Study design and population
diabetes, cancer, T2D, RA
CANCER, PCP, DIABETES
This was a pilot, parallel‐group randomized controlled trial (RCT) feasibility study in adults with newly diagnosed cancer and undiagnosed or untreated T2D to test a nurse‐led 3‐month intervention for managing T2D. The study took place from November 2020 to November 2021, with a pause due to COVID‐19 restrictions and research assistant (RA) training from December 2020 to April 2021. The extensive RA training was conducted by the primary investigator, a nurse with expertise in T2D, and consisted of, among other topics, informed consent, T2D education, and point‐of‐care (POC) HbA1c testing based upon study protocol. Patients were first prescreened using the electronic health record (EHR) and then screened in‐clinic at an academic‐affiliated outpatient oncology clinic We planned to screen approximately 800 adults and recruit a sample of up to 40 with a goal of retaining 32 subjects (≥80%). This sample size would have sufficient power (80%) to detect a Type I error of 0.05 with an effect size of 1. No interim analysis was planned.Participants meeting the prescreening criteria (Table The nurse‐led 3‐month intervention consisted of diabetes education and standard metformin initiation. Participants received information on how to take metformin using a standardized titration protocol, potential side effects of metformin, and how to measure their blood glucose levels using a glucometer. Prescriptions for both metformin as well as a blood glucose testing kit were given to participants. The oncology visit note, HbA1c testing results, and study enrollment status were relayed to the participant's PCP. Participants were contacted by a nurse weekly by phone for the first month and then once monthly for 2 months to monitor metformin use, potential side effects, and answer any questions. Phone calls lasted approximately 15 min. Participants were also asked for a pill count to monitor medication adherence and their blood glucose logbook was reviewed.Participants in the usual care group were referred to a PCP for T2D management. The oncology visit note and HbA1c testing results were relayed to the participant's PCP. Participants were contacted weekly by phone for the first month and then once monthly for 2 months to discuss their status. The trial was registered in 