American heart journalJan 29, 2026

Safety of a remote program to increase use of diabetes medicines linked to heart and kidney health in type 2 diabetes

GLP-1 Therapies Weekly Brief ↗PubMed ↗DOI ↗

Updated Feb 1, 2026

Abstract

Of 200 participants enrolled, 53% initiated SGLT2 inhibitors or GLP-1 receptor agonists.

Among SGLT2 inhibitor users, 29.4% reported an adverse event, with genital mycotic infections and symptoms of volume depletion being the most common.
10.3% of SGLT2 inhibitor users discontinued treatment due to adverse events.
55.0% of GLP-1 receptor agonist users experienced adverse events, primarily gastrointestinal issues.
10.0% of GLP-1 receptor agonist users discontinued treatment due to adverse events.
No cases of severe hypoglycemia, emergency department visits, or hospitalizations were reported during the study.

Simplified

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1 RA) reduce cardiovascular and kidney risk in patients with type 2 diabetes (T2D), yet real-world use remains suboptimal. Remote care models offer a promising approach to improve access; there is limited data on the safety of and adverse events (AEs) associated with prescribing and titrating these therapies through a protocol-driven remote management program.

METHODS: The DRIVE trial was a pragmatic, randomized clinical trial evaluating the safety of a remote disease management program that initiated SGLT2i and/or GLP1 RA in patients with T2D and elevated cardiovascular or kidney risk. Participants were enrolled at a large integrated health care system in Massachusetts between March 2021 and December 2022. Participants were randomized to one of two implementation strategies: a sequential approach (two months of education first followed by medication initiation) or a bundled approach (simultaneous education and medication initiation). Non-clinical navigators and clinical pharmacists, supervised by physicians, oversaw medication initiation and monitoring under a collaborative drug therapy management agreement and protocol that included algorithms for initiation and titration of SGLT2i and GLP1 RA, as well as adjustment of concurrent glucose-lowering medications to reduce the risk of hypoglycemia Safety outcomes were collected through chart review and patient report, including targeted AEs, hospitalizations, emergency department visits, and urgent care visits. Targeted AEs were prospectively collected over the first six months after enrollment: for SGLT2i initiators, symptoms of genital mycotic infection, urinary tract infection, or volume depletion; for GLP 1 RA initiators, nausea, vomiting, diarrhea, and abdominal pain. Hospitalizations, emergency department visits, and urgent care visits over the first six months after enrollment were retrospectively collected through electronic health record review.

RESULTS: Of 200 participants enrolled, 106 (53%) initiated SGLT2i (n=68) or GLP1 RA (n=40). Among SGLT2i users, 29.4% reported an AE, most commonly genital mycotic infections (10.3%) and symptoms of volume depletion (11.8%); 10.3% discontinued due to AEs. Among GLP1 RA users, 55.0% experienced AEs, predominantly gastrointestinal; 10.0% discontinued due to AEs. No severe hypoglycemia, emergency department visits, or hospitalizations occurred.

CONCLUSIONS: A remote, pharmacist- and navigator-led program safely initiated SGLT2i and GLP1 RA in a high-risk T2D population, with AE rates comparable to clinical trials and high persistence. These findings support the feasibility of remote prescribing with appropriate clinical oversight and structured AE management.

TRIAL REGISTRATION: Registry: ClinicalTrials.gov; URL: https://clinicaltrials.gov/study/NCT06046560; unique identifier: NCT06046560.

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Conflicts of interest Lee-Shing Chang: Applied Therapeutics, Better Therapeutics, Boehringer Ingelheim, Corcept Therapeutics, Eli Lilly, Fractyl Health, Novo Nordisk, Rhythm Pharmaceuticals, Sanofi; Shahzad Hassan: Supported by the National Institutes of Health grant T32HL007604; Jacqueline Chasse, Gretchen Stern, Caitlin Colling, Daniel Gabovitch, David Zelle, Jennifer Crossen, Christian Figueroa, Emma Collins, Ryan Ruggiero, Michael Oates: None; Samuel Aronson: Research Grants via Brigham and Women’s Hospital – Better Therapeutics, Boehringer Ingelheim, NovoNordisk and via Mass General Brigham: NIH. Consultant: Nest Genomics; Jorge Plutzky: Grant support Boehringer Ingelheim; Consultant: Janssen, Novo Nordisk; Thomas Gaziano: AstraZeneca, Novartis, Multiply Labs; Christopher Cannon: Research Grants – Amgen, Better Therapeutics, Boehringer Ingelheim, Daiichi Sankyo, Merck, Novo Nordisk, Pfizer; Consulting – Amryt/Chiesi, Alnylam, Amarin, Amgen, Applied Therapeutics, Ascendia, Biogen, Boehringer Ingelheim, Bristol Myers-Squibb, CSL Behring, Eli Lilly, Janssen, Lexicon, Merck, Milestone, Pfizer, Rhoshan, Sanofi; Deborah Wexler: Novo Nordisk; Alexander J. Blood: Research Grants – Astra Zeneca, Boehringer Ingelheim, Novo Nordisk, Eli Lilly, General Electric Health, Merck; Consulting – Medscape, Novo Nordisk, Milestone Therapeutics, Walgreens, Color Health, Arsenal Capital Partners; Equity – AIwithCare, Knownwell, Porter Health; Benjamin M. Scirica: Research Grants – Better Therapeutics, Boehringer Ingelheim, Merck, NovoNordisk, and Pfizer. Consulting – Abbvie (DSMB), AstraZeneca (DSMB), Boehringer Ingelheim, Better Therapeutics, Bristol Myers-Squibb, Elsevier Practice Update Cardiology, Esperion, Hanmi (DSMB), Lexeo (DSMB), Lexicon, NovoNordisk; Equity – Health [at] Scale and Doximity.

PubMed

Safety of a remote program to increase use of diabetes medicines linked to heart and kidney health in type 2 diabetes

Abstract

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Competing interests

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