Education Strategies for Safer Medication Use in Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
Sulfonylurea medications are unsafe for older patients with diabetes. They are associated not only with hypoglycemia, but also with falls and increased cardiovascular risk. Yet they continue to be prescribed frequently. Indeed, older adults with type 2 diabetes, who are especially prone to adverse effects, are more likely to be prescribed sulfonylureas than younger patients. This is unfortunate since over the past several years, newer, safer, and more effective classes of medications (GLP-1 agonists and SGLT2-inhibitors) have emerged. The investigators acknowledge that sulfonylureas are inexpensive and that their low cost is a driver of continued use. However, the investigators believe patients and providers should have discussions about the risks of sulfonylureas and safer and more effective alternatives, to make diabetes care safer overall in ambulatory settings. Our research is designed to promote such discussions. The investigators will first identify patients taking sulfonylureas regularly. Next, using recommendations from AHRQ and the Canadian Deprescribing Network, the investigators will empower patients to discuss their medications with their providers through a simple question prompt sheet. Patients will be divided into an intervention group which receives explicit prompting questions, and a control group that receives a general brochure on diabetes medications. Health care providers will receive education about newer diabetes medications through case-based discussions and academic detailing. Finally the investigators will measure key outcomes including the proportion of patients who have discussions about sulfonylureas and alternatives, rates of discontinuation, and measures of control of diabetes and associated cardiovascular risks. The investigators will also evaluate the experiences of patients and providers qualitatively through brief, semi-structured interviews. Should our multi-faceted, patient-oriented intervention prove effective in promoting discussions of sulfonylureas and alternatives, and also discontinuation of sulfonylureas and switching to newer alternatives, the investigators will incorporate our prompting questions into routine care for patients taking sulfonylureas. Our intervention can be easily disseminated to other settings and therefore has considerable potential to improve safety among patients with type 2 diabetes nationwide.
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.
Is dapagliflozin safe for humans?
Dapagliflozin, also known as Farxiga or Forxiga, is generally well tolerated in humans for the treatment of type 2 diabetes, with a low risk of low blood sugar (hypoglycemia) and common side effects like genital infections. It is not recommended for people with moderate or severe kidney problems.12345
How does this educational treatment for Type 2 diabetes differ from other treatments?
This treatment focuses on education strategies to improve medication adherence and self-management in Type 2 diabetes, which is different from traditional drug treatments. It aims to empower patients with knowledge to better manage their condition, potentially leading to improved glycemic control and reduced hospitalizations.678910
What data supports the effectiveness of the drug Farxiga (dapagliflozin) for safer medication use in type 2 diabetes?
Research shows that Farxiga (dapagliflozin) helps lower blood sugar levels and body weight in people with type 2 diabetes, and it is generally well tolerated. It also reduces the risk of kidney problems and heart-related issues in people with chronic kidney disease, even if they don't have diabetes.124511
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
What Are the Treatments Tested in This Trial?
Interventions
- Prompt-sheet
- Usual education
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor
Ian J. Neeland, MD
Lead Sponsor
American Heart Association
Collaborator