with type 1 diabetes, lending evidence to support screening in patients who have a first degree relative with type 1 diabetes. There are currently no accepted screening programs for this type of patient, but the ADA recommends having them screened in a clinical trial setting.1

Detection and Diagnosis of Gestational Diabetes: There has been some debate about the diagnostic criteria for gestational diabetes mellitus (GDM). As a result of the HAPO study, the 2011 ADA Standards of Care began recommending a “One-step” diagnostic approach wherein all pregnant patients without prior diabetes diagnoses should undergo a 2 hour 75gm oral glucose tolerance test (OGTT) at 24-28 weeks of gestation.3 The threshold for diagnosis of GDM with this method was based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and anticipated an increase in the prevalence of GDM from 5-6% to 15-20%. The burdens of this increased prevalence of GDM were thought to be justified by improved pregnancy outcomes for both mothers and offspring, although there was an admitted lack of clinical data to substantiate this claim.

In 2013, the National Institutes of Health (NIH) completed a consensus development conference to address the IADPSG recommendations. After reviewing the available data, the NIH recommended continuation of the “two-step” diagnostic approach that had previously been the standard. The decision was based on the lack of clinical data to support the one-step method, as well as the concern for the negative effects of identifying a large new group of patients with GDM under the IADPSG recommendations. The ADA 2014 Standards of Care still include the one-step approach as an option, but there is clear language that more evidence is needed to determine the superiority of one method over the other.1

Drug Therapy

Pharmacologic Therapy for Hyperglycemia in Type 2 Diabetes: Monotherapy with metformin is the recommended first step in managing a type 2 diabetic if they are eligible for non-insulin therapy and do not have any contraindications. It was previously recommended that monotherapy be administered for 3-6 months to achieve goal A1C levels, and failure would indicate adding a second agent. The 2014 standards of care have cut the time frame for monotherapy to 3 months if A1C goals are not achieved.1

Antiplatelet Agents: Patients who had experienced an ACS were previously recommended to use clopidogrel as an adjunct or alternative to aspirin for a year after their event to reduce the risk of future CVD events. The 2014 guidelines have changed the language to reflect more recent evidence that suggests dual therapy with a P2Y12 inhibitor in addition to aspirin can reduce future CVD events. Specifically, clopidogrel or ticagrelor should be used if no percutaneous coronary intervention (PCI) was performed, and clopidogrel, ticagrelor, or prasugrel could be used if PCI was performed.

Neuropathy: In previous guidelines, the treatment options were fairly vague and mostly pointed the reader to other sources of information. The 2014 guidelines revised this section to include a much more detailed discussion of the treatment options for specific types of neuropathy including: distal symmetric polyneuropathy, autonomic neuropathy, orthostatic hypotension, gastroparesis, and erectile dysfunction. The new subsections include discussions of the challenges, goals, and specific drugs or strategies used to treat the respective neuropathy.

Diabetes Care in the Hospital: The sole use of sliding scale insulin regimens has previously been frowned upon by the ADA with clinical evidence that demonstrates increased risks of hyper and hypoglycemia, as well as adverse outcomes for general surgery patients. In the 2014 guidelines, the ADA uses very direct language to strongly discourage the sole use of sliding scale insulin for glycemic control of any type of diabetic. The preferred method is to take a more physiological approach that includes basal, prandial, and correctional insulin.1

Monitoring

Glucose Monitoring: There was a small change to this section due to recent FDA approval of a sensor augmented insulin pump device equipped with an automatic low glucose suspend feature. These pumps are used as a tool for continuous glucose monitoring (CGM) which has been shown to be particularly beneficial to patients who have hypoglycemic unawareness. The ASPIRE trial looked at 247 patients who used augmented insulin pumps with the suspend feature and found that patients older than 16 had significantly reduced nocturnal hypoglycemic episodes without significantly increasing A1C levels. CGM devices with the suspend feature are useful for preventing severe hypoglycemic events in patients with nocturnal hypoglycemia, but more data and standardization is needed before CGM will be widely recommended to all insulin dependent diabetics.

Retinopathy: Previous guidelines both type 1 and type 2 patients who had normal eye exams should have repeat eye exams annually, but that could be extended to 2-3 years at the provider’s discretion. The 2014 guidelines now recommend the maximum time between eye exams should be 2 years.1

Miscellaneous

Diabetes Care in Special Populations: This section was updated with information recently published by the CDC, including their projections of prevalence for type 2 diabetes using the SEARCH database. If the current trend of increased diagnosis continues, the number of type 2 diabetics under the age of 20 in the United States is due to quadruple in the next 40 years. This information is particularly disturbing because distinguishing type 1 from type 2 diabetes in patients this young can be difficult, but is critical in determining the best treatment options.1


1. American Diabetes Association. Standards of Medical Care in Diabetes—2014 Diabetes Care. January 2014;37:Supplement 1 S14-S80; doi:10.2337/dc14-S014 1935-5548.Retrieved: http://care.diabetesjournals.org/content/37/Supplement_1/S14.full.pdf+html

2. Ziegler AG, Rewers M, Simell O, et al. Seroconversion to multiple islet autoantibodies and risk of progression to diabetes in children. JAMA. 2013;309(23):2473-2479.

3. American Diabetes Association. Standards of Medical Care in Diabetes—2011. Diabetes Care. January 2011;34: Supplement 1 S11-S61 http://care.diabetesjournals.org/content/34/Supplement_1/S11.full


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