Background Oral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment. Methods This randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1•73 m², and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible. Participants were randomly assigned (1:1) by use of an interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo for 26 weeks, in addition to background medication. Participants and site staff were masked to assignment. Two efficacy-related estimands were defined: treatment policy (regardless of treatment discontinuation or rescue medication) and trial product (on treatment without rescue medication) in all participants randomly assigned. Endpoints were change from baseline to week 26 in HbA1c (primary endpoint) and bodyweight (confirmatory secondary endpoint), assessed in all participants with sufficient data. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered on ClinicalTrials.gov, number NCT02827708, and the European Clinical Trials Registry, number EudraCT 2015-005326-19, and is now complete.
Purpose
The coronavirus disease 2019 (COVID-19) pandemic has had an immense impact on the healthcare industry. Oral and maxillofacial surgery (OMS) clinical practice uniquely exposes providers to COVID-19. The purpose of the present study was to understand the effect of the COVID-19 pandemic on OMS residency training programs (OMSRTPs):
1)
training and education;
2)
availability and use of personal protective equipment (PPE);
3)
experience with, and use of, screening and viral testing;
4)
resident experience; and
5)
program director (PD) experience and observations of the immediate and future effects on OMSRTPs.
Materials and Methods
OMS residents and PDs in OMSRTPs in the United States were invited to participate in the present cross-sectional study from April 1, 2020 to May 1, 2020. A 51-question survey was used to evaluate the effects of COVID-19 on OMSRTPs and to assess the 5 specific aims of the present study.
Results
A total of 160 residents and 13 PDs participated in the survey, representing 83% of US states or territories with OMSRTPs. Almost all residents (96.5%) reported modifications to their training program, and 14% had been reassigned to off-service clinical rotations (eg, medicine, intensive care unit). The use of an N95 respirator mask plus standard PPE precautions during aerosol-generating procedures varied by procedure location, with 36.8% reporting limited access to these respirators. Widespread screening practices were in use, with 83.6% using laboratory-based viral testing. Residents scheduled to graduate in 2022 were most concerned with the completion of the graduation requirements and with decreased operative experience. Most residents (94.2%) had moved to web-based didactics, and a plurality (47%) had found increased value in the didactics.
Conclusions
Sweeping alterations to OMS clinical practice have occurred for those in OMSRTPs during the COVID-19 pandemic. Although the overall OMSRTP response has been favorable, residents' concerns regarding the ubiquitous availability of appropriate PPE, operative experience, and completion of graduation requirements requires further deliberation.
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