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

> **NIH NIH R01** · KAISER FOUNDATION RESEARCH INSTITUTE · 2022 · $297,809

## Abstract

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 hyp...

## Key facts

- **NIH application ID:** 10492857
- **Project number:** 3R01AG068133-03S2
- **Recipient organization:** KAISER FOUNDATION RESEARCH INSTITUTE
- **Principal Investigator:** RICHARD W GRANT
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $297,809
- **Award type:** 3
- **Project period:** 2020-08-15 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10492857

## Citation

> US National Institutes of Health, RePORTER application 10492857, Administrative Supplement (PA-20-272) to Expand Safe Insulin De-Prescribing (R01 Award) to include Patients with ADRD and Their Caregivers (3R01AG068133-03S2). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10492857. Licensed CC0.

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