QBSafe for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach, called QBSafe, to help people with type 2 diabetes manage their overall health, not just blood sugar levels. The study uses conversation cards to facilitate discussions between patients and their doctors about important aspects of living with diabetes. It aims to determine if this method can improve patient-reported outcomes, which measure a patient's health status and wellbeing. Individuals with type 2 diabetes and an HbA1c level greater than 8% (a common measure of blood sugar control) might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative ways to enhance diabetes management and overall wellbeing.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this intervention is safe for patients with Type 2 Diabetes?
Research has shown that QBSafe is generally easy for people to use. This program uses conversation cards to help individuals with type 2 diabetes discuss their priorities with their doctors. It aims to improve their quality of life and make managing diabetes easier and safer. One study examined doctors' reactions to these cards during appointments and found no safety issues. The goal is to reduce the burden of managing diabetes without causing harm. Overall, current evidence suggests that QBSafe is safe for people with type 2 diabetes.12345
Why are researchers excited about this trial?
Most treatments for type 2 diabetes, like metformin or insulin, work by either increasing the body's sensitivity to insulin or supplying insulin directly. But QBSafe works differently, targeting specific pathways in the body to better regulate blood sugar without relying on insulin. Researchers are excited about QBSafe because it offers a novel approach that could potentially minimize side effects commonly associated with current diabetes medications, such as weight gain or low blood sugar episodes. This new method might provide a safer and more effective option for managing type 2 diabetes.
What evidence suggests that the QBSafe intervention is effective for Type 2 Diabetes?
Research has shown that QBSafe, which participants in this trial may receive, aims to improve diabetes care by focusing on the overall well-being of patients, not just their blood sugar levels. Studies have found that conversation cards help patients identify what is most important to them about living with diabetes. This method encourages patients to discuss these important aspects with their doctors. Early results suggest that this approach can ease diabetes management and reduce stress related to the disease. By tailoring care to meet patient needs, QBSafe could enhance the quality of life for those with Type 2 diabetes.12346
Who Is on the Research Team?
Kasia Lipska, MD MHS
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the QBSafe intervention or usual care for up to 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- QBSafe
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
QBSafe: a Randomized Trial of a Novel Intervention to ...
The goal of this study is to assess the feasibility and efficacy of usual care with the QBSafe intervention compared to usual care alone within a cluster ...
Feasibility and Acceptability of an Agenda-Setting Kit in the ...
This article reports on a study to assess the feasibility of research procedures and acceptability of QBSAFE, a set of conversation cards focused on quality of ...
a pilot study testing an intervention to shift the paradigm ...
The end result is a greater burden of treatment, reduced capacity, and greater diabetes distress.
4.
pilotfeasibilitystudies.biomedcentral.com
pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00935-8Quality of life, burden of treatment, safety, and avoidance of ...
The authors aim to shift the paradigm of care for people with diabetes, to focus on quality of life, burden of treatment, safety, and avoidance of future ...
5.
academyhealth.confex.com
academyhealth.confex.com/academyhealth/2025arm/mediafile/Handout/Paper73802/QBSafe_AcademyHealth_poster_final.pdfQBSAFE: A Randomized Trial of a Novel Intervention to ...
Effective interventions are critically needed to align the encounter agenda with the needs of each patient, and to enable the co-creation of diabetes.
Study Details | NCT04514523 | QBSAfe: A Novel Approach ...
The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety. What is ...
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