← Back to Search

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
Participants diagnosed with DM2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
I have been diagnosed with type 2 diabetes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HbA1c at Month 6
Illness intrusiveness measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6
Secondary study objectives
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 study objectives
Clinician satisfaction survey
Patient satisfaction survey

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,924 Previous Clinical Trials
3,031,494 Total Patients Enrolled
11 Trials studying Diabetes
7,645 Patients Enrolled for Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,449 Previous Clinical Trials
4,332,303 Total Patients Enrolled
108 Trials studying Diabetes
138,513 Patients Enrolled for Diabetes
Kasia Lipska, MD MHSPrincipal InvestigatorYale University
1 Previous Clinical Trials
17 Total Patients Enrolled
1 Trials studying Diabetes
17 Patients Enrolled for Diabetes

Media Library

QBSafe Clinical Trial Eligibility Overview. Trial Name: NCT05553912 — N/A
Diabetes Research Study Groups: usual care, QBSafe intervention
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
~7 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top