PharmaMD: Impact of Pharmacy Clinic on Diabetes Management

• Sponsor: William Beaumont Hospitals (Other)
• Overall Status: Completed
• CT.gov ID: NCT03377127
• Collaborator: (none)
• Enrollment: 86
• Locations: 4
• Arms: 2
• Actual Duration (Months): 33.3
• Patients Per Site: 21.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The Beaumont Hospital Royal Oak Outpatient Clinic (and other listed Beaumont recruiting locations) care for over 900 patients with diabetes. In an effort to improve the care provided to our patients, a pharmacist managed diabetes clinic (PMDC) was created. The investigators looked at patients with high-risk diabetes who have received education in the PMDC and compared them to patients that didn't not receive the pharmacy education. Our preliminary data showed a significant decrease in Hemoglobin A1c in the PMDC compared to our standard care cohort. Hemoglobin A1c is a marker of the severity of diabetes mellitus. Based on this data, we designed a randomized controlled trial to better assess the impact of a PMDC on diabetic outcomes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Pharmacy Managed Diabetes Clinic (PMDC); Other: Standard of Care (SOC)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The patients and physicians will not be blinded to the intervention. However, the data collectors and the data analysts will be unaware of the patients allocation. The outcome assessors will also not be aware of the allocation. The biostatistician will also be blinded.
• Primary Purpose: Treatment
• Official Title: PHARM-MD; An Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
• Actual Study Start Date: Feb 19, 2018
• Actual Primary Completion Date: May 22, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care (SOC) The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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	Other: Standard of Care (SOC); Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Experimental: SOC and PMDC The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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.	Behavioral: Pharmacy Managed Diabetes Clinic (PMDC); 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.; Other: Standard of Care (SOC); Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1c at 6 Months [6 months]

   change from baseline in Hemoglobin A1c, measured in % DCCT (Diabetes Control and Complications Trial) units

2. Hemoglobin A1c at 12 Months [12 months]

   change from baseline in Hemoglobin A1c

Secondary Outcome Measures

1. Hemoglobin A1c Less Than 8% at 6 Months [6 months]

   Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0%

2. Hemoglobin A1c Less Than 8% at 12 Months [12 months]

   Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0% DCCT units

3. Change in Hemoglobin A1c From 6 to 12 Months [12 months]

   The change in hemoglobin A1c (HbA1c), between 6 months and 12 months after randomization.

4. Achievement of Annual Lipid Panel Testing [12 months]

   percentage of patients complying with annual lipid testing

5. Statin Compliance [12 months]

   Percentage of patients compliant with statin therapy per the 2013 American College of Cardiology / American Heart Association guidelines.

6. Blood Pressure [12 months]

   Percentage of patients achieving Blood pressure goal of less than 140/90 at the end of the trial period.

7. Annual Retinopathy Examination [12 months]

   Percentage of patients compliant with annual retinopathy examination

8. Annual Nephropathy Examination [12 months]

   Percentage of patients compliant with annual nephropathy examination

9. Annual Neuropathy Examination [12 months]

   Percentage of patients compliant with annual neuropathy examination

10. Annual Influenza Vaccine [12 months]

    Percentage of patients compliant with annual influenza vaccine

11. Annual Pneumonia Vaccine [12 months]

    Percentage of patients compliant with annual pneumonia vaccine

12. Quality of Life Assessment [12 months]

    Difference between quality of life assessment via the World Health Organization BREF-Quality Of Life at baseline and 12 months.The WHOQOL-BREF consists of 4 domains, Physical Health, Psychological, Social Relationships, and Environment. Each domain is comprised of multiple questions that are considered together in the derivation of each domain score. In addition to the 4 domains, the WHOQOL-BREF includes two stand-alone questions to assess rated QOL and Satisfaction with Health questionnaire administered at baseline and at the conclusion of the trial period. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) and range from a minimum of 4 to a maximum of 20. The mean score of items within each domain is used to calculate the domain score.A Likert scale from 1-7 was used. (1 - not affected, 7- extremely affected) We compared and reported the mean difference in between 6 months data and baseline data.

