QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Type2Diabetes
• Intervention / Treatment: Behavioral: QBSafe

Detailed Description

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 randomized clinical trial among patients with type 2 diabetes.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Fair Haven Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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%

Exclusion Criteria:

• Participants for whom an HbA1c target >8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care
Experimental: QBSafe intervention	Behavioral: QBSafe; an intervention comprised of (a) a set of conversation cards (QBSafe ASK) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c at Month 6	HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score.	Month 6
Illness Intrusiveness Measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6	The change in illness intrusiveness measured by the validated Illness Intrusiveness Ratings Scale (IIRS). IIRS is comprised of 13 items that ask participants to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Overall score is calculated by summing the 13 items creating a value between 13 to 91, where higher scores indicate increased illness intrusiveness. Analysis will assess the 6 months response as the outcome adjusting for arm and the initial score. Subscales are scored 1-7 with higher scores indicating more disruption or intrusiveness.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Distress Will be Measured Using the Diabetes Distress Scale (DDS-17) at Month 6	The DDS is a validated 17-item self-report instrument where each item is rated on a 6-point Likert scale from (0) "not a problem" to (6) "a serious problem." The scale yields a total DDS score, plus scores for 4 subscales: emotional burden, regimen distress, physician distress, and interpersonal distress. Total and subscale scores are calculated using mean item scores, which are then categorized as little or no distress (0- 2.0), moderate distress (greater than or equal to 2.0 and less than or equal to 2.9) and high distress (3.0-6.0). Moderate and high distress are considered 'clinically significant.'	Month 6
Treatment Burden Will be Assessed Using the Treatment Burden Questionnaire (TBQ) at Month 6	The TBQ is a self-reported questionnaire assessing the burden of treatment without restricting its scope to a single condition or treatment context. It is composed of 15 items rated on a Likert scale ranging from 0 (no impact) to 10 (considerable impact) related to the burden associated with taking medicine, self-monitoring, laboratory tests, physician visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. Item scores can be summed into a global score, ranging from 0 to 150. Higher scores reflect higher treatment burden.	Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Communication Assessed Using 3 Questions From the CAHPS Clinician and Group Survey	The quality of communication will be assessed with a modified version of 3 questions from the CAHPS Clinician and Group survey. These questions indicate the extent to which the communication is patient-centered, covering technical (explain things in a way you could understand) and affective (show respect for what you have to say) communication.	up to 6 months
Hypoglycemia Measured at Month 6	Hypoglycemia will be measured by asking participants about the frequency of any hypoglycemia (defined by a glucose level below 70 mg/dl [Level 1 hypoglycemia] or symptoms consistent with hypoglycemia), any blood glucose level below 54 mg/dl (Level 2 severe hypoglycemia), or any hypoglycemia requiring assistance from another person to treat.	Month 6
Quality of Life Was Assessed Using the Visual Analogue Scale (VAS) at Month 6.	To assess global quality of life, a single-item VAS survey will be used with scale ranging from 0 (worst possible)-to-100 (best possible).	Month 6
Patient Satisfaction Survey	Patients will rate their satisfaction with the approach used during the encounter on a 5-point Likert scale, which could have been usual care alone or usual care with the QBSafe ASK.	up to 6 months
Clinician Satisfaction Survey	Clinicians will rate their satisfaction with the approach used during the encounter on a 5-point Likert scale, which could have been usual care alone or usual care with the QBSafe ASK.	up to 6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kasia Lipska, MD MHS, Yale University

Publications and helpful links

General Publications

• Lipska KJ, Branda ME, Camp AW, Montosa M, McCoy RG, Montori V, Larios F, Montori VM. QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes. medRxiv [Preprint]. 2026 Feb 9:2026.02.06.26345768. doi: 10.64898/2026.02.06.26345768.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HbA1c; A1c
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2000032654; 1R01DK129616-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No