# QBSafe: A novel approach to care for older, complex adults with type 2 diabetes

> **NIH NIH R21** · YALE UNIVERSITY · 2020 · $204,072

## Abstract

PROJECTS SUMMARY/ABSTRACT
One in five Americans over the age of 75 (~4 million people) has type 2 diabetes and this population is
expected to double over the next 25 years. About half of these oldest patients have multiple comorbidities and
functional impairments, and the vast majority has one or more geriatric conditions. As a result, glycemic
management in this population is challenging. Multiple chronic conditions and impairments make it challenging
to self-manage complex tasks (such as insulin administration and dosing), leave patients overwhelmed and
overburdened by the work required to manage their conditions, and increase the risk of adverse events (such
as hypoglycemia). To shift the paradigm of care for this population – from the narrow focus on reaching
hemoglobin A1c targets to prioritizing patient-centered goals – we propose to develop and test the QBSafe
protocol. QBSafe will focus on maximizing Quality of life (reducing the burden of symptoms), optimizing the
Burden of treatment (medication administration, costs, and monitoring), and improving treatment Safety
(reducing adverse effects, such as hypoglycemia). Utilizing our experience with stakeholder engagement in
research, we propose to assemble a working group of patients, caregivers, and clinicians to co-develop the
QBSafe protocol of care. Next, we propose to pilot test QBSafe in a single-arm feasibility two-site study and
examine the extent to which QBSafe (a) can be embedded within clinical practice routines (using Normalization
Process Theory and its Toolkit); (b) affects quality of life, treatment burden, and hypoglycemia risk 6 months
after implementation (using validated measures); (c) affects clinician satisfaction with diabetes care; and (d) is
ready for testing in a large multicenter randomized trial. To maximize chances of success, our team brings
together experience and expertise in diabetes and aging, minimally disruptive medicine, prevention of
hypoglycemia, stakeholder engagement in research, design and testing of interventions in randomized trials,
and evaluation of factors that promote or hinder the adoption of innovations in routine clinical care. If
successful, QBSafe will offer a novel alternative diabetes care strategy for patients with type 2 diabetes since
the demonstration of the glycemic hypothesis and the institutionalization of hemoglobin A1c-based care 25
years ago. This work will set the stage for a randomized trial to compare the impact of the intervention on
quality of life, treatment burden, and adverse events when compared with usual clinical guideline-directed care,
i.e., targeting hemoglobin A1c level <8% for older, complex adults with type 2 diabetes. A larger, longer clinical
trial will examine tradeoffs associated with QBSafe approach that may emerge over a longer time-frame.

## Key facts

- **NIH application ID:** 9844058
- **Project number:** 5R21AG061427-02
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Kasia Joanna Lipska
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $204,072
- **Award type:** 5
- **Project period:** 2019-01-15 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9844058

## Citation

> US National Institutes of Health, RePORTER application 9844058, QBSafe: A novel approach to care for older, complex adults with type 2 diabetes (5R21AG061427-02). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/9844058. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*