Cost effectiveness of dietitian-led nutrition therapy for people with type 2 diabetes mellitus: a scoping review.

BACKGROUND: The management of diabetes costs in excess of $1.3 trillion per annum worldwide. Diet is central to the management of type 2 diabetes. It is not known whether dietetic intervention is cost effective. This scoping review aimed to map the existing literature concerning the cost effectiveness of medical nutrition therapy provided by dietitians for people with type 2 diabetes. METHODS: Thirteen scientific databases, including MEDLINE, EMBASE and CINAHL, as well as multiple official websites, were searched to source peer-reviewed articles, reports, guidelines, dissertations and other grey literature published from 2008 to present. Eligible articles had to have assessed and reported the cost effectiveness of dietetic intervention for adults with type 2 diabetes in developed countries. Experimental, quasi-experimental, observational and qualitative studies were considered. RESULTS: Of 2387 abstracts assessed for eligibility, four studies combining 22 765 adults with type 2 diabetes were included. Dietetic intervention was shown to be cost-effective in terms of diabetes-related healthcare costs and hospital charges, at the same time as also reducing the risk of cumulative days at work lost to less than half and the risk of disability 'sick' days at work to less than one-seventh. CONCLUSIONS: The findings highlight the importance of advocacy for medical nutrition therapy for people with type 2 diabetes, with respect to alleviating the great global economic burden from this condition. Further studies are warranted to elucidate the factors that mediate and moderate cost effectiveness and to allow for the generalisation of the findings.

Successful implementation of diabetes audits in Australia: the Australian National Diabetes Information Audit and Benchmarking (ANDIAB) initiative.

AIM: We developed and implemented a national audit and benchmarking programme to describe the clinical status of people with diabetes attending specialist diabetes services in Australia. METHODS: The Australian National Diabetes Information Audit and Benchmarking (ANDIAB) initiative was established as a quality audit activity. De-identified data on demographic, clinical, biochemical and outcome items were collected from specialist diabetes services across Australia to provide cross-sectional data on people with diabetes attending specialist centres at least biennially during the years 1998 to 2011. RESULTS: In total, 38 155 sets of data were collected over the eight ANDIAB audits. Each ANDIAB audit achieved its primary objective to collect, collate, analyse, audit and report clinical diabetes data in Australia. Each audit resulted in the production of a pooled data report, as well as individual site reports allowing comparison and benchmarking against other participating sites. CONCLUSIONS: The ANDIAB initiative resulted in the largest cross-sectional national de-identified dataset describing the clinical status of people with diabetes attending specialist diabetes services in Australia. ANDIAB showed that people treated by specialist services had a high burden of diabetes complications. This quality audit activity provided a framework to guide planning of healthcare services.

Improvement in glycated haemoglobin evaluated by baseline body mass index: a meta-analysis of the liraglutide phase III clinical trial programme.

In the liraglutide clinical trial programme, liraglutide 1.2 and 1.8 mg were found to effectively lower glycated haemoglobin (HbA1c) in patients with type 2 diabetes (T2D). It is unknown whether baseline body mass index (BMI) is a predictor of change in HbA1c observed during a clinical trial with liraglutide or placebo treatment. The present meta-analysis of patient-level data, using pooled data from seven phase III trials [LEAD-1-6 and the liraglutide versus sitagliptin trial (LIRA-DPP-4)] for liraglutide 1.2, 1.8 mg and placebo (n = 3222), identified no significant correlation between baseline BMI (<20 kg/m(2) up to 45 kg/m(2) ) and HbA1c reduction for placebo or liraglutide 1.2 mg, and a modest, clinically non-relevant, association for liraglutide 1.8 mg [-0.010 (95% confidence interval -0.020, -0.001)], whereby a 10 kg/m(2) increase in baseline BMI corresponded to 0.10%-point (1.1 mmol/mol) greater HbA1c reduction. In summary, reductions in HbA1c obtained during clinical trials with liraglutide or placebo treatment were independent of baseline BMI.

Cost to government and society of chronic kidney disease stage 1-5: a national cohort study.

