NCT05553912Completed
QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
Glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. The investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. The investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 154 (actual)
- First submitted
- 21 Sept 2022
- Start date
- 2 Nov 2022
- Primary completion date
- 24 Feb 2025
- Lead sponsor
- Yale University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05553912
What you commit to
- Study type: Interventional
- Participants enrolled: 154
- From 2 Nov 2022 to the primary completion date, 24 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Participants for whom an HbA1c target >8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences
Who the study is looking for
- Clinicians
- any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (DM2) management (DM2) and prescribe medications for them
- Participants
- diagnosed with DM2
- able to sign informed consent
- fluent in either English or Spanish
- HbA1c >8%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fair Haven Community Health Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
Related publications
- Videographic Analysis of an Intervention to Improve Patient-Centered Care for People Living with Type 2 Diabetes: The QBSAFE Randomized Trial.J Gen Intern Med · 2026 · PMID 42834283
- A Conversation Tool to Enhance Care for People With Type 2 Diabetes: The QBSafe Cluster Randomized Clinical Trial.JAMA Netw Open · 2026 · PMID 42895748
- QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.medRxiv · 2026 · PMID 41728309
This page is information, not medical advice. Discuss any trial with your doctor.