Impact of Pharmacy Clinic on Diabetes Management

Over the past 20 years, the number of adults with diabetes has tripled in the United States.
According to the Centers for Disease Control (CDC), diabetes mellitus (DM) affected 30.2
million American adults in 2015.

Previous studies showed that for each 1% reduction in hemoglobin A1c (HbA1c), there was a
corresponding 14% reduction in myocardial infarction, 12% reduction in stroke, and a 37%
reduction of microvascular complications.

Based on our preliminary data, a Pharmacist Managed Diabetes Clinic (PMDC) had a decrease in
HbA1c of 2.2% in the high-risk diabetes patients from the PMDC cohort versus 0.9% in the
standard care cohort (p=0.006). At six months there was a decrease in HbA1c of 3.2% in the
PMDC and 1.2% in the standard care cohort (p=0.044).

Our hypothesis is that a pharmacist managed diabetes clinic focused on patient identified
diabetes management gaps and goals would have a significant positive impact on diabetes core
measures and will result in a higher quality of care at a lower price. A randomized
controlled trial (RCT) of our PMDC would provide further clarity on the impact on patient
outcomes and important evidence with regard to how the physicians can deliver the best care
for this high-risk population.

Trial design This is a randomized open-label, controlled parallel group trial of a pharmacist
managed diabetes clinic in high-risk diabetes patients, with a 1:1 allocation to either
standard of care (SOC) or SOC and PMDC and a 6-month and 12-month follow-up.

Methods:

The study will be conducted at the listed recruiting sites at Beaumont Hospital. Michigan.
The outpatient clinic is a resident clinic that delivers medical care to over 920 patients
with diabetes mellitus. The clinic is based on campus at Beaumont Hospital, Royal Oak.
Potential subjects with high-risk diabetes mellitus will be identified through weekly reports
and from the daily schedule and will be recruited from this pool of patients exclusively.

Intervention The patients will be enrolled over a 6-month period and will be randomly
assigned to control group (usual care) and the intervention group (usual care plus PMDC
visits). The PMDC is a pharmacist-led clinic that has been functioning in our outpatient
clinic since January 2015 and is considered an available resource.

The intervention group patients will be managed by their assigned primary care physicians
(PCPs), per standard of care and will have scheduled six extra face-to-face visits with the
pharmacists for the 6 month duration of the intervention. The PMDC visits will be scheduled
more frequent in the first 2 months of the intervention to ensure patients' engagement and
provide enough opportunities and time to address all the patients' goals and concerns. The
PMDC visit encounters will focus on patient identified goals for the management of their
diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45
minutes. Patients will be asked to describe their own gaps in knowledge and to identify their
own management goals. Identification of knowledge gaps will allow targeted patient education
to close those gaps. Other educational opportunities will potentially include diabetes
mellitus pathophysiology, blood glucose goals, HbA1c goals, management of hyperglycemic and
hypoglycemic episodes, review of medications, and counseling regarding diet and exercise.
Pharmacists have the discretion to make medication adjustments and initiate new medications
pertinent to the management of diabetic comorbidities. The model is a collaborative practice
agreement between the pharmacist and the primary care physician.

The control group patients will be managed by their assigned PCPs, per standard of care.
Management per standard of care includes referrals to ophthalmology for dilated eye exam,
nephrology for nephropathy management, cardiology for macrovascular complications management,
neurology for neuropathy or neurologic complications, diabetic education, laboratory studies,
and vaccinations and will be ordered or performed at the discretion of each patient's PCP.

Outside the intervention, the participants in both groups will be treated identical. They
will participate in the standard of care visits at baseline, at 3 months and at 6 months.
These visits (visit 1, 6 and 9 in the intervention group and visit 1, 2 and 3 in the standard
of care group) will be provided by each patient's primary care physician

Inclusion Criteria:

- high risk diabetes mellitus type 2 patients (hemoglobin ≥ 9%)

- not currently enrolled in PMDC.

- established with a primary care resident internal medicine or medicine-pediatrics
resident.

- have a diagnosis of diabetes mellitus type 2.

Exclusion Criteria:

- Patients will be excluded if they have been seen by the PMDC within the past 3 months.

- under 18 years of age or over 75 years of age.

- documented as having type 1 diabetes or

- latent autoimmune diabetes of adults.