BACKGROUND: Costs associated with chronic kidney disease (CKD) are not well documented. Understanding such costs is important to inform economic evaluations of prevention strategies and treatment options. AIM: To estimate the costs associated with CKD in Australia. METHODS: We used data from the 2004/2005 AusDiab study, a national longitudinal population-based study of non-institutionalised Australian adults aged ≥25 years. We included 6138 participants with CKD, diabetes and healthcare cost data. The annual age and sex-adjusted costs per person were estimated using a generalised linear model. Costs were inflated from 2005 to 2012 Australian dollars using best practice methods. RESULTS: Among 6138 study participants, there was a significant difference in the per-person annual direct healthcare costs by CKD status, increasing from $1829 (95% confidence interval (CI): $1740-1943) for those without CKD to $14 545 (95% CI: $5680-44 842) for those with stage 4 or 5 CKD (P < 0.01). Similarly, there was a significant difference in the per-person annual direct non-healthcare costs by CKD status from $524 (95% CI: $413-641) for those without CKD to $2349 (95% CI: $386-5156) for those with stage 4 or 5 CKD (P < 0.01). Diabetes is a common cause of CKD and is associated with increased health costs. Costs per person were higher for those with diabetes than those without diabetes in all CKD groups; however, this was significant only for those without CKD and those with early stage (stage 1 or 2) CKD. CONCLUSION: Individuals with CKD incur 85% higher healthcare costs and 50% higher government subsidies than individuals without CKD, and costs increase by CKD stage. Primary and secondary prevention strategies may reduce costs and warrant further consideration.

Estimating insulin demand for protein-containing foods using the food insulin index.

BACKGROUND/OBJECTIVE: The Food Insulin Index (FII) is a novel algorithm for ranking foods on the basis of insulin responses in healthy subjects relative to an isoenergetic reference food. Our aim was to compare postprandial glycemic responses in adults with type 1 diabetes who used both carbohydrate counting and the FII algorithm to estimate the insulin dosage for a variety of protein-containing foods. SUBJECTS/METHODS: A total of 11 adults on insulin pump therapy consumed six individual foods (steak, battered fish, poached eggs, low-fat yoghurt, baked beans and peanuts) on two occasions in random order, with the insulin dose determined once by the FII algorithm and once with carbohydrate counting. Postprandial glycemia was measured in capillary blood glucose samples at 15-30 min intervals over 3 h. Researchers and participants were blinded to treatment. RESULTS: Compared with carbohydrate counting, the FII algorithm significantly reduced the mean blood glucose level (5.7±0.2 vs 6.5±0.2 mmol/l, P=0.003) and the mean change in blood glucose level (-0.7±0.2 vs 0.1±0.2 mmol/l, P=0.001). Peak blood glucose was reached earlier using the FII algorithm than using carbohydrate counting (34±5 vs 56±7 min, P=0.007). The risk of hypoglycemia was similar in both treatments (48% vs 33% for FII vs carbohydrate counting, respectively, P=0.155). CONCLUSIONS: In adults with type 1 diabetes, compared with carbohydrate counting, the novel FII algorithm improved postprandial hyperglycemia after consumption of protein-containing foods.

Intensification of medication and glycaemic control among patients with type 2 diabetes - the ADVANCE trial.

AIMS: The aim of this study was to assess associations between patient characteristics, intensification of blood glucose-lowering treatment through oral glucose-lowering therapy and/or insulin and effective glycaemic control in type 2 diabetes. METHODS: 11 140 patients from the Action in Diabetes and Vascular disease: preterAx and diamicroN-MR Controlled Evaluation (ADVANCE) trial who were randomized to intensive glucose control or standard glucose control and followed up for a median of 5 years were categorized into two groups: effective glycaemic control [haemoglobin A1c (HbA1c) ≤ 7.0% or a proportionate reduction in HbA1c over 10%] or ineffective glycaemic control (HbA1c > 7.0% and a proportionate reduction in HbA1c less than or equal to 10%). Therapeutic intensification was defined as addition of an oral glucose-lowering agent or commencement of insulin. Pooled logistic regression models examined the associations between patient factors, intensification and effective glycaemic control. RESULTS: A total of 7768 patients (69.7%), including 3198 in the standard treatment group achieved effective glycaemic control. Compared to patients with ineffective control, patients with effective glycaemic control had shorter duration of diabetes and lower HbA1c at baseline and at the time of treatment intensification. Treatment intensification with addition of an oral agent or commencement of insulin was associated with a 107% [odds ratio, OR: 2.07 (95% confidence interval, CI: 1.95-2.20)] and 152% [OR: 2.52 (95% CI: 2.30-2.77)] greater chance of achieving effective glycaemic control, respectively. These associations were robust after adjustment for several baseline characteristics and not modified by the number of oral medications taken at the time of treatment intensification. CONCLUSIONS: Effective glycaemic control was associated with treatment intensification at lower HbA1c levels at all stages of the disease course and in both arms of the ADVANCE trial.

Cost effectiveness of primary care referral to a commercial provider for weight loss treatment, relative to standard care: a modelled lifetime analysis.