13. Diabetes Related EC Visits at 6 Months [6 months]

    Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia

14. Diabetes Related EC Visits at 12 Months [12 months]

    Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia

15. Total EC Visits at 6 Months [6 months]

    Number of Emergency Center (EC) visits

16. Total EC Visits at 12 Months [12 months]

    Number of Emergency Center (EC) visits

17. Inpatient Visits [12 months]

    Total number of inpatient visits

18. Outpatient Visits [12 months]

    total number of outpatient visits

19. No-show [12 months]

    percentage of visits missed in clinic

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Geriatric Assessment Center	Berkley	Michigan	United States	48072
2	Beaumont Outpatient Clinic	Royal Oak	Michigan	United States	48073
3	Beaumont Internal Medicine Center	Southfield	Michigan	United States	48034
4	Norton, Klein, Hug, Sabin and Maddens Internal Medicine & Primary Care Practice	Troy	Michigan	United States	48084

Sponsors and Collaborators

• William Beaumont Hospitals

Investigators

• Principal Investigator: Alexandra I Halalau, MD, Director of Internal Medicine Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 20, 2020
• Informed Consent Form - Feb 7, 2019

More Information

Publications

None provided.

• Responsible Party: Alexandra Halalau, Director of Internal Medicine Research, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT03377127
• Other Study ID Numbers: 2017-494
• First Posted: Dec 19, 2017
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 1, 2021

• 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: No
• Keywords provided by Alexandra Halalau, Director of Internal Medicine Research, William Beaumont Hospitals: diabetes; pharmacy clinic; education; diabetes complications; hemoglobin A1c; health-care cost; 'no show' rate; compliance; diabetes core measures
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Period Title: Overall Study
STARTED	42	44
COMPLETED	42	44
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard Of Care	SOC and PMDC	Total
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	Total of all reporting groups
Overall Participants	42	44	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.40 (8.10)	52.00 (9.67)	52.69 (8.92)
Sex: Female, Male (Count of Participants)
Female	26 61.9%	24 54.5%	50 58.1%
Male	16 38.1%	20 45.5%	36 41.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	20 47.6%	26 59.1%	46 53.5%
White	21 50%	17 38.6%	38 44.2%
More than one race	1 2.4%	1 2.3%	2 2.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	42 100%	44 100%	86 100%

Outcome Measures

1. Primary Outcome

Title	Hemoglobin A1c at 6 Months
Description	change from baseline in Hemoglobin A1c, measured in % DCCT (Diabetes Control and Complications Trial) units
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data missing for 15 subjects, did not complete assessment.

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	34	37
Mean (Standard Deviation) [percentage of DCCT units]	-1.32 (1.66)	-2.85 (2.69)

2. Primary Outcome

Title	Hemoglobin A1c at 12 Months
Description	change from baseline in Hemoglobin A1c
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data missing for 25 subjects, did not complete assessment.

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	31	30
Mean (Standard Deviation) [percentage of DCCT unit]	-1.52 (1.92)	-2.79 (2.41)

3. Secondary Outcome

Title	Hemoglobin A1c Less Than 8% at 6 Months
Description	Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0%
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data missing for 15 subjects, did not complete assessment.

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	34	37
Count of Participants [Participants]	10 23.8%	21 47.7%

4. Secondary Outcome

Title	Hemoglobin A1c Less Than 8% at 12 Months
Description	Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0% DCCT units
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data missing for 25 subjects, did not complete assessment.

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	31	30
Count of Participants [Participants]	11 26.2%	16 36.4%

5. Secondary Outcome

Title	Change in Hemoglobin A1c From 6 to 12 Months
Description	The change in hemoglobin A1c (HbA1c), between 6 months and 12 months after randomization.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

data were not collected or analyzed for this outcome for any participant

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	0	0

6. Secondary Outcome

Title	Achievement of Annual Lipid Panel Testing
Description	percentage of patients complying with annual lipid testing
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Count of Participants [Participants]	24 57.1%	26 59.1%

7. Secondary Outcome

Title	Statin Compliance
Description	Percentage of patients compliant with statin therapy per the 2013 American College of Cardiology / American Heart Association guidelines.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Count of Participants [Participants]	37 88.1%	35 79.5%

8. Secondary Outcome

Title	Blood Pressure
Description	Percentage of patients achieving Blood pressure goal of less than 140/90 at the end of the trial period.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data missing for 23 subjects, did not complete assessment.

