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Education Strategies for Safer Medication Use in Type 2 Diabetes

N/A

Recruiting

Led By Ian Neeland, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current/active prescription for one or more SU medications

Age ≥ 45 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial assesses how to make diabetes care safer by empowering patients to discuss their medications with providers & educating providers about newer, safer diabetes meds.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests whether using a prompt-sheet to encourage patient-doctor discussions about the risks of sulfonylureas (a diabetes drug) leads to switching to safer alternatives. One group gets prompting questions; another gets general info. Doctors also learn about newer drugs.See study design

What are the potential side effects?

While this trial focuses on education rather than direct medication effects, it addresses concerns that sulfonylureas may cause low blood sugar levels, falls, and increased heart risks in older patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently taking medication for diabetes.

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I am 45 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

BMI

Blood pressure (systolic and diastolic)

Diabetes Distress Scale

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prompt-sheetExperimental Treatment1 Intervention

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 II: Usual educationActive Control1 Intervention

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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

318 Previous Clinical Trials

339,865 Total Patients Enrolled

Ian J. Neeland, MDLead Sponsor

1 Previous Clinical Trials

56 Total Patients Enrolled

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,406 Total Patients Enrolled

Media Library

Prompt-sheet Clinical Trial Eligibility Overview. Trial Name: NCT05933174 — N/A

Type 2 Diabetes Research Study Groups: Usual education, Prompt-sheet

Type 2 Diabetes Clinical Trial 2023: Prompt-sheet Highlights & Side Effects. Trial Name: NCT05933174 — N/A

Prompt-sheet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05933174 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still ongoing for this clinical research?

"Clinicaltrials.gov data suggests that, since June 27th of this year, no participants have been enrolled in the study which was first posted on October 1st 2023. However, there are over a thousand other medical trials available at the moment and actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ian J. Neeland, MD 2023. "Promoting Alternatives to Sulfonylureas to Improve Patient Safety in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05933174.