143 Participants Needed

QBSafe for Type 2 Diabetes

VM
KL
Overseen ByKasia Lipska, MD MHS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

KL

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

Participants able to sign informed consent
I am a healthcare professional involved in managing type 2 diabetes.
I have been diagnosed with type 2 diabetes.
See 1 more

Exclusion Criteria

My doctor and I agree that an HbA1c target above 8% is suitable for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the QBSafe intervention or usual care for up to 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+
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