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QBSafe for Type 2 Diabetes

N/A
Recruiting
Led By Kasia Lipska, MD MHS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinicians: any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management and prescribe medications for them
Participants diagnosed with DM2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

Study Summary

This trial is testing a new way to manage diabetes care that focuses on the patient's overall health and wellbeing, rather than just glycemic control.

Who is the study for?
This trial is for English or Spanish-speaking adults with Type 2 Diabetes who have an HbA1c level over 8%. It's open to patients able to give informed consent and healthcare providers involved in diabetes care. People with a life expectancy that makes higher HbA1c levels acceptable aren't eligible.Check my eligibility
What is being tested?
The QBSafe intervention, which includes conversation cards for patients to discuss their diabetes-related concerns and materials aiding clinicians' responses, is being tested for its impact on patient-reported outcomes.See study design
What are the potential side effects?
Since QBSafe is a communication-focused intervention rather than a medication, it does not have traditional side effects. However, participants may experience emotional or psychological impacts from discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthcare professional involved in managing type 2 diabetes.
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I have been diagnosed with type 2 diabetes.
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I am fluent in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HbA1c at Month 6
Illness intrusiveness measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6
Secondary outcome measures
Diabetes distress will be measured using the Diabetes Distress Scale (DDS-17) at Month 6
Hypoglycemia measured at month 6
Quality of communication assessed using 3 questions from the CAHPS Clinician and Group survey
+2 more
Other outcome measures
Clinician satisfaction survey
Patient satisfaction survey

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: QBSafe interventionExperimental Treatment1 Intervention
Group II: usual careActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,843 Previous Clinical Trials
2,735,073 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,348 Previous Clinical Trials
4,314,568 Total Patients Enrolled
Kasia Lipska, MD MHSPrincipal InvestigatorYale University

Media Library

QBSafe Clinical Trial Eligibility Overview. Trial Name: NCT05553912 — N/A
Type 2 Diabetes Research Study Groups: QBSafe intervention, usual care
Type 2 Diabetes Clinical Trial 2023: QBSafe Highlights & Side Effects. Trial Name: NCT05553912 — N/A
QBSafe 2023 Treatment Timeline for Medical Study. Trial Name: NCT05553912 — N/A

Frequently Asked Questions

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

What aims have been established for this experimentation?

"This month-long medical trial will assess the efficacy of HbA1c at Month 6. Secondary outcomes include Quality of Life, which is evaluated using a Visual Analogue Scale (VAS) survey ranging from 0 to 100; communication quality measured by 3 questions from the CAHPS Clinician and Group Survey; and distress levels monitored through the Diabetes Distress Scale (DDS-17)."

Answered by AI

Are there any vacancies for potential participants in this investigation?

"As seen on clinicaltrials.gov, this specific medical trial is no longer recruiting patients; it was first posted on January 1st 2023 and the last update occurred on November 17th 2022. Fortunately for those in search of a study to partake in, there are 1488 other trials actively looking for volunteers at present moment."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Fair Haven Community Health Center

Why did patients apply to this trial?

~59 spots leftby Jan 2025