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

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.

Study Overview

• Status: Recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Other: Prompt-sheet; Other: Usual education

Detailed Description

The objectives of this study are to systematically (a) identify middle-aged and older adults taking SU within a large integrated health system, and empower them to explore alternative, evidence-based treatments with their primary care providers to address and implement the ADA practice guideline as an actionable target to improve patient safety; and (b) engage our primary care providers in a systematic quality implementation and improvement program that includes education about contemporary T2D guideline recommendations, benefits, and drawbacks of different classes of agents, and formulary alternatives to SU. These objectives will be accomplished in the following 3 aims:

1. Empower patients to discuss treatments options with their primary care provider.

   Using an electronic data warehouse, the investigators will identify patients aged ≥45 years with type 2 diabetes who are currently prescribed SU and implement a strategy to encourage patients to discuss SU and alternatives with their primary care providers using a question-based prompt sheet. A control group will receive an overview sheet of diabetes medications.

2. Engage primary care providers in a quality implementation and improvement program.

   The program includes education about contemporary T2D guideline recommendations, benefits, and drawbacks of different classes of agents, and formulary alternatives to SU. An academic detailer will visit each primary care practice up to twice during the study period to provide targeted education about alternatives to SU to promote safety.

3. Measure key process outcomes and patient-centered outcomes at regular intervals.

Participants will be surveyed every 3 months during their first year of participation to identify if they had discussed alternatives. The investigators hypothesize that half of intervention group patients will have had such discussions compared with only 25% in the control group. Other outcomes will include assessment of hypoglycemia symptoms, discontinuation rates of SU, initiation of new medications, diabetes and financial distress (via surveys), and clinical outcomes (extracted from the electronic medical record) including glycosylated hemoglobin (Hb A1c), body weight, blood pressure, and lipids.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ian Neeland, MD; Phone Number: 216-844-5965; Email: Ian.Neeland@UHhospitals.org
• Study Contact Backup: Name: Amanda Davies, MBA; Phone Number: 216-844-7635; Email: Amanda.Davies@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Joseph Rutter; Phone Number: 216-286-5025; Email: Joseph.Rutter@UHhospitals.org
      • Contact: Ann Dever, RN; Phone Number: 2162865038; Email: ann.dever@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Prompt-sheet; 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.
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).	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who switched from a SU to an alternative medication	Proportion of patients who switched from a SU to an alternative medication	12 months
Proportion of patients who discontinued a SU	Proportion of patients who discontinued a SU	12 months
Proportion of patients who experienced a hypoglycemia event by self-report	Proportion of patients who experienced a hypoglycemia event by self-report	12 months
Hb A1c	glycosylated hemoglobin	12 months
BMI	body mass index	12 months
Lipid levels	Lipid levels	12 months
The Personal Financial Well-being Scale	. The financial well-being scale is a free tool to help measure the financial well-being of people you serve. The scale, which was developed and rigorously tested by The Consumer Financial Protection Bureau, contains 10 questions to capture how people feel about their financial security and freedom of choice, plus 2 questions to assist with scoring. Responses to the questions can be converted into an overall financial well-being "score" between 0 and 100.	12 months
Diabetes Distress Scale	17-item self-report survey to assess an individual's level of stress related to living with diabetes. Each question has an answer rating from 1 ("not a problem") to 5 ("a very serious problem").	12 months
Blood pressure (systolic and diastolic)	Blood pressure (systolic and diastolic)	12 months

Collaborators and Investigators

• Sponsor: Ian J. Neeland, MD
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Ian Neeland, MD, University Hospital Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sulfonylureas
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY20230836; Neeland AHA 23SCISA1144816 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No