NCT04514523: QBSAfe

QBSAfe: A Novel Approach to Diabetes Management Focused on Quality of Life, Burden of Treatment, Social Integration and Avoidance of Future Events

Completed NA Results posted Last updated 6 January 2023

What this trial tests

NA trial testing QBSAfe Toolkit in Diabetes in 91 participants. Completed in 22 September 2020.

Timeline

28 April 2020

Primary endpoint
22 September 2020

22 September 2020

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	91
Start date	28 April 2020
Primary completion	22 September 2020
Estimated completion	22 September 2020
Sites	3 locations across United States

Drugs / interventions tested

• QBSAfe Toolkit

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Yale University

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability - Patients Primary · Baseline [Post Clinical Encounter]

Patient responses to post-visit questionnaires.

These cards helped me talk about my situation during my visit

Group	Value	95% CI
Single-Arm Intervention Group	16
Single-Arm Intervention Group	21
Single-Arm Intervention Group	12
Single-Arm Intervention Group	6

I would like to have these cards available to me at my next visit

Group	Value	95% CI
Single-Arm Intervention Group	12
Single-Arm Intervention Group	10
Single-Arm Intervention Group	21
Single-Arm Intervention Group	12

I believe other patients like me would benefit from these cards

Group	Value	95% CI
Single-Arm Intervention Group	19
Single-Arm Intervention Group	26
Single-Arm Intervention Group	9
Single-Arm Intervention Group	3

Acceptability - Clinicians Primary · Baseline [Post Clinical Encounter]

Clinician responses to post-visit questionnaires.

I felt confident in responding to issues raised by the patient

Group	Value	95% CI
Single-Arm Intervention Group	48
Single-Arm Intervention Group	14
Single-Arm Intervention Group	4
Single-Arm Intervention Group	3

I would like to use these cards with a patient like this next time

Group	Value	95% CI
Single-Arm Intervention Group	43
Single-Arm Intervention Group	11
Single-Arm Intervention Group	14
Single-Arm Intervention Group	1

I would recommend these cards to my colleagues

Group	Value	95% CI
Single-Arm Intervention Group	46
Single-Arm Intervention Group	10
Single-Arm Intervention Group	11
Single-Arm Intervention Group	1

Feasibility 1 Secondary · Baseline [Post Clinical Encounter]

Percentage of participants who completed the study procedures.

Group	Value	95% CI
Single-Arm Intervention Group - Patients	58
Single-Arm Intervention Group - Clinicians	7

Feasibility 2 Secondary · Baseline [Post Clinical Encounter]

Percentage of recorded visits in which the QBSAFE toolkit was used assessed by Number of visits QBSAFE was used/Number of recorded visits.

Group	Value	95% CI
Implementation Arm	58

Feasibility 3 Secondary · Baseline [Post Clinical Encounter]

Time to recruit 84 subjects across 3 sites.

Group	Value	95% CI
Implementation Arm	145

Sponsor's own description

The purpose of this study is to co-develop a toolkit (known as the QBSAfe toolkit) with patients, family caregivers, and clinicians that focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety for patients with diabetes mellitus.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care.
   Clark JE, Boehmer KR, Breslin M, Haider S, et al · · 2021 · cited 2× · PMID 34749816 · DOI 10.1186/s40814-021-00935-8
2. Applications and prospects of biomaterials in diabetes management.
   Guan W, Zhang L. · · 2025 · PMID 40124248 · DOI 10.3389/fbioe.2025.1547343
3. Feasibility and Acceptability of an Agenda-Setting Kit in the Care of People With Type 2 Diabetes: The QBSAFE ASK Feasibility Study.
   Haider S, Gonzalez-Lopez C, Clark J, Gravholt DL, et al · · 2024 · PMID 39015172 · DOI 10.2337/cd23-0062