Telehealth Pharmacist Intervention for Type 2 Diabetes

Overseen By McKenzie Isreal, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Gestational diabetes, Type 1 diabetes, Serious mental illnesses, Malignant cancer, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a telehealth pharmacist can better manage Type 2 diabetes in rural areas. Participants will either continue their usual care or receive telehealth support from a pharmacist. The pharmacist will address medication issues and provide education on managing diabetes. Suitable candidates have uncontrolled Type 2 diabetes (with high blood sugar levels) and are not part of other similar programs.

As an unphased trial, this study offers a unique opportunity to explore innovative care methods that could enhance diabetes management in rural communities.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this telehealth-based clinical pharmacy intervention is safe for patients with Type 2 diabetes?

Research has shown that telehealth for pharmacy services is safe and effective for people with Type 2 diabetes. Studies have found that pharmacists can successfully address medication issues, such as incorrect doses or drug interactions, through telehealth. This approach not only improves health but also enhances patient safety.

A review of digital health services led by pharmacists found no serious side effects. Patients managed their diabetes better without major safety problems. Additionally, telehealth services have been linked to improved health outcomes, such as fewer hospital visits, indicating their safety.

Overall, telehealth in pharmacy care appears to be a safe and effective way to manage Type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this telehealth-based clinical pharmacy intervention because it offers a fresh approach to managing Type 2 Diabetes by leveraging remote healthcare. Unlike traditional treatments that typically involve in-person visits to manage medication regimens, this method uses telehealth to allow pharmacists to directly address medication-related issues, optimize prescriptions, and support patient education remotely. This approach not only simplifies medication plans and potentially reduces costs with generic options but also empowers patients with self-management tools, making diabetes care more accessible and personalized.

What evidence suggests that this telehealth-based clinical pharmacy intervention is effective for Type 2 diabetes?

Research shows that telehealth services for pharmacy support can help lower blood sugar levels in people with Type 2 diabetes. In this trial, participants will receive either a telehealth-based clinical pharmacy intervention or usual care. One study found that patients receiving pharmacist-led support through telehealth had similar improvements in their A1C levels, an important measure of blood sugar, as those receiving traditional care. Another study found that telehealth services can resolve medication issues, such as incorrect dosages and drug interactions, leading to better overall treatment plans. Additionally, pharmacist support through mobile health programs has improved blood sugar levels, especially in diverse populations. These findings suggest that this approach could effectively manage diabetes, particularly in rural areas. ^{1 6 7 8 9}

Who Is on the Research Team?

Rohan Mahabaleshwarkar, PhD

Principal Investigator

Atrium Health Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 living in rural areas with uncontrolled Type 2 diabetes, as shown by their health records. Participants must have a recent HbA1c level of at least 8%. People with cancer, other chronic disease programs, specialist T2D care, or serious mental illnesses are excluded.

Inclusion Criteria

HbA1c reading ≥ 8% recorded during 6 months prior to or up to 9 days after the encounter at the participating practices

My type 2 diabetes has been uncontrolled in the past year.

Exclusion Criteria

I am currently being treated for type 2 diabetes by an endocrinologist.

I have either gestational or type 1 diabetes.

Those enrolled in any other chronic disease management programs delivered by non-physician healthcare professionals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a telehealth-based clinical pharmacy intervention for diabetes management, including biweekly video/phone calls with a pharmacist for 3 months

12 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in blood pressure, HbA1c, and medication adherence from baseline to follow-up

17 months

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth-based Clinical Pharmacy Intervention

Trial Overview The study tests if having a pharmacist provide telehealth support for diabetes management in rural primary care helps control Type 2 diabetes better and if it's worth expanding this service within the healthcare system.

How Is the Trial Designed?

Group I: telehealth-based clinical pharmacy intervention Experimental Treatment 1 Intervention

will involve a pharmacist identifying and addressing medication-related problems (e.g., inappropriate dosage or indications, drug interactions, and therapeutic duplication); optimizing medication regimens (discontinuing if appropriate, providing subsidized and generic options, and reducing medication complexity); and providing T2D education and self-management support

Group II: usual care Active Control 1 Intervention

will involve routine physician office visits every 3 (for those with HbA1c outside goal) - or every 6 months (for those with HbA1c within goal). Medication regimens are usually managed by physicians, nurse practitioners, and physician assistants, and Patients have access to centralized chronic disease management programs.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131742/

Evaluation of pharmacist impact on diabetes outcomes for ... Reductions in A1C were comparable for patients with diabetes utilizing pharmacist-led telehealth, virtual, and/or in-office visits · No significant differences ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1871402125000694

a systematic review and meta-analysis of interventions Our study demonstrates effectiveness for telemedicine-delivered interventions in preventing T2D in people at risk, specifically in people with overweight/ ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12427938/

Pharmacists' Interventions in Virtual Diabetes Clinics: Cost- ... The outcomes of our study's primary aim were characteristics of patients referred to the clinic, types of drug-related problems, and the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05761886

Rural Area Pharmacist Intervention for Diabetes Novel approaches such as telehealth and supportive clinical management of T2D by non-physician providers have been recommended to fill gaps in care. With ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809969

Mobile Health Intervention in Patients With Type 2 Diabetes A clinical pharmacist and health coach–delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05761886

Rural Area Pharmacist Intervention for Diabetes Novel approaches such as telehealth and supportive clinical management of T2D by non-physician providers have been recommended to fill gaps in care. With ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11735830/

Pharmacist-Led Digital Health Interventions for Patients ... The aim of this study was to conduct a systematic review of pharmacist-led digital health interventions for patients with diabetes.

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2794747

Effect of a Comprehensive Telehealth Intervention vs ... A comprehensive telehealth intervention improved outcomes in persistently poorly controlled type 2 diabetes compared with a simpler telehealth intervention.

9. jmir.org jmir.org/2025/1/e57129

Telehealth Interventions in Pharmacy Practice: Systematic ... This table summarizes the effects of telehealth interventions on health outcomes, including hospital readmissions, patient safety, medication ...