Type2DiabetesNCT05553912
QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
A study testing QBSafe in people with Type2Diabetes and Diabetes, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2Diabetes, Diabetes
- What is being tested?
- QBSafe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Participants for whom an HbA1c target >8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences
Trial locations and contacts
1 site in 1 country.
United States1 site
Fair Haven Community Health Center
New Haven, Connecticut, 06510
About this study
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.
Read the 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.
- Conditions
- Type2Diabetes, Diabetes
- Being tested
- QBSafe
- Keywords
- A1c, HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBSafeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| QBSafe intervention | Experimental | Not described Receives: Behavioral: QBSafe |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
HbA1c at Month 6
HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score.
Measured: Month 6
Secondary outcomes (2)
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.'
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start2 Nov 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized clinical trial of usual care with a behavioral intervention (use of conversation cards during routine clinical encounters) compared with usual care alone. The study will randomize 10-15 clinicians and 72 of their patients with type 2 diabetes to each arm. Data collected includes medical record data, patient and clinician surveys, and audio-visual recordings of clinical encounters.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasia Lipska, MD MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553912
- Sponsor's protocol ID
- 2000032654
- Other IDs
- 1R01DK129616-01A1
- Status last verified
- Jul 2026
- First submitted
- 21 Sep 2022
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lipska KJ, Branda ME, Camp AW, Montosa M, McCoy RG, Montori VV, Larios F, Montori VM. A Conversation Tool to Enhance Care for People With Type 2 Diabetes: The QBSafe Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639032. doi: 10.1001/jamanetworkopen.2026.39032.
PubMed 42895748Montori V V, Larios F, Bandi SSS, Proano AC, Guevara K, Vilatuna L, Bagewadi S, van Gastel A, Branda ME, Camp AW, Montosa M, McCoy RG, Montori VM, Lipska KJ. 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 Oct 5. doi: 10.1007/s11606-026-10849-x. Online ahead of print.
PubMed 42834283Lipska 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.
PubMed 41728309
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QBSafe: a Randomized Trial of a Novel Intervention to Improve Care for People Living With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT05553912
- Acronym / sponsor ID
- 2000032654
- Conditions
- Type2Diabetes, Diabetes
- Keywords
- A1c, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Posted 6 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster randomized clinical trial of usual care with a behavioral intervention (use of conversation cards during routine clinical encounters) compared with usual care alone. The study will randomize 10-15 clinicians and 72 of their patients with type 2 diabetes to each arm. Data collected includes medical record data, patient and clinician surveys, and audio-visual recordings of clinical encounters.
| Arm | Type | Receives |
|---|---|---|
| QBSafe intervention | Experimental | Behavioral: QBSafe |
| usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Participants for whom an HbA1c target >8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QBSafean 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. | Behavioural | QBSafe intervention |
Primary outcome
Illness Intrusiveness Measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6
Time frame: 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.
HbA1c at Month 6
Time frame: Month 6
HbA1c value at month 6. Analysis will model the 6 month HbA1c assessment adjusting for arm and the initial score.
2 secondary outcomes
Diabetes Distress Will be Measured Using the Diabetes Distress Scale (DDS-17) at Month 6
Time frame: Month 6
Treatment Burden Will be Assessed Using the Treatment Burden Questionnaire (TBQ) at Month 6
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42895748Lipska KJ, Branda ME, Camp AW, Montosa M, McCoy RG, Montori VV, Larios F, Montori VM. A Conversation Tool to Enhance Care for People With Type 2 Diabetes: The QBSafe Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639032. doi: 10.1001/jamanetworkopen.2026.39032.
- Derived from this study: PubMed 42834283Montori V V, Larios F, Bandi SSS, Proano AC, Guevara K, Vilatuna L, Bagewadi S, van Gastel A, Branda ME, Camp AW, Montosa M, McCoy RG, Montori VM, Lipska KJ. 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 Oct 5. doi: 10.1007/s11606-026-10849-x. Online ahead of print.
- Derived from this study: PubMed 41728309Lipska 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasia Lipska, MD MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QBSafe in people with Type2Diabetes and Diabetes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness Intrusiveness Measured by the Illness Intrusiveness Ratings Scale (IIRS) at Month 6 (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553912, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.