# A Randomized Cross-Over Trial Evaluating Automated Insulin Delivery Technologies on Glycemic Outcomes and Quality of Life in Older Adults with Type 1 Diabetes

> **NIH NIH R01** · JAEB CENTER FOR HEALTH RESEARCH, INC. · 2021 · $638,470

## Abstract

Project Summary/Abstract
 Reducing hypoglycemia is an important aspect of management of type 1 diabetes in
older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both.
Clinical trials of existing automated insulin delivery systems have not included older adults in
sufficient numbers to allow for focused evaluation of efficacy and quality of life impacts that may
differ from those observed in younger age groups.
 The proposed research entitled “A Randomized Cross-over Trial Evaluating Automated
Insulin Delivery Technologies on Glycemic Outcomes and Quality of Life in Older Adults with
Type 1 Diabetes” aims to evaluate the effectiveness of 1) hybrid closed loop (HCL) technology
and 2) predictive low-glucose suspension (PLGS) on glycemic outcomes, QOL indicators and
usability compared with sensor-augmented pump (SAP) therapy, as well as evaluate the safety
of these technologies, in older adults with T1D. A secondary objective is to directly compare
HCL with PLGS on these same outcomes.
 These aims will be achieved via a multi-center, randomized, crossover trial, consisting of
three treatment arms over three 12-week periods, with the HCL treatment arm used during one
period, the PLGS treatment arm used during one period and SAP treatment arm (control) used
during one period. The crossover trial will be preceded by a run-in phase in which participants
will receive training on using the study devices. The randomized trial will include 90 individuals,
age at least 65 years old, with T1D for at least 1 year who have evidence of sensor measured
hypoglycemia during the baseline run-in. The primary outcome is percent of time spent with
glucose levels less than 70 mg/dl during each period. Other glycemic metrics, QOL
assessments and system usability will be secondary outcomes. Occurrences of severe
hypoglycemia, diabetic ketoacidosis, falls/fractures, emergency room visits, and hospitalizations
also will be assessed. Following the cross-over trial, participants will be given the opportunity to
use study devices for an additional 12 weeks to assess choice of system use (PLGS vs. HCL),
long-term durability and safety in a more real-world setting with less frequent study contacts.
 Thus, it is imperative to assess whether more advanced technologies involving
automation of insulin delivery can be successfully implemented into diabetes management of
older adults.

## Key facts

- **NIH application ID:** 10148768
- **Project number:** 5R01DK122603-03
- **Recipient organization:** JAEB CENTER FOR HEALTH RESEARCH, INC.
- **Principal Investigator:** Naomi Sage Chaytor
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $638,470
- **Award type:** 5
- **Project period:** 2019-07-25 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10148768

## Citation

> US National Institutes of Health, RePORTER application 10148768, A Randomized Cross-Over Trial Evaluating Automated Insulin Delivery Technologies on Glycemic Outcomes and Quality of Life in Older Adults with Type 1 Diabetes (5R01DK122603-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10148768. Licensed CC0.

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