Pharmacist-Led Care for Diabetes

Overseen By Renee Woodard

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Sulfonylureas, Insulin

Disqualifiers: Hearing loss, Alzheimer's, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pharmacist involvement in diabetes management can enhance care for older adults. Participants will collaborate with a pharmacist who works with their doctor to adjust medications and achieve recommended diabetes levels. This pharmacist-led optimization intervention suits those with Type 2 Diabetes who have used medications like insulin or sulfonylureas and are part of Atrium Health Wake Forest Baptist. Participants should also have manageable hearing and speak English, as follow-ups occur over the phone. As an unphased trial, this study allows participants to contribute to innovative diabetes care strategies and potentially improve their own health management.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it involves potentially adjusting your diabetes medications to meet guidelines. It's best to discuss this with the trial team.

What prior data suggests that this pharmacist-led diabetes management program is safe for older adults?

Research has shown that involving pharmacists in diabetes care is generally safe and very helpful. Studies indicate that this approach can improve blood sugar control, enhance medication adherence, and increase understanding of diabetes.

For instance, one study found that when pharmacists participated, cholesterol levels decreased and medication adherence improved. Another study demonstrated that these interventions enhanced people's knowledge about diabetes and their self-management abilities. Importantly, these benefits occurred without reports of serious side effects, suggesting that this care is well-tolerated.

Overall, research suggests that pharmacist-led care is a safe and effective way to manage diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pharmacist-Led Optimization Intervention for diabetes because it offers a personalized and proactive approach to managing Type 2 Diabetes Mellitus (T2DM). Unlike standard treatments, which typically involve regular doctor visits and medication adjustments, this method involves direct interactions with pharmacists who provide tailored advice and adjustments through face-to-face or telehealth appointments. This hands-on management can help patients reach target glucose levels more effectively, potentially leading to better overall control of their diabetes. This approach emphasizes patient education and engagement, which might improve adherence to treatment and lifestyle changes.

What evidence suggests that this pharmacist-led optimization intervention is effective for diabetes care?

Research has shown that pharmacist-led care programs can greatly improve diabetes management. In this trial, participants in the Active Intervention arm will receive pharmacist-led care, which includes information about Type 2 Diabetes Mellitus (T2DM) guidelines and up to three pharmacist visits. Studies have found that such programs help lower bad cholesterol, triglycerides, and overall cholesterol levels in people with type 2 diabetes. They also help patients adhere to their medication schedules, ensuring they take their medicine as directed. Additionally, these programs help control blood sugar levels, which is essential for managing diabetes. Other benefits include increased understanding of diabetes and a better quality of life for patients. Overall, pharmacist-led care has proven effective in improving health outcomes for people with diabetes. ^{1 2 3 4 5}

Who Is on the Research Team?

Kathryn E. Callahan, MD

Principal Investigator

Atrium Health Wake Forest Baptist Health

Are You a Good Fit for This Trial?

This trial is for older adults with Type 2 Diabetes who are taking certain diabetes medications, have had a specific level of blood sugar control in the past two years, and can communicate in English by phone. They must be part of a specific healthcare organization and not have severe hearing loss or dementia.

Inclusion Criteria

Your average blood sugar level (HbA1c) has been less than 7.5% in the last 2 years.

Attributed to a Atrium Health Wake Forest Baptist-affiliated Accountable Care Organization

I am currently using insulin or sulfonylurea for my Type 2 Diabetes.

Exclusion Criteria

I have been diagnosed with Alzheimer's disease or related dementia.

I do not have a phone number for follow-up contacts.

You have significant difficulty hearing (due to phone calls).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a pharmacist-led diabetes management program, including up to 3 visits to adjust diabetes medications to meet ADA guidelines

3 months

Up to 3 visits (in-person or telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on achieving target glucose levels and guideline-concordant medical therapy

6-12 months

Month 6 follow-up

Long-term Follow-up

Participants' outcomes, including mortality and hypoglycemic events, are tracked through EHR and NC death registry

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist-Led Optimization Intervention

Trial Overview The study tests if a pharmacist-led program can improve diabetes care for older adults by adjusting their medication to meet guidelines. Participants will work with pharmacists alongside their doctors and undergo routine bloodwork as part of the management program.

How Is the Trial Designed?

Group I: Active Intervention Experimental Treatment 1 Intervention

Subjects are mailed Information about Type 2 Diabetes Mellitus (T2DM) Guidelines and Appointment Information (Face to face \[F2F\] or Telehealth). They attend up to 3 pharmacist visits, depending on if they reach target glucose levels. And they attend interviews. They also have month 6 follow up.

Group II: Active Decliners Active Control 1 Intervention

Subjects who decline intervention. Standard of care treatment with month 6 follow up.

Group III: Control Active Control 1 Intervention

Subjects in this arm will receive standard of care treatment with no intervention. They will receive month 6 follow up.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1530891X25009371

Empowering Diabetes Care Through Pharmacist-Led ... The pharmacist-led DSME program was effective in enhancing glycemic control, diabetes knowledge, self-management behaviors, and HRQoL in ...

2. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.70015

Long‐term effect of pharmacist‐led interventions on diabetes ... Pharmacist-led educational interventions significantly reduced diabetes distress, hemoglobin A1C (A1C), weight, and Patient Health Questionnaire-2 (PHQ-2) ...

3. nature.com nature.com/articles/s41598-025-04439-w

Effect of pharmacist led intervention on health related ... The pharmacist collaborative care in the form of intervention turned out effective in enhancing the patient reported quality of life as well as in improving ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12068403/

Impact of Pharmacist Interventions on Health Outcomes of ... Pharmacist intervention significantly reduces LDL-C, triglycerides, and total cholesterol levels in type 2 diabetes patients through ...

5. academic.oup.com academic.oup.com/jphsr/article/15/2/rmae005/7634595

Pharmacist-led intervention to improve treatment outcomes in ... Pharmacist-led intervention significantly improved medication refills, glycemic control, knowledge, and medication adherence. Pharmacists ...