Abstract Body (Do not enter title and authors here): Introduction
Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) offer cardiovascular (CV) and kidney protective effects in patients with Type 2 DM (T2DM). Despite the benefits, these medications are underutilized due to various barriers. Remote management programs present a scalable solution to improve uptake of these medications in accordance with guidelines. However, safety concerns may limit the adoption of such programs. We report adverse effects (AEs) and safety outcomes in participants who initiated either medication class within a remote program.
Methods
The Diabetes Remote Intervention to improve the use of Evidence-based medications (DRIVE) Program was a randomized study conducted at Mass General Brigham (MGB), tertiary care medical center. The aim of study was to initiate SGLT2i or GLP-1 RA in T2DM patients with or at higher risk of CV and/or kidney complications. A total of 200 participants were enrolled in 2-months of Education-first or Simultaneous Education and medications initiation arm, with 106 starting SGLT2i or GLP-1 RA treatment within six months of enrollment. Study staff regularly contacted participants who were initiated on either medication to assess AEs and safety outcomes.
Results
Of 68 participants who started on an SGLT2i, 35 (51.5%) experienced any AE, 8 (11.8%) had a genitourinary AE and 7 (10.3%) experienced an AE that led to discontinuation of drug. Of 40 participants who started on a GLP-1 RA, 22 (55.0%) experienced any AE, 19 (47.5%) had a gastrointestinal AE and 4 (10.0%) experienced an AE that led to discontinuation of drug. Nearly all medication-related AEs were managed by DRIVE program clinicians independently or in collaboration with participant’s outpatient clinical team.
Conclusion
The DRIVE program safely initiated and managed SGLT2i or GLP-1 RA treatment in participants. The rates of AEs observed were comparable to those reported in clinical trials, supporting the scalability, effectiveness, and safety of remote initiation and management of these drugs. Furthermore, AEs from these medications can be successfully managed remotely by a clinical team in conjunction with participants’ primary providers.