FDA Draft Guidance on T2D Devices; New GLP-1 Drug Succeeds in Trial

The FDA issued new draft guidance regarding early studies on medical devices for type 2 diabetes, accepting online comments through July 20. “With our focus on improving public health and making technologies available that can help improve the quality of life for those with chronic diseases like type 2 diabetes, we’re interested in getting feedback from manufacturers as well as the diabetes community on this draft guidance,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in a statement.

The investigational GLP-1 receptor agonist tirzepatide significantly reduced HbA1c levels and body weight in people with type 2 diabetes with a higher cardiovascular risk compared with titrated insulin glargine in the 52-week SURPASS-4 clinical trial, Eli Lilly announced.

The phase IIb DIAGNODE-2 trial found intralymphatic glutamic acid decarboxylase (GAD-alum, Diamyd) injections combined with vitamin D supplementation helped to preserve serum C-peptide mean area under the curve in patients newly diagnosed with type 2 diabetes carrying HLA DR3-DQ2. (Diabetes Care)

Ascensia Diabetes Care unveiled a new online diabetes management platform, GlucoContro.online, to track blood glucose information and share it between patients and providers. (FierceBiotech)

Among postmenopausal women, social isolation and loneliness can increase the risk for cardiovascular disease by 29%, according to a new study presented at the virtual American Heart Association Epidemiology, Prevention, Lifestyle & Cardiometabolic Health Conference.

The European Society of Endocrinology released an updated position statement on the intersection between COVID-19 and endocrine conditions. “[I]n view of the mass vaccination, potential implications for endocrine patients should be considered,” authors of the statement wrote. (Endocrine)

The interleukin-6 inhibitor ziltivekimab slayed biomarkers of inflammation related to atherosclerosis in patients with chronic kidney disease, comorbid cardiovascular disease, and elevated high-sensitivity C-reactive protein levels. Findings were published in The Lancet and simultaneously presented at the American College of Cardiology’s virtual meeting.

A study in a Puerto Rican cohort found that prenatal exposure to the herbicide glyphosate — the active ingredient in Roundup — was tied to an increased risk of preterm birth. (Environmental Health Perspectives)