Can self-rated health scores be used for risk prediction in patients with type 2 diabetes?

OBJECTIVE: To investigate whether self-rated health profiles compiled using the EuroQol group's visual analog scale (EQ VAS) are independent predictors of vascular events and major complications in people with type 2 diabetes after controlling for standard clinical risk factors. RESEARCH DESIGN AND METHODS: The study is based on 7,348 individuals with a mean follow-up of 2.4 years after completing the EQ-5D questionnaire. We used Cox proportional hazards modeling to estimate hazard ratios associated with EQ VAS scores after controlling for baseline covariates: age, sex, smoking status, diabetes duration, A1C, systolic blood pressure, BMI, plasma lipids, and prior clinical history. RESULTS: A 10-point higher EQ VAS score was associated with a 6% (95% CI 1-11) lower risk of vascular events and a 22% (95% CI 15-28) lower risk of diabetes complications. CONCLUSIONS: Self-rated health profiles compiled using the EQ VAS provide valuable information on patient risk in addition to that determined from clinical risk factors alone

Using the EQ-5D index score as a predictor of outcomes in patients with type 2 diabetes.

OBJECTIVE: To examine whether index scores based on the EQ-5D, a 5-item generic health status measure, are an independent predictor of vascular events, other major complications and mortality in people with type 2 diabetes and to quantify the relationship between these scores and future survival. SUBJECTS: Five-year cohort study involving 7348 patients with type 2 diabetes, aged between 50-75 years who had been recruited to the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) study from Australia and New Zealand. MEASURES: Multivariate Cox proportional hazard regression models were used to estimate the hazard ratio associated with index scores derived from the EQ-5D on: (1) cardiovascular events (including coronary heart disease event, stroke, hospitalization for angina, or cardiovascular death); (2) other major diabetes-related complications (heart failure, amputation, renal dialysis, and lower extremity ulcer); and (3) death from any cause. Life table methods were used to derive expected survival for patients with different index scores. RESULTS: After adjusting for standard risk factors, a 0.1 higher index score (derived from the UK algorithm) was associated with an additional 7% (95% CI: 4-11%) lower risk of vascular events, a 13% (95% CI: 9-17%) lower risk of complications, and up to 14% (95% CI: 8-19%) lower rate of all-cause mortality. CONCLUSIONS: Index scores derived from the EQ-5D are an independent predictor of the risk of mortality, future vascular events, and other complications in people with type 2 diabetes. This should be taken into account when extrapolating health outcomes such as quality-adjusted life years (QALYs)

Baseline circulating FGF21 concentrations and increase after fenofibrate treatment predict more rapid glycemic progression in type 2 diabetes: Results from the FIELD study

BACKGROUND: It is not known whether circulating fibroblast growth factor 21 (FGF21) concentrations are associated with glycemic progression in patients with established type 2 diabetes. This study reports this relationship in type 2 diabetes patients participating in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. METHODS: Plasma FGF21 was quantified in 9697 study participants. Among patients with lifestyle-only glucose control measures at baseline, glycemic progression was defined as the initiation of oral hypoglycemic agents or insulin therapy. We assessed the relationship of FGF21 concentrations with glycohemoglobin (Hb A1c), the homeostasis model assessment of ß-cell function (HOMA-B) and insulin resistance (HOMA-IR), and glycemic progression. RESULTS: Among 2584 patients with lifestyle-only glycemic therapy at baseline, plasma FGF21 concentrations were positively associated with HOMA-IR (5.1% increase per 100% increase in FGF21 concentrations). Patients with higher baseline plasma FGF21 concentrations had higher risk of glycemic progression over a 5-year period (P=0.02), but the association was not significant after further adjusting for alanine aminotransferase (ALT) enzyme activity. During the fenofibrate active run-in phase, higher tertiles of fenofibrate-induced increase in FGF21 concentrations were associated with higher risk of glycemic progression (adjusted hazards ratio =1.09 and 1.18 for tertiles 2 and 3, respectively, P for trend = 0.01), even after adjusting for ALT enzyme activity. This association was statistically significant in the fenofibrate group only (P = 0.01). CONCLUSIONS: Higher baseline and fenofibrate-induced increase in FGF21 concentrations predict more rapid glycemic progression in type 2 diabetes patients. This association may be partly explained by hepatic function

Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol

INTRODUCTION: Manual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective of the present study is to determine the effectiveness of 6 months' closed-loop compared with manually determined insulin dosing on time-in-target glucose range in adults with type 1 diabetes. METHODS AND ANALYSIS: This open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. Participants will then be randomised 1:1 either to 26 weeks of MiniMed 670G hybrid closed-loop system therapy (Medtronic, Northridge, CA, USA) or continuation of their current diabetes therapy. The hybrid closed-loop system delivers insulin automatically to address basal requirements and correct to target glucose level, while bolus doses for meals require user initiation and carbohydrate estimation. Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9-10.0 mmol/L) during the final 3 weeks of intervention. Secondary outcomes include: other CGM parameters, HbA1c, severe hypoglycaemia, psychosocial well-being, sleep, cognition, electrocardiography, costs, quality of life, biomarkers of vascular health and hybrid closed-loop system performance. Semistructured interviews will assess the expectations and experiences of a subgroup of hybrid closed-loop users. ETHICS AND DISSEMINATION: The study has Human Research Ethics Committee approval. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated at scientific conferences and via peer-reviewed publications. TRIAL REGISTRATION NUMBER: ACTRN12617000520336; Pre-results