News in brief: Urgent defect warning for popular CGM device;  Insulin-treated diabetes linked to higher PCI risk; New obesity guidelines needed 


Urgent defect warning for popular CGM device 

AMSL Diabetes, manufacturer of Dexcom CGM Systems, have issued an urgent product defect warning alerting health professionals and patients that the chemotherapy drug hydroxyurea falsely elevates glucose readings on Dexcom Systems.

The defect may result in failure to treat hypoglycaemia from missed low sensor glucose values and alerts or by causing other errors in diabetes management decisions, the company warns.

Patients taking the drug, most commonly used to treat Chronic Myelogenous Leukaemia (CML), head and neck malignancies, and sickle cell disease, should be warned that the level of inaccuracy depends on the amount of hydroxyurea in the body. Patients should use their meter to avoid falsely elevated readings and missed hypoglycaemia alerts. The warning follows reports of hydroxyurea interference with the CGM device published in Diabetes Care.

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Insulin-treated diabetes linked to higher risk after PCI

Insulin-treated diabetes (ITDM) is an independent predictor of 12-month major adverse cardiovascular and cerebrovascular events (MACCE) following percutaneous coronary intervention (PCI), according to new research from Melbourne.

Findings from studies investigating whether or not diabetes treatment status affects PCI outcomes have been conflicting say investigators from Royal Melbourne Hospital’s Department of Cardiology, who conducted the retrospective analysis.

They compared clinical outcomes in patients with diabetes based on their diabetes treatment status who had undergone the procedure between 2005 and 2014 and were enrolled in the Melbourne Interventional Group registry.

Of more than 4,500 people with diabetes just over 1,100 had ITDM and 3,648 had non-ITDM.

Those treated with insulin had significantly worse 12-month MACCE and long-term mortality compared with patients not requiring insulin – an observation that persisted, albeit modestly, even after adjustment for baseline cardiovascular risk factors.

Researchers further divided the non-ITDM group by treatment – diet control only  or those taking oral hypoglycaemic agents – and found a progressively higher rate of 12-month MACCE across the 3 groups (13.5% vs. 17.9% vs. 21.8%; p<0.001), revealing a ‘gradient of risk’  for MACCE and long-term mortality with escalation of therapy for diabetes.

Investigators suggest one possible explanation for the independent association between ITDM and 12-month MACCE is that insulin may have direct effects that promote worsening of coronary artery disease

Pointing to several previous studies they say insulin is thought to ‘increase atherogenesis and therefore cardiovascular risk by promoting pro-inflammatory macrophage response and enhancing fibrinogen production’.

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New national obesity management guidelines needed 

The RACP is spearheading a push calling for new living Clinical Practice Guidelines for the management of overweight and obesity.

The College says it’s concerned that there appears to be no plans to commission new guidelines to replace the most recent offical document, published in 2013, which were rescinded  in 2018 following its standard expiry at five years.

Since then the evidence around obesity management and health improvement approaches, including technological advances, has progressed considerably and have implications for new guidelines, the RACP argues

Highlighting work already done in Canada on the release of its 2020 Adult Obesity Clinical Practice Guidelines, which has been celebrated for its ‘person-centred and accessible’ approach the RACP says new Australian guidelines could build on international experience.

With COVID-19 amplifying the impacts of obesity and people with obesity at greater risk of more serve illness from COVID, the RACP argues that now is a particularly important time to make a national investment in evidence based clinical guidelines for obesity management.

The College, along with support from 14 other organisations including the RACGP, APS, and ADS, have released a full statement here.

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