Promoting Alternatives to Sulfonylureas to Improve Patient Safety in Type 2 Diabetes

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Ian J. Neeland, MD
Study ID
NCT05933174
Status
Recruiting
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Conditions

  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prompt-sheet — OTHER
    Simple prompt sheet with which participants 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.
  • Usual education — OTHER
    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).

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Prompt-sheet
    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.
  • Active Comparator: Usual education
    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).

Primary Outcome Measure

Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Ann Dever, RN
[email protected]
2162865038
Joseph Rutter
[email protected]
216-286-5025

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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