Pharmacist-Led Management for Type 2 Diabetes

Not currently recruiting at 1 trial location

Overseen By Jamey LG Willsey, BScPharm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Type 1 diabetes, Severe renal impairment, others

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

Compensation: Varies

Number of Visits: 2

Duration: 10 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pharmacist-led management can help people with type 2 diabetes better control their blood sugar levels. It compares two groups: one receiving regular doctor care and the other receiving additional support from a pharmacist. The trial aims to determine if pharmacists can improve blood sugar control and boost patients' confidence in managing their diabetes. This trial may suit those with type 2 diabetes whose blood sugar levels (HbA1C) remain consistently high and who have not previously worked with a clinical pharmacist. As an unphased trial, it offers a unique opportunity to explore innovative diabetes management strategies with pharmacist support.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be willing to consider medication adjustments as deemed appropriate by the study team.

What prior data suggests that this pharmacist-led management is safe for diabetes patients?

Research has shown that pharmacist involvement in diabetes management is generally safe and well-tolerated. Studies have found that this approach helps people adhere to their medication regimen and improve blood sugar control, which is crucial for managing diabetes.

One study found a significant drop in A1c levels, which measure long-term blood sugar, when pharmacists were involved. Another study demonstrated that these interventions helped reduce diabetes-related stress over time.

Reports of serious side effects directly linked to pharmacist-led interventions are absent. Since this method uses existing, approved diabetes treatments, it suggests a good safety profile.

In summary, evidence supports that pharmacist-led care for diabetes is safe and offers additional benefits in managing the condition effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing Type 2 Diabetes by involving pharmacists more directly in patient care. Unlike standard treatments that primarily rely on physicians for adjustments and monitoring, this approach includes pharmacists to provide tailored medication reviews and more frequent follow-ups. This could lead to more personalized and responsive diabetes management, potentially improving patient outcomes by ensuring medications are optimized and any necessary changes are made quickly.

What evidence suggests that this trial's treatments could be effective for managing Type 2 diabetes?

This trial will compare standard care with and without pharmacist intervention for managing Type 2 diabetes. Research has shown that pharmacist involvement can be very effective for people with Type 2 diabetes. Participants in the Pharmacist Intervention Arm will receive additional support from a pharmacist, which has been shown to lower HbA1c levels, a measure of blood sugar control, by an average of 0.75%. This results in better blood sugar management over time. Studies also indicate that these programs help people take their medications as prescribed. Patients often gain more knowledge about their condition and see improvements in other health areas, such as blood pressure and cholesterol. Overall, pharmacist involvement can make managing diabetes easier and more effective. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with uncontrolled type 2 diabetes (HbA1C of 10% or higher) who are willing to adjust medications, monitor blood glucose at home, and have not had pharmacist-directed interventions before. They must be patients of the Portage Clinic and consent to participate fully.

Inclusion Criteria

Patients whose primary care physician is within the Portage Clinic

You have not received guidance from a clinical pharmacist before.

Willing to review and sign the Research Participant Information and Informed Consent Form

Exclusion Criteria

I am under 18 years old.

I have severe kidney problems or am on dialysis.

I refuse to change my current medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomized into control or intervention groups, with the intervention group receiving pharmacist-led care including medication review and diabetes education

10 months

Frequent follow-up visits (in-person and virtual)

Follow-up

Participants are monitored for changes in HbA1C, BMI, blood pressure, and cholesterol levels, and complete a participant survey

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral and drugs already approved and available for diabetes management

Trial Overview The study evaluates how effective pharmacists' interventions are in managing type 2 diabetes by looking at changes in HbA1C levels and patient self-management skills through surveys. It involves behavioral strategies and approved diabetes drugs.

How Is the Trial Designed?

Group I: Control Arm Active Control 1 Intervention

The participants in this arm will receive standard of care from their physician as they would have been doing previously. This still may involve blood work, referrals to other health providers (except pharmacist) and medication adjustments driven by the pharmacist.

Group II: Pharmacist Intervention Arm Active Control 1 Intervention

The participants in this arm will receive standard of care from their physician in addition to pharmacist intervention. The pharmacist or pharmD intern leads the diabetes care for the patient typically, conducting a medication review, recommending medication changes, frequent follow up and requesting blood work and providing referrals to other health care providers as needed,which is standard care

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

The U.S. FDA has approved six classes of oral medications for type 2 diabetes, with metformin and lifestyle changes recommended as the first-line treatments according to a consensus by the American Diabetes Association and the European Association for the Study of Diabetes.

New therapies in development, including incretin therapies and agents targeting metabolic syndrome, show promise for improving treatment options for type 2 diabetes, especially for patients struggling with weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes: new and future developments in treatment. Liao, EP.[2022]

A review of safety evidence for six major diabetes drug classes indicates that all options have reasonable safety margins when used appropriately, allowing for personalized treatment regimens for type 2 diabetes.

While established medications like metformin, sulfonylureas, and insulin are effective for most patients, there are still unmet clinical needs, highlighting the importance of early intervention and potential combination therapies tailored to individual patient circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond metformin: safety considerations in the decision-making process for selecting a second medication for type 2 diabetes management: reflections from a diabetes care editors' expert forum. Cefalu, WT., Buse, JB., Del Prato, S., et al.[2022]

The review highlights that while there are many innovative drugs being developed for type 2 diabetes, several have faced serious safety issues, leading to their withdrawal or halting of development.

It discusses the current state of treatments, including glitazones, incretin mimetics, SGLT-2 inhibitors, and new experimental drugs, emphasizing the need for better methods to predict and differentiate drug-related adverse events from natural disease occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes]. Schindler, C., Barthel, A., Fischer, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6791080/

A Review of Pharmacist-led Interventions on Diabetes ... Pharmacist-led interventions are able to reduce HbA1c levels with a mean of 0.75%. Most studies do not expose the material and methods used in pharmacist-led ...

2. 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 should ...

3. japha.org japha.org/article/S1544-3191(25)00078-0/fulltext

The impact of a pharmacist-led Comprehensive Diabetes ... The study enrolled 518 patients, revealing a statistically significant mean reduction in A1c levels, alongside observed cost savings in health ...

4. 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) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S073839912300472X

A meta-analysis of the impact of pharmacist interventions ... Pharmacist interventions significantly improved HbA1c, BP, and LDL-C control levels, BMI, and medication adherence in type-2 diabetes patients.

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

Empowering Diabetes Care Through Pharmacist-Led ... This study aimed to evaluate the effectiveness of a pharmacist-led diabetes self-management education (DSME) intervention on clinical outcomes, ...

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

Pharmacist-Led Digital Health Interventions for Patients ... Five studies (26.31%) showed that such interventions increased medication adherence, while two studies (10.53%) found no difference when ...