Implementation of a diabetes navIgator to Mitigate disPArities and improve CGM upTake and sustained use across the lifespan of T1D (IMPACT T1D)

NIH RePORTER · NIH · R01 · $327,402 · view on reporter.nih.gov ↗

Abstract

Project Summary Type 1 diabetes (T1D) is a chronic disease that requires intensive daily management to maintain adequate glycemic control and prevent diabetes-related complications. Less than 20% of individuals meet the American Diabetes Association goal hemoglobin A1c level for adequate glycemic control. Use of diabetes technologies, and specifically continuous glucose monitors (CGMs), are the standard of care, and improve glycemic control, health related quality of life and treatment satisfaction. Despite these benefits, CGMs are underutilized, particularly in minorities and individuals from underserved communities. Increasing uptake and continued use of CGM can help improve glycemic control and mitigate disparities in diabetes-related outcomes for underserved individuals. There are many barriers to CGM use at the patient, provider and systems levels, yet there are no proven interventions to address these barriers. In a pilot study at our institution, we demonstrated that placement of trial CGM with standardized education at the point of care increases CGM uptake, but overcoming the knowledge barrier is insufficient to ensure personal and sustained use of CGM. The objective of this project is to build upon our pilot study to implement a novel intervention in the real-world clinical setting that is feasible, sustainable and generalizable to increase CGM uptake across the lifespan - including pediatric, emerging adults, and adults with T1D. We hypothesize that implementing the support of a diabetes navigator with trial CGM placement at the point of care will increase CGM uptake and sustained use, leading to improvements in glycemic control that will mitigate disparities in diabetes related outcomes for underserved individuals with T1D. In this proposal, we will first (Aim 1) refine the role and toolkit of the diabetes navigator based on stakeholder feedback on solutions to address barriers to CGM uptake and sustained use. Building on the experience from our pilot study, the formative phase of Aim 1, and leveraging the collective expertise of our multidisciplinary study team, we will conduct a randomized controlled trial (Aim 2) of 136 individuals with T1D, including 60 children and adolescents and 76 adults, not currently using CGM. Participants will be randomized to (Arm 1) standard of care trial CGM placement (n=68), or (Arm 2) the intervention arm with trial CGM placement with the support from a diabetes navigator (n=68). We hypothesize that the diabetes navigator arm will have higher CGM uptake and sustained use, with (Aim 3) greater improvements in glycemic control and patient-related outcomes, compared to the standard of care arm. If the diabetes navigator is successful in increasing CGM uptake and sustained use, and is demonstrated to be a feasible, acceptable and sustainable intervention that can be applied to the larger diabetes community, it has the potential to improve diabetes care and mitigate disparities in diabetes related outco...

Key facts

NIH application ID
10582073
Project number
1R01DK134955-01
Recipient
JOHNS HOPKINS UNIVERSITY
Principal Investigator
NESTORAS N MATHIOUDAKIS
Activity code
R01
Funding institute
NIH
Fiscal year
2022
Award amount
$327,402
Award type
1
Project period
2022-09-21 → 2026-07-31