Inpatient safety, effectiveness of SGLT2 inhibitors and GLP-1 RAs in type 2 diabetes: ENDOCARE, a pragmatic prospective cohort study
Abstract
BACKGROUND: Current guidelines recommend baseline insulin as the standard treatment for most people hospitalised with type 2 diabetes (PWT2D). However, they generally discourage the use of sodium–glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists due to safety concerns and a lack of randomised evidence. We aim to assess primarily safety, and secondarily, effectiveness of non-insulin glucose-lowering therapy for inpatients, as implemented within a structured start-stop clinical practice guideline. METHODS: We conducted a 9-month pragmatic prospective cohort study including PWT2D adults who were admitted to the medical and surgical wards of a tertiary hospital. Participants were managed either on oral antidiabetic drugs (with or without insulin) under a start–stop protocol (Group A) or with insulin-only therapy (Group B). The primary outcome was safety, defined as severe adverse events (level 2–3 hypoglycaemia or diabetic ketoacidosis). Secondary outcomes included median daily capillary glucose and glycaemic variability. Hospital stay, intensive care unit admission and mortality were exploratory outcomes. Multivariable logistic regression and propensity score matching were employed to adjust for confounding factors. RESULTS: A total of 979 participants were included in the study: 582 in the Group A and 397 in the Group B. Seventy-three severe adverse events occurred, primarily hypoglycaemia. Non-insulin therapy was independently…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 979 participants or records.
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