Education Strategies for Safer Medication Use in Type 2 Diabetes

Overseen By Amanda Davies, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must be taking: Sulfonylureas

Disqualifiers: Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 5

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how to assist people with type 2 diabetes in discussing the transition from older, potentially riskier medications called sulfonylureas to newer, safer options with their doctors. It tests whether a prompt sheet with questions can foster better conversations with healthcare providers. Participants will be divided into two groups: one will receive a question prompt sheet, and the other will receive general information about diabetes medications. This trial targets individuals aged 45 or older who have had type 2 diabetes since before the end of 2021 and are currently taking sulfonylureas. As an unphased trial, this study provides a unique opportunity to improve communication with healthcare providers and potentially enhance treatment plans.

Will I have to stop taking my current medications?

The trial focuses on encouraging discussions about switching from sulfonylurea medications to newer alternatives. It does not specify if you must stop your current medications, but it aims to promote safer options.

What prior data suggests that these education strategies are safe for promoting medication discussions in type 2 diabetes?

Research has shown that sulfonylurea medications, commonly used to treat type 2 diabetes, can be risky for older adults. These drugs have been linked to low blood sugar, falls, and increased heart problems. Due to these risks, newer and safer options like GLP-1 agonists and SGLT2 inhibitors are recommended.

Ongoing research aims to promote safer medication choices by improving communication between patients and doctors. The main tool being tested is a simple sheet with questions, designed to help patients discuss their medications with healthcare providers.

There are no safety concerns with using this question sheet. As a tool for better communication, not a medication or treatment, it has no reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to educate people with Type 2 Diabetes on using their medications safely. The trial compares standard educational brochures with a novel "prompt-sheet" designed to encourage patients to engage in meaningful conversations with their healthcare providers. This prompt-sheet stands out because it empowers patients to ask targeted questions, drawing from trusted sources like the Agency for Healthcare Research and Quality's Question Builder App and the Canadian Deprescribing Network. This approach could enhance patient understanding and involvement in their treatment, which is crucial for managing diabetes effectively.

What evidence suggests that this trial's education strategies could be effective for safer medication use in type 2 diabetes?

In this trial, researchers will divide participants into two groups to evaluate different educational strategies for safer medication use in Type 2 Diabetes. One group will receive a prompt sheet, which previous studies have shown effectively initiates important conversations between patients and doctors. For instance, prompt sheets have facilitated discussions on health issues like sexual problems during regular doctor visits, helping patients feel more comfortable addressing concerns that might otherwise be ignored. In diabetes care, prompts have been part of programs that change patient behavior, making them a promising tool for improving doctor-patient talks about medication choices. This method encourages discussions about safer alternatives to sulfonylureas, a type of diabetes drug linked to risks like low blood sugar and heart problems. Overall, prompt sheets can empower patients to make informed decisions about their treatment. Meanwhile, the control group will receive usual education, consisting of an information brochure with content from the NIDDK about diabetes medications. ^{4 6 7 8 9}

Who Is on the Research Team?

Ian Neeland, MD

Principal Investigator

University Hospital Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 45 and older with type 2 diabetes who have been seeing their primary care provider since at least 2021, are currently prescribed sulfonylurea medications, and can discuss medication changes with their doctor. It excludes those whose doctors advise against participation or who cannot give informed consent.

Inclusion Criteria

I am currently taking medication for diabetes.

Established care (≥2 visits) with UH primary care provider (PCP) since 2021

I am 45 years old or older.

Exclusion Criteria

I have Type 1 diabetes.

I am unable to understand and give consent for treatment.

PCP provides a reason why patient participation is inappropriate (e.g., known cost barriers without any alternatives, prior discussion with patient about alternatives, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are divided into an intervention group receiving a question-prompt sheet and a control group receiving a general brochure on diabetes medications. Primary care providers receive education about newer diabetes medications.

12 months

Up to 2 visits (in-person) for provider education

Follow-up

Participants are monitored for discussions about sulfonylureas and alternatives, discontinuation rates, and clinical outcomes such as Hb A1c, blood pressure, and lipid levels.

12 months

Surveys every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Prompt-sheet
• Usual education

Trial Overview

The study tests whether using a prompt-sheet to encourage patient-doctor discussions about the risks of sulfonylureas (a diabetes drug) leads to switching to safer alternatives. One group gets prompting questions; another gets general info. Doctors also learn about newer drugs.

How Is the Trial Designed?

Group I: Prompt-sheet Experimental Treatment 1 Intervention

Question-prompt group patients will receive a simple prompt sheet with the questions with which they will encouraged to use to guide a conversation with their provider at their next visit for routine diabetes care. These questions are based on recommendations from the Agency for Healthcare Research and Quality's Question Builder App and also on recommendations from the Canadian Deprescribing Network which specifically addresses SU use.

