What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists. Metformin is generally well-tolerated but can cause gastrointestinal issues such as diarrhea and nausea. Sulfonylureas may lead to hypoglycemia and weight gain. DPP-4 inhibitors are associated with a low risk of hypoglycemia but can cause nasopharyngitis and, rarely, pancreatitis. SGLT2 inhibitors can lead to urinary tract infections, genital infections, and an increased risk of dehydration. GLP-1 receptor agonists often cause gastrointestinal side effects like nausea and vomiting and have been linked to a potential risk of pancreatitis.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes that align with collaborative care and medication adjustment approaches. Notable among these are GLP-1 receptor agonists such as liraglutide and exenatide, which have shown efficacy in glycemic control and cardiovascular benefits. Additionally, SGLT2 inhibitors like dapagliflozin have been approved for their ability to lower blood glucose levels and provide cardiovascular and renal benefits. These medications can be effectively managed and adjusted within a collaborative care framework to meet ADA guidelines, similar to the goals of the Pharmacist-led Diabetes Management Program.

What other types of research exist?

Promising alternatives to Pharmacist-led Diabetes Management Programs for Type 2 Diabetes patients include: 1) Use of GLP-1 receptor agonists and SGLT2 inhibitors, which have shown significant cardiovascular benefits and low risk of hypoglycemia. 2) Digital health interventions, such as continuous glucose monitoring (CGM) systems and mobile health applications, which provide real-time data and personalized feedback. 3) Integrated care models involving multidisciplinary teams, including endocrinologists, dietitians, and diabetes educators, to provide comprehensive and individualized care. 4) Lifestyle modification programs focusing on diet, exercise, and weight management, which have demonstrated efficacy in improving glycemic control and overall health outcomes.

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Pharmacist-Led Care for Diabetes

N/A

Waitlist Available

Led By Kathryn E. Callahan, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently taking a sulfonylurea or insulin for Type 2 Diabetes Mellitus (T2DM)

At least 2 consecutive International Classification of Diseases 10th Revision (ICD-10) codes for type two diabetes mellitus in the prior 2 years

Must not have

Diagnosed Alzheimer's disease or related dementia (unable to participate)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through month 18

Awards & highlights

Summary

This trial is testing whether a pharmacist-led diabetes management program can help optimize care and lower blood sugar for older adults with diabetes, by meeting with them and potentially adjusting their medications.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include changes related to medication adjustments such as low blood sugar levels (hypoglycemia), especially since insulin or sulfonylureas are involved which commonly cause this when dosages are altered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with type 2 diabetes in the last 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through month 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through month 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in HbA1c

Estimated Change in Out-of-Pocket Costs

Feasibility Measures: Effort Required to Enroll-Average Call Duration

+8 more

Secondary outcome measures

Implementation Metric- Value

Implementation Metric-- Acceptability

Implementation Metric-- Appropriateness

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Active InterventionExperimental Treatment1 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 DeclinersActive Control1 Intervention

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

Group III: ControlActive Control1 Intervention

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include metformin, which decreases hepatic glucose production and increases insulin sensitivity; sulfonylureas, which stimulate insulin secretion from pancreatic beta cells; DPP-4 inhibitors, which enhance incretin levels to increase insulin release and decrease glucagon levels; GLP-1 receptor agonists, which mimic incretin hormones to increase insulin secretion, decrease glucagon, and slow gastric emptying; and insulin therapy, which directly supplements insulin levels. These treatments are crucial for Type 2 Diabetes patients as they address different aspects of glucose regulation, helping to achieve better glycemic control and reduce the risk of complications.

Assessing the quality of the evidence underlying recommendations in type 2 diabetes' commonly used clinical practice guidelines.Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.