Pharmacist-Led Management for Type 2 Diabetes

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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for managing type 2 diabetes?

Research shows that pharmacist-led self-management programs for diabetes can significantly improve important health measures like HbA1c (a marker of blood sugar control), blood pressure, and cholesterol levels. These programs also help patients develop better self-management skills and improve adherence to their medication, leading to better overall diabetes management. ^{1 2 3 4 5}

Is pharmacist-led management for type 2 diabetes safe?

Pharmacist-led management for type 2 diabetes involves using medications that have been generally found to be safe when used correctly. The safety of these medications, such as insulin and metformin, is well-documented, but newer drugs may have unresolved safety questions. Overall, these treatments are considered safe, but individual circumstances should be considered. ^{2 6 7 8 9}

How is pharmacist-led management for type 2 diabetes different from other treatments?

Pharmacist-led management for type 2 diabetes is unique because it involves pharmacists actively managing and optimizing medication therapy, providing personalized care, and potentially improving patient outcomes by preventing complications. This approach leverages the pharmacist's expertise in medication management, which is not typically a focus in standard diabetes care. ^{5 7 10 11 12}

What is the purpose of this trial?

Type 2 diabetes is a chronic disease that can lead to a number of complications if uncontrolled and there is a projected increase of 33% patients living with diabetes over the next 10 years. There can be improvements to modifiable risk factors such as diet and exercise, in addition to medications. Treatment often involves a multidisciplinary approach with a physician, endocrinologist, dietitian, pharmacist and other support health professionals as required. This study will evaluate the effects of the pharmacists (or pharmD interns) intervention, looking at changes to the patients HbA1C, which is a measure of the patients blood glucose control over the previous 3 months as well as the patients understanding and comfort with managing their own diabetes via participant survey.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of a short, interactive diabetes self-management program by pharmacists for type 2 diabetes. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

A pharmacotherapy follow-up program in patients with type-2 diabetes in community pharmacies in Spain. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of a pharmacist-led diabetes management on outcomes, utilization, and cost. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacist-Led Self-management Interventions to Improve Diabetes Outcomes. A Systematic Literature Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Provision of Medication Therapy Management by Pharmacists to Patients With Type-2 Diabetes Mellitus in a Federally Qualified Health Center. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The intervention strategies and service model for pharmacist-led diabetes management: a scoping review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Medication adherence program: adherence challenges and interventions in type 2 diabetes. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes]. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Risk vs benefit in diabetes pharmacotherapy: a rational approach to choosing pharmacotherapy in type 2 diabetes. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

"Prescribing for the whole person": A qualitative study exploring prescribing pharmacist views on type 2 diabetes management in New Zealand. [2023]