Group II: Usual education Active Control 1 Intervention

Control group patients will be sent an information brochure with content from the NIDDK about diabetes medications (https://www.niddk.nih.gov/health-information/diabetes/overview/insulin-medicines-treatments).

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Ian J. Neeland, MD

Lead Sponsor

Trials

2

Recruited

280+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Dapagliflozin (DAPA) is an effective SGLT2 inhibitor for treating type 2 diabetes, showing favorable pharmacokinetics and pharmacodynamics that help lower blood sugar levels while having beneficial effects on other metabolic risk factors.

While DAPA is generally safe, it carries an increased risk of genital and urinary infections, and concerns about bladder cancer and cardiovascular safety remain, prompting the FDA to seek further data on these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. Maranghi, M., Carnovale, A., Durante, C., et al.[2021]

Dapagliflozin is an effective SGLT2 inhibitor for managing type 2 diabetes, showing consistent reductions in blood glucose levels and body weight over long-term follow-up periods of 1-4 years across various clinical trials.

It has a low risk of causing hypoglycemia and is generally well tolerated, although it can lead to genital infections, particularly in women, and is not recommended for patients with moderate to severe renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: a review of its use in patients with type 2 diabetes. Plosker, GL.[2022]

Educational interventions, such as pharmacist-led and nurse-provided diabetes education, significantly improve adherence to oral hypoglycaemic medications in adults with Type 2 diabetes, as shown in five out of seven reviewed randomized controlled trials.

Regular education sessions enhance patients' knowledge about their medications and the importance of adherence, which is crucial for achieving better glycaemic control and preventing complications associated with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes: a systematic review. Lun Gan, JK., Brammer, JD., Creedy, DK.[2020]

Dapagliflozin (Forxiga) is no longer authorized for the treatment of type 1 diabetes mellitus, indicating a significant change in its regulatory status.

This decision reflects safety concerns or efficacy issues that may have arisen from clinical evaluations or post-marketing surveillance, emphasizing the importance of ongoing drug safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin no longer licensed for type 1 diabetes. [2022]

Dapagliflozin (Farxiga) is approved for reducing the risk of declining kidney function and kidney failure in adults with chronic kidney disease, regardless of whether they have type 2 diabetes.

It also helps lower the risk of cardiovascular death and hospitalization for heart failure, highlighting its efficacy in managing both kidney and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. Aschenbrenner, DS.[2023]

Diabetes self-management education programs for children and young adults significantly improve glycaemic control, as evidenced by a review of 40 articles published between 2000 and 2007.

The effectiveness of these educational programs increases with the duration of training, indicating that more extensive education leads to better management of blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Educational program to type 1 diabetes mellitus patients: basic topics]. Leite, SA., Zanim, LM., Granzotto, PC., et al.[2022]

Dapagliflozin is an effective treatment for type 2 diabetes, proven through multiple controlled clinical trials that assess its efficacy, safety, and tolerability.

It is approved by the FDA for use as a standalone therapy or in combination with other glucose-lowering medications, including insulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. Davis, PN., Ndefo, UA., Oliver, A.[2021]

Dapagliflozin is an effective oral medication for managing type 2 diabetes by inhibiting glucose reabsorption in the kidneys, which helps lower blood sugar levels when diet and exercise alone are insufficient.

In addition to improving glycemic control, dapagliflozin may also aid in weight loss, making it a beneficial option for patients who struggle with weight gain from other diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin (Forxiga) for type 2 diabetes? [2021]

Successful therapeutic patient education for diabetes management requires patient acceptance of their illness, an interactive educational process, and the establishment of short, medium, and long-term therapeutic goals with the patient.

Before starting any medication, a dietary program and daily physical activity are essential, as they form the foundation of diabetes treatment, with pharmacological options like insulin analogues and insulin sensitizers available to help manage blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Follow-up, therapeutic education, and pharmacologic treatments of patients with type 2 diabetes. Various critical views]. Assal, JP., Dayer-Metroz, MD.[2007]

In a study of 505 adults with type 2 diabetes, higher knowledge about diabetes was linked to better medication adherence and improved glycemic control, as measured by HbA1C levels.

Patients who had better knowledge and adherence scores were more likely to achieve lower HbA1C levels, suggesting that enhancing patient education could be a key strategy for improving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes knowledge, medication adherence and glycemic control among patients with type 2 diabetes. Al-Qazaz, HKh., Sulaiman, SA., Hassali, MA., et al.[2022]

Diabetes self-management education (DSME) is essential for improving health outcomes in people with diabetes, yet it remains underutilized despite evidence showing it can reduce hospitalization costs and improve glucose control, weight management, and medication adherence.

The future of DSME faces significant challenges in the current healthcare system, particularly in integrating diabetes education with clinical care, highlighting the need for new strategies and guidelines to meet the growing demand for diabetes educators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes education: looking through the kaleidoscope. Tomky, D.[2013]

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