Trial Outcomes & Findings for Impact of Pharmacy Clinic on Diabetes Management (NCT NCT03377127)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

6 months

Results posted on

2021-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Of Care 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	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. 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
Overall Study STARTED	42	44
Overall Study COMPLETED	42	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Pharmacy Clinic on Diabetes Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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 n=86 Participants Total of all reporting groups
Age, Continuous	53.40 years STANDARD_DEVIATION 8.10 • n=99 Participants	52.00 years STANDARD_DEVIATION 9.67 • n=107 Participants	52.69 years STANDARD_DEVIATION 8.92 • n=206 Participants
Sex: Female, Male Female	26 Participants n=99 Participants	24 Participants n=107 Participants	50 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	20 Participants n=107 Participants	36 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	20 Participants n=99 Participants	26 Participants n=107 Participants	46 Participants n=206 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants	17 Participants n=107 Participants	38 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	42 participants n=99 Participants	44 participants n=107 Participants	86 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Data missing for 15 subjects, did not complete assessment.

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

Outcome measures

Outcome measures
Measure	Standard Of Care n=34 Participants 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	SOC and PMDC n=37 Participants 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
Hemoglobin A1c at 6 Months	-1.32 percentage of DCCT units Standard Deviation 1.66	-2.85 percentage of DCCT units Standard Deviation 2.69

PRIMARY outcome

Timeframe: 12 months

Population: Data missing for 25 subjects, did not complete assessment.

change from baseline in Hemoglobin A1c

Outcome measures

Outcome measures
Measure	Standard Of Care n=31 Participants 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	SOC and PMDC n=30 Participants 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
Hemoglobin A1c at 12 Months	-1.52 percentage of DCCT unit Standard Deviation 1.92	-2.79 percentage of DCCT unit Standard Deviation 2.41

SECONDARY outcome

Timeframe: 6 months

Population: Data missing for 15 subjects, did not complete assessment.

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

Outcome measures

Outcome measures
Measure	Standard Of Care n=34 Participants 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	SOC and PMDC n=37 Participants 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
Hemoglobin A1c Less Than 8% at 6 Months	10 Participants	21 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Data missing for 25 subjects, did not complete assessment.

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

Outcome measures

Outcome measures
Measure	Standard Of Care n=31 Participants 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	SOC and PMDC n=30 Participants 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
Hemoglobin A1c Less Than 8% at 12 Months	11 Participants	16 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

percentage of patients complying with annual lipid testing

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Achievement of Annual Lipid Panel Testing	24 Participants	26 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Statin Compliance	37 Participants	35 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Data missing for 23 subjects, did not complete assessment.

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

Outcome measures

Outcome measures
Measure	Standard Of Care n=31 Participants 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	SOC and PMDC n=32 Participants 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
Blood Pressure	26 Participants	21 Participants

SECONDARY outcome

Timeframe: 12 months

Percentage of patients compliant with annual retinopathy examination

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Annual Retinopathy Examination	25 Participants	25 Participants

SECONDARY outcome

Timeframe: 12 months

Percentage of patients compliant with annual nephropathy examination

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Annual Nephropathy Examination	30 Participants	26 Participants

SECONDARY outcome

Timeframe: 12 months

Percentage of patients compliant with annual neuropathy examination

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Annual Neuropathy Examination	30 Participants	29 Participants

SECONDARY outcome

Timeframe: 12 months

Percentage of patients compliant with annual influenza vaccine

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Annual Influenza Vaccine	21 Participants	20 Participants

SECONDARY outcome

Timeframe: 12 months

Percentage of patients compliant with annual pneumonia vaccine

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Annual Pneumonia Vaccine	31 Participants	27 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Data missing for 34 subjects, did not complete assessment.

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.

Outcome measures

Outcome measures
Measure	Standard Of Care n=29 Participants 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	SOC and PMDC n=23 Participants 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
Quality of Life Assessment	-0.31 score on a scale Standard Deviation 2.05	-0.78 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Diabetes Related EC Visits at 6 Months	0.10 number of visits Standard Deviation 0.37	0.00 number of visits Standard Deviation 0.00

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Diabetes Related EC Visits at 12 Months	0.12 number of visits Standard Deviation 0.40	0.02 number of visits Standard Deviation 0.15

SECONDARY outcome

Timeframe: 6 months

Number of Emergency Center (EC) visits

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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 EC Visits at 6 Months	0.62 number of visits Standard Deviation 0.99	0.68 number of visits Standard Deviation 1.12

SECONDARY outcome

Timeframe: 12 months

Number of Emergency Center (EC) visits

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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 EC Visits at 12 Months	1.05 number of visits Standard Deviation 1.29	1.09 number of visits Standard Deviation 1.65

SECONDARY outcome

Timeframe: 12 months

Total number of inpatient visits

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Inpatient Visits	0.71 number of visits Standard Deviation 1.94	0.73 number of visits Standard Deviation 1.13

SECONDARY outcome

Timeframe: 12 months

total number of outpatient visits

Outcome measures

Outcome measures
Measure	Standard Of Care n=42 Participants 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	SOC and PMDC n=44 Participants 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
Outpatient Visits	7.60 number of visits Standard Deviation 5.69	7.55 number of visits Standard Deviation 4.25

SECONDARY outcome

Timeframe: 12 months

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

percentage of visits missed in clinic

Outcome measures

Outcome data not reported

Adverse Events

Standard Of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SOC and PMDC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexandra Halalau

Beaumont Health

Phone: 2485513481

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place