BACKGROUND: Because of the high prevalence of overweight and obesity, there is a need to identify cost-effective approaches for weight loss in primary care and community settings. OBJECTIVE: To evaluate the long-term cost effectiveness of a commercial weight loss programme (Weight Watchers) (CP) compared with standard care (SC), as defined by national guidelines. METHODS: A Markov model was developed to calculate the incremental cost-effectiveness ratio (ICER), expressed as the cost per quality-adjusted life year (QALY) over the lifetime. The probabilities and quality-of-life utilities of outcomes were extrapolated from trial data using estimates from the published literature. A health sector perspective was adopted. RESULTS: Over a patient's lifetime, the CP resulted in an incremental cost saving of AUD 70 per patient, and an incremental 0.03 QALYs gained per patient. As such, the CP was found to be the dominant treatment, being more effective and less costly than SC (95% confidence interval: dominant to 6225 per QALY). Despite the CP delaying the onset of diabetes by ∼10 months, there was no significant difference in the incidence of type 2 diabetes, with the CP achieving <0.1% fewer cases than SC over the lifetime. CONCLUSION: The modelled results suggest that referral to community-based interventions may provide a highly cost-effective approach for those at high risk of weight-related comorbidities.

Trends in overweight and obesity over 22 years in a large adult population: the HUNT Study, Norway.

Some reports indicate that the obesity epidemic may be slowing down or halting. We followed body mass index (BMI) and waist circumference (WC) in a large adult population in Norway (n = 90 000) from 1984-1986 (HUNT1) through 1995-1997 (HUNT2) to 2006-2008 (HUNT3) to study whether this is occurring in Norway. Height and weight were measured with standardized and identical methods in all three surveys; WC was also measured in HUNT2 and HUNT3. In the three surveys, mean BMI increased from 25.3 to 26.5 and 27.5 kg m-2 in men and from 25.1 to 26.2 and 26.9 kg m-2 in women. Increase in prevalence of obesity (BMI ≥ 30 kg m-2) was greater in men (from 7.7 to 14.4 and 22.1%) compared with women (from 13.3 to 18.3 and 23.1%). In contrast, women had a greater increase in abdominal obesity (WC ≥ 102 cm for men and WC ≥ 88 cm for women). There was a continuous shift in the distribution curve of BMI and WC to the right, demonstrating that the increase in body weight was occurring in all weight groups, but the increase of obesity was greatest in the youngest age groups. Our data showed no signs of a halt in the increase of obesity in this representative Norwegian population.

A within-trial cost-effectiveness analysis of primary care referral to a commercial provider for weight loss treatment, relative to standard care--an international randomised controlled trial.

BACKGROUND: Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community settings. OBJECTIVE: We evaluated the cost effectiveness of two weight loss programmes of 1-year duration, either standard care (SC) as defined by national guidelines, or a commercial provider (Weight Watchers) (CP). DESIGN: This analysis was based on a randomised controlled trial of 772 adults (87% female; age 47.4±12.9 years; body mass index 31.4±2.6 kg m(-2)) recruited by health professionals in primary care in Australia, United Kingdom and Germany. Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER, expressed as the cost per quality adjusted life year (QALY). RESULTS: The cost per kilogram of weight loss was USD122, 90 and 180 for the CP in Australia, the United Kingdom and Germany, respectively. For SC the cost was USD138, 151 and 133, respectively. From a health-sector perspective, the ICER for the CP relative to SC was USD18 266, 12 100 and 40 933 for Australia, the United Kingdom and Germany, respectively. Corresponding societal ICER figures were USD31,663, 24,996 and 51,571. CONCLUSION: The CP was a cost-effective approach from a health funder and societal perspective. Despite participants in the CP group attending two to three times more meetings than the SC group, the CP was still cost effective even including these added patient travel costs. This study indicates that it is cost effective for general practitioners (GPs) to refer overweight and obese patients to a CP, which may be better value than expending public funds on GP visits to manage this problem.

Oral disease in relation to future risk of dementia and cognitive decline: prospective cohort study based on the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) trial.

OBJECTIVE: Examine the association of oral disease with future dementia/cognitive decline in a cohort of people with type 2 diabetes. METHODS: A total of 11,140 men and women aged 55-88 years at study induction with type 2 diabetes participated in a baseline medical examination when they reported the number of natural teeth and days of bleeding gums. Dementia and cognitive decline were ascertained periodically during a 5-year follow-up. RESULTS: Relative to the group with the greatest number of teeth (more than or equal to 22), having no teeth was associated with the highest risk of both dementia (hazard ratio; 95% confidence interval: 1.48; 1.24, 1.78) and cognitive decline (1.39; 1.21, 1.59). Number of days of bleeding gums was unrelated to these outcomes. CONCLUSIONS: Tooth loss was associated with an increased risk of both dementia and cognitive decline.

Optimal management of type 2 diabetes: the evidence.

