Administrative Supplement (PA-20-272) to Expand Safe Insulin De-Prescribing (R01 Award) to include Patients with ADRD and Their Caregivers

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PROJECT SUMMARY Iatrogenic hypoglycemia due to prescribed medications (e.g., insulin and sulfonylureas) is the single greatest management-related problem facing older patients with type 2 diabetes (T2D). These hypoglycemic events are associated with a 1.7-fold increased risk of fall-related fractures, a 2-fold risk of serious cardiovascular events, and a 3-fold increased risk in mortality. Hypoglycemia is an even greater problem for individuals with Alzheimer’s disease and its related dementias (ADRD), which affects nearly 1 in 4 of the nearly 9 million adults with T2D aged ≥ 75 years. Older adults with ADRD have 3-fold increased odds of severe hypoglycemia requiring hospitalization compared to older adults without ADRD. In Aim 1 of the Parent R01 (R01AG068133: Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia; 8/15/2020 - 4/30/2025) we created Prepare for Your Diabetes Care – a patient-facing web-based platform that helps patients prepare for and engage in effective conversations with their provider about their current diabetes medicines. In Aim 2 of the Parent award, we are conducting a randomized clinical trial (RCT) to measure the impact of this intervention on diabetes medication de- prescribing and hypoglycemic events among patients ≥ 75 years with tightly controlled diabetes prescribed insulin and/or sulfonylureas. However, we excluded patients with ADRD. New strategies must engage patients with early ADRD and mild-to-moderate cognitive impairment (MCI) prior to the loss of decision-making capacity. Strategies must also prepare patients’ caregivers. Therefore, in the current Administrative Supplement (PA-20-272), we propose to leverage our existing Prepare for Your Diabetes Care intervention and the Parent clinical trial infrastructure to include high-risk patients with T2D and early ADRD/MCI and their caregivers. In Supplemental Aim 1, we will determine the feasibility and acceptability of the Parent RCT protocol in high-risk older adults with T2D and early ADRD/MCI and their caregivers, and in Aim 2 we will identify barriers and tailoring strategies to enable patients/caregivers to effectively use Prepare for Your Diabetes Care. Based on prior work in patients with early ADRD/MCI and caregivers, we estimate needing to recruit 150 dyads to enroll 30. We will assess standard recruitment and retention metrics (for trial planning), and acceptability and usability metrics and qualitative feedback (for intervention modification). A specific innovative strength of this proposed Supplement is our focus on how to better incorporate the role of caregivers in the process of care planning related to safe diabetes medication de-prescribing in high-risk patients with ADRD and MCI. These Aims are well within the scope of the Parent award and will lead to a future R01-funded RCT of older adults with ADRD/MCI and their caregivers in de-prescribing to prevent hypoglycemia.