MedDataX Logo

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

NCT ID: NCT05933174

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type2diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Sulfonylureas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Prompt-sheet

Intervention Type 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

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).

Group Type ACTIVE_COMPARATOR

Usual education

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ian J. Neeland, MD

OTHER

Sponsor Role lead

American Heart Association

OTHER

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ian J. Neeland, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ian Neeland, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cleveland Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ian Neeland, MD

Role: CONTACT

Phone: 216-844-5965

Email: [email protected]

Amanda Davies, MBA

Role: CONTACT

Phone: 216-844-7635

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ann Dever, RN

Role: primary

Joseph Rutter

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Neeland AHA 23SCISA1144816

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY20230836

Identifier Type: -

Identifier Source: org_study_id