PROJECT SUMMARY/ABSTRACT
Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice
the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials
establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in more socially
advantaged and predominantly non-Hispanic white patients. Use of this transformative technology by individuals
with T1D from underserved communities remains very low. We plan to conduct a randomized effectiveness trial
- with broader eligibility criteria (including markedly elevated A1c) and longer (9 month) follow up than the pivotal
HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in underserved
adults with T1D (Specific Aim 1). Primary outcome will be % time-in-range 70-180 mg/dL, and secondary
outcomes will include % time < 70 mg/dL, DKA events and body weight. The HCL arm in the trial will include
three HCL systems (BetaBionics iLet, Insulet OP 5, Tandem Control IQ) that vary in degree of automation and
user input required for operation. More automated systems could potentially better match the needs of
underserved individuals with competing life demands that limit diabetes self-care; however, the potential benefits
of automation are at the cost of less personal control of the system, including adjustments for work-shift changes
and activity. Specific Aim 2 incorporates the novel application of Ecological Momentary Assessment to examine
the lived experience with HCL (including benefits and burdens, the impact of life stressors impact on HCL use,
and how the match between HCL system functionality and the individual’s needs and expectations impacts on
user experience). In Specific Aim 3, in collaboration with a user-centered designer, we will apply the learnings
from the study to develop: 1) Improved HCL patient education and clinician support tools; and 2) Decision-aids
to guide patient selection of the HCL system that is most aligned with personal preferences and needs. These
optimized training materials and decision-aids will set the stage for the translation of our research findings into
increased adoption of HCL in underserved communities and improved shared decision-making by patients and
clinicians in the selection of HCL systems.
