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

NCT05933174 | Recruiting

• 2 other identifiers: STUDY20230836Neeland AHA 23SCISA1144816
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2diabetes

Keywords

Sulfonylureas

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management

  Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management

  12 months

Secondary Outcomes (9)

• Proportion of patients who switched from a SU to an alternative medication

  12 months

• Proportion of patients who discontinued a SU

  12 months

• Proportion of patients who experienced a hypoglycemia event by self-report

  12 months

• Hb A1c

  12 months

• BMI

  12 months

Study Arms (2)

Prompt-sheet

EXPERIMENTAL

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.

Other: Prompt-sheet

Usual education

ACTIVE COMPARATOR

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).

Other: Usual education

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.

Prompt-sheet

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).

Usual education

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Self-identified gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years
• Type 2 diabetes (diagnosed on or before 12/31/2021)
• Current/active prescription for one or more SU medications
• Established care (≥2 visits) with UH primary care provider (PCP) since 2021

You may not qualify if:

• Type 1 diabetes
• PCP provides a reason why patient participation is inappropriate (e.g., known cost barriers without any alternatives, prior discussion with patient about alternatives, etc.)
• Patient unable or unwilling to have conversation with their PCP regarding SU
• Unable to provide informed consent

Sponsors & Collaborators

• Ian J. Neeland, MD: lead
• American Heart Association: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Study Officials

• Ian Neeland, MD

  University Hospital Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Neeland, MD

CONTACT

216-844-5965; ian.neeland@uhhospitals.org

Amanda Davies, MBA

CONTACT

216-844-7635; Amanda.Davies@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)