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	31	32
Count of Participants [Participants]	26 61.9%	21 47.7%

9. Secondary Outcome

Title	Annual Retinopathy Examination
Description	Percentage of patients compliant with annual retinopathy examination
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Count of Participants [Participants]	25 59.5%	25 56.8%

10. Secondary Outcome

Title	Annual Nephropathy Examination
Description	Percentage of patients compliant with annual nephropathy examination
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Count of Participants [Participants]	30 71.4%	26 59.1%

11. Secondary Outcome

Title	Annual Neuropathy Examination
Description	Percentage of patients compliant with annual neuropathy examination
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Count of Participants [Participants]	30 71.4%	29 65.9%

12. Secondary Outcome

Title	Annual Influenza Vaccine
Description	Percentage of patients compliant with annual influenza vaccine
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Count of Participants [Participants]	21 50%	20 45.5%

13. Secondary Outcome

Title	Annual Pneumonia Vaccine
Description	Percentage of patients compliant with annual pneumonia vaccine
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Count of Participants [Participants]	31 73.8%	27 61.4%

14. Secondary Outcome

Title	Quality of Life Assessment
Description	Difference between quality of life assessment via the World Health Organization BREF-Quality Of Life at baseline and 12 months.The WHOQOL-BREF consists of 4 domains, Physical Health, Psychological, Social Relationships, and Environment. Each domain is comprised of multiple questions that are considered together in the derivation of each domain score. In addition to the 4 domains, the WHOQOL-BREF includes two stand-alone questions to assess rated QOL and Satisfaction with Health questionnaire administered at baseline and at the conclusion of the trial period. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) and range from a minimum of 4 to a maximum of 20. The mean score of items within each domain is used to calculate the domain score.A Likert scale from 1-7 was used. (1 - not affected, 7- extremely affected) We compared and reported the mean difference in between 6 months data and baseline data.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Data missing for 34 subjects, did not complete assessment.

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	29	23
Mean (Standard Deviation) [score on a scale]	-0.31 (2.05)	-0.78 (2.07)

15. Secondary Outcome

Title	Diabetes Related EC Visits at 6 Months
Description	Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Mean (Standard Deviation) [number of visits]	0.10 (0.37)	0.00 (0.00)

16. Secondary Outcome

Title	Diabetes Related EC Visits at 12 Months
Description	Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Mean (Standard Deviation) [number of visits]	0.12 (0.40)	0.02 (0.15)

17. Secondary Outcome

Title	Total EC Visits at 6 Months
Description	Number of Emergency Center (EC) visits
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Mean (Standard Deviation) [number of visits]	0.62 (0.99)	0.68 (1.12)

18. Secondary Outcome

Title	Total EC Visits at 12 Months
Description	Number of Emergency Center (EC) visits
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Mean (Standard Deviation) [number of visits]	1.05 (1.29)	1.09 (1.65)

19. Secondary Outcome

Title	Inpatient Visits
Description	Total number of inpatient visits
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Mean (Standard Deviation) [number of visits]	0.71 (1.94)	0.73 (1.13)

20. Secondary Outcome

Title	Outpatient Visits
Description	total number of outpatient visits
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	42	44
Mean (Standard Deviation) [number of visits]	7.60 (5.69)	7.55 (4.25)

21. Secondary Outcome

Title	No-show
Description	percentage of visits missed in clinic
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

data were not collected or analyzed for this outcome for any participant

Arm/Group Title	Standard Of Care	SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations	The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Measure Participants	0	0

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Arm/Group Title	Standard Of Care		SOC and PMDC
Arm/Group Description	The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. 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 Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations		The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. 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. Pharmacy Managed Diabetes Clinic (PMDC): 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. Standard of Care (SOC): Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
All Cause Mortality
	Standard Of Care		SOC and PMDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Standard Of Care		SOC and PMDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Standard Of Care		SOC and PMDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

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.