Artificial intelligence for automated detection of diabetic foot ulcers: A real-world proof-of-concept clinical evaluation.

OBJECTIVE: Conduct a multicenter proof-of-concept clinical evaluation to assess the accuracy of an artificial intelligence system on a smartphone for automated detection of diabetic foot ulcers. METHODS: The evaluation was undertaken with patients with diabetes (n = 81) from September 2020 to January 2021. A total of 203 foot photographs were collected using a smartphone, analysed using the artificial intelligence system, and compared against expert clinician judgement, with 162 images showing at least one ulcer, and 41 showing no ulcer. Sensitivity and specificity of the system against clinician decisions was determined and inter- and intra-rater reliability analysed. RESULTS: Predictions/decisions made by the system showed excellent sensitivity (0.9157) and high specificity (0.8857). Merging of intersecting predictions improved specificity to 0.9243. High levels of inter- and intra-rater reliability for clinician agreement on the ability of the artificial intelligence system to detect diabetic foot ulcers was also demonstrated (Kα > 0.8000 for all studies, between and within raters). CONCLUSIONS: We demonstrate highly accurate automated diabetic foot ulcer detection using an artificial intelligence system with a low-end smartphone. This is the first key stage in the creation of a fully automated diabetic foot ulcer detection and monitoring system, with these findings underpinning medical device development.

Efficacy and Cardiovascular Safety of Thiazolidinediones.

Type 2 diabetes mellitus (T2DM) is characterized by a progressive beta cell dysfunction in the setting of peripheral insulin resistance. Insulin resistance in subjects with type 2 diabetes and metabolic syndrome is primarily caused by an ectopic fat accumulation in the liver and skeletal muscle. Insulin sensitizers are particularly important in the management of T2DM. Though thiazolidinediones (TZDs) are principally insulin sensitizers, they possess an ability to preserve pancreatic ß-cell function and thereby exhibit durable glycemic control. Cardiovascular outcome trials (CVOTs) have shown that Glucagon-like-peptide 1 receptor agonists (GLP-1 RAs) and sodium glucose transporter-2 inhibitors (SGLT2i) have proven cardiovascular safety. In this era of CVOTs, drugs with proven cardiovascular (CV) safety are often preferred in patients with preexisting cardiovascular disease or at risk of cardiovascular disease. In this review, we will describe the three available drugs belonging to the TZD family, with special emphasis on their efficacy and CV safety.

Efficacy and Cardiovascular Safety of DPP-4 Inhibitors.

Dipeptidyl peptidase-4 (DPP-4) inhibitors or gliptins belong to the class of incretin mimetics. These drugs have been available on the market for the management of type 2 diabetes mellitus (T2DM) for over a decade. Sitagliptin, linagliptin, vildagliptin, saxagliptin and alogliptin are widely available globally, whilst anagliptin, gemigliptin and teneliptin are used mainly in the Asian countries. The glycemic control conferred by DPP-4 inhibitors varies among individual molecules with an average reduction of glycated hemoglobin (HbA1c) ranging between -0.5 to -1.0% with monotherapy. Additive effects on HbA1c reduction may result from combination therapy with other antidiabetics. Weak evidence from various studies suggests that DPP-4 inhibitors may be useful in treating nonalcoholic fatty liver disease (NAFLD) and polycystic ovary syndrome (PCOS). DPP-4 inhibitors safety is not established in pregnancy, and there is only meagre evidence of its use in T2DM among children. In line with the United States Food and Drug Administration (US FDA) recommendations, sitagliptin, linagliptin, saxagliptin and alogliptin have undergone rigorous cardiovascular outcome trials (CVOTs) in recent years, and the safety data for vildagliptin is available through retrospective analysis of various studies in meta-analysis. Small clinical trial, and meta-analysis based data are available for the CV safety of other DPP-4 inhibitors. In general, the CVOTs and other safety data do not reveal serious warning signals except for saxagliptin (higher risk of hospitalization from heart failure [hHF]), although there is no robust data on the risk of hHF among patients with moderate to severe HF at baseline treated with other DPP-4 inhibitors. This review critically appraises the efficacy and cardiovascular safety of DPP-4 inhibitors to empower clinicians to use this class of antidiabetic medications judiciously.

A Review of the Efficacy and Cardiovascular Safety of Amylin Analogues.

A large proportion of persons with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) do not reach the glycosylated haemoglobin (HbA1c) target of < 7% (53 mmol/- mol), with an increasing proportion of them being overweight or obese. In both T1DM and T2DM, there is accelerated gastric emptying and postprandial hyperglucagonemia. Furthermore, insulin therapy itself is associated with risk of hypoglycemia and weight-gain both of which are barriers to achieving good control. Medications which can achieve significant HbA1c and weight reduction associated with an ability to delay gastric emptying and suppress the glucagon secretion with minimal/ no hypoglycemia are of particular interest as an adjuvant to insulin. A synthetic amylin analogue, pramlintide is a drug with above mentioned properties. Other medications with similar properties are glucagon-like peptide-1 receptor agonists (GLP-1 RAs). In this article, we will review the efficacy of pramlintide when given with insulin in improving HbA1c, weight, and cognition with- /without GLP-1 RAs as well as its cardiovascular (CV) safety.

Activation of coagulation occurs after electrical cardioversion in patients with chronic atrial fibrillation despite optimal anticoagulation with warfarin.

BACKGROUND: There is evidence for the activation of the coagulation system and a hypercoagulable state following cardioversion. The aim of the study was to determine whether electrical cardioversion in patients with chronic atrial fibrillation induced a prothrombotic state despite optimal anticoagulation. We studied the effects of electrical cardioversion on plasma levels of fibrinogen, antithrombin III, protein C and D-dimers. METHODS: We studied 24 patients with chronic atrial fibrillation who were on optimal anticoagulation and were referred for electrical cardioversion. Samples of venous blood were taken 2 h pre and post cardioversion and 1 month later. RESULTS: Plasma median concentrations of fibrinogen decreased significantly from 3.8 g/l (interquartile range 3.1-4.2 g/l) before cardioversion to 3.5 g/l (interquartile range 2.9-3.9 g/l) 2 h after cardioversion levels (P=0.004). The fibrinogen levels at 1 month post cardioversion (3.45 g/l, interquartile range 3.1-3.9 g/l) were also significantly lower than baseline (P=0.02). Plasma median levels of antithrombin III fell from 93.5 U/dl (interquartile range 89.3-97.0 U/dl) pre cardioversion to 89.5 U/dl (interquartile range 83.0-93.0 U/dl) 2 h after cardioversion (P=0.001) and returned to normal by 1 month (94.0 U/dl; interquartile range 89.3-98.5 U/dl; P=0.0001). There were no significant changes in plasma median D-dimer or protein C levels at any time. CONCLUSIONS: We have demonstrated a significant fall in the plasma fibrinogen and antithrombin III levels in patients with chronic atrial fibrillation early after electrical cardioversion, indicating thrombin generation. This study suggests that there are haemostatic changes of thrombogenesis induced by cardioversion despite optimal anticoagulation with warfarin.