Care partner-assisted ImplementatiOn of Patch HybrId Closed Loop Insulin Delivery for Older Adults with T1D (COPILOT)

RESPONSE: Diabetes technology, including continuous glucose monitoring (CGM), insulin pumps, and hybrid closed loop (HCL), is the gold standard for improving outcomes for patients with T1D. Recently, the consortium applying to this NOFO completed a randomized, crossover, automated insulin delivery in elderly (AIDE) trial, which demonstrated that older adults with T1D can safely use HCL and improve HbA1c with less hypoglycemia. Despite these promising results, a significant proportion of older adults with T1D are not considered for HCL therapy because of an inability to independently manage their diabetes due to cognitive impairment. “How can technology be harnessed for older people with special needs with cognitive or functional deficits” has been recognized as a crucial knowledge gap in a key consensus paper (PMID: 32946822). Yet, there currently exist no data to support HCL use in this complex and important population. It has been said that "the contribution of closed-loop technology to diabetes management will depend less on technological factors than on 'the real-life interactions between people and technology' including clinicians, family members, as well as people with diabetes themselves.” We propose research to assess the feasibility and acceptability of implementing a patch HCL system in older adults with cognitive impairment who require additional support from a "care partner." Before the intervention phase begins, we will conduct necessary formative research to anticipate barriers to successful HCL adoption and sustained use via a series of focus groups. Results will inform tailored training materials and protocols. In the intervention phase, we will enroll 54 cognitively and functionally impaired (i.e., cannot manage T1D independently) older adults with T1D alongside their 54 care partners, over 3 months of follow-up. Patient participants and care partners will proceed to the CGM run-in Phase, followed by tailored training on study patch pump integrated with CGM by clinic study staff. Glycemic management based on HbA1c and CGM metrics will be studied at pre-specified time points, alongside patient-reported, and care partner-reported, psychosocial outcomes, including burden. An important feasibility outcome is the ability to implement/evaluate treatment strategies across multiple clinics; three sites will be used in COPILOT. We will conduct a mixed-methods intervention evaluation to complement the outcomes by characterizing the key contextual factors and additional resources needed to scale an efficacious intervention in this vulnerable cohort. Findings from COPILOT will inform, for the first time, effects of and strategies required to implement HCL in older adults with T1D who are not independent in their self-care due to moderate-severe cognitive impairment.