N/A
Completed N=86
Impact of Pharmacy Clinic on Diabetes Management
Source: ClinicalTrials.gov NCT03377127 ↗Enrolled (actual)
86
Serious AEs
—
Results posted
Jun 2021
Primary outcomePrimary: Hemoglobin A1c at 6 Months — -1.32; -2.85 percentage of DCCT units
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c at 6 Months |
-1.32; -2.85 | — |
| PRIMARY Hemoglobin A1c at 12 Months |
-1.52; -2.79 | — |
| SECONDARY Hemoglobin A1c Less Than 8% at 6 Months |
10; 21 | — |
| SECONDARY Hemoglobin A1c Less Than 8% at 12 Months |
11; 16 | — |
| SECONDARY Change in Hemoglobin A1c From 6 to 12 Months |
— | — |
| SECONDARY Achievement of Annual Lipid Panel Testing |
24; 26 | — |
| SECONDARY Statin Compliance |
37; 35 | — |
| SECONDARY Blood Pressure |
26; 21 | — |
| SECONDARY Annual Retinopathy Examination |
25; 25 | — |
| SECONDARY Annual Nephropathy Examination |
30; 26 | — |
| SECONDARY Annual Neuropathy Examination |
30; 29 | — |
| SECONDARY Annual Influenza Vaccine |
21; 20 | — |
| SECONDARY Annual Pneumonia Vaccine |
31; 27 | — |
| SECONDARY Quality of Life Assessment |
-0.31; -0.78 | — |
| SECONDARY Diabetes Related EC Visits at 6 Months |
0.10; 0.00 | — |
| SECONDARY Diabetes Related EC Visits at 12 Months |
0.12; 0.02 | — |
| SECONDARY Total EC Visits at 6 Months |
0.62; 0.68 | — |
| SECONDARY Total EC Visits at 12 Months |
1.05; 1.09 | — |
| SECONDARY Inpatient Visits |
0.71; 0.73 | — |
| SECONDARY Outpatient Visits |
7.60; 7.55 | — |
| SECONDARY No-show |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03377127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.