This paper reviews the evidence in relation to the optimal target for HbA1c and outlines a global treatment algorithm for people with type 2 diabetes. While most guidelines recommend a general HbA1c target of 7%, recent large scale intervention studies have examined the potential benefits of lower targets. These studies have generally shown that lower HbA1c targets provide no macrovascular benefits and limited effects on microvascular complications while increasing rates of hypoglycaemia. Overall these studies do not support a general HbA1c target lower than 7.0%. However an individual's HbA1c target should be set and reviewed taking into account treatment benefits, safety, and tolerability. This may mean that an HbA1c target lower than 7% is appropriate for some when it can be easily and safely achieved but equally a higher HbA1c target may be appropriate in others. Clinicians and consumers are fortunate in having a wide range of pharmacological agents available to treat hyperglycaemia, however access to many of these options is limited in many middle and low income countries. Developing treatment algorithms is complex for several reasons. The major limitation is the limited evidence base for choosing particular treatment options or combinations of medications. However it is possible to derive a generic evidence-informed consensus algorithm which considers availability, access and cost of medications which can be adapted for local country use.

The management of Type 2 diabetes: a survey of Australian general practitioners.

OBJECTIVE: To explore how clinical and demographic variables impact on the management of diabetes mellitus in general practice. DESIGN: A structured vignette survey was conducted in Australia. This included nine vignettes chosen at random from 128 developed around seven clinical variables. Respondents were asked to recommend a change in treatment and make specific recommendations. A random sample of general practitioners (GPs) were recruited. Two diabetologists involved in the development of national guidelines also participated. RESULTS: 125 (13.8%) GPs participated. Statistical analyses were used to generate outcome measures. GPs recommended a change in treatment for most (81.1%) cases; were less likely to prescribe a statin (68.5% GPs vs. 76.3% diabetologists), less likely to treat hypertension (66.7% vs.89%) and less likely to refer for lifestyle modification (82.3% vs. 96.5%). Significant disagreement occurred around prescribing or changing oral hypoglycaemics. No GP characteristics showed significant impact. The proportion of GPs who agreed with diabetiologists on dose and choice of drugs was 35.7% for statins, 49.6% for antihypertensives and 39.6% for oral hypoglycaemics. CONCLUSIONS: There were significant differences between diabetologists and GPs on the management of diabetes. The survey suggests significant under-dosing by GPs. These findings warrant further investigation.

Association of HbA1c levels with vascular complications and death in patients with type 2 diabetes: evidence of glycaemic thresholds.

AIMS/HYPOTHESIS: There is conflicting evidence regarding appropriate glycaemic targets for patients with type 2 diabetes. Here, we investigate the relationship between HbA(1c) and the risks of vascular complications and death in such patients. METHODS: Eleven thousand one hundred and forty patients were randomised to intensive or standard glucose control in the Action in Diabetes and Vascular disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Glycaemic exposure was assessed as the mean of HbA(1c) measurements during follow-up and prior to the first event. Adjusted risks for each HbA(1c) decile were estimated using Cox models. Possible differences in the association between HbA(1c) and risks at different levels of HbA(1c) were explored using linear spline models. RESULTS: There was a non-linear relationship between mean HbA(1c) during follow-up and the risks of macrovascular events, microvascular events and death. Within the range of HbA(1c) studied (5.5-10.5%), there was evidence of 'thresholds', such that below HbA(1c) levels of 7.0% for macrovascular events and death, and 6.5% for microvascular events, there was no significant change in risks (all p > 0.8). Above these thresholds, the risks increased significantly: every 1% higher HbA(1c) level was associated with a 38% higher risk of a macrovascular event, a 40% higher risk of a microvascular event and a 38% higher risk of death (all p < 0.0001). CONCLUSIONS/INTERPRETATION: In patients with type 2 diabetes, HbA(1c) levels were associated with lower risks of macrovascular events and death down to a threshold of 7.0% and microvascular events down to a threshold of 6.5%. There was no evidence of lower risks below these levels but neither was there clear evidence of harm.

The burden of cardiovascular disease associated with high body mass index in the Asia-Pacific region.

Studying obesity in the Asia-Pacific region is difficult because of the diverse ethnic background and different stages of economic and nutrition transition. The burden of cardiovascular disease associated with overweight (defined as body mass index ≥25 kg m(-2) ) was previously estimated for countries within the region. However, using the conventional cut-point of 25 kg m(-2) ignores the continuous association between body mass index and cardiovascular disease from approximately 20 kg m(-2) . By estimating the proportion of cardiovascular disease that would be prevented if the theoretical mean body mass index in the population was shifted to 21 kg m(-2) , nationally representative data from 15 countries suggested the population attributable fractions for cardiovascular disease were approximately three times higher than the previous estimates. Coronary heart disease attributable to body mass index other than 21 kg m(-2) ranged from 2% in India to 58% in American Samoa. Similarly, the population attributable fraction for ischaemic stroke ranged from 3% in India to 64% in American Samoa. If cardiovascular risk increases from 21 kg m(-2) applies to all populations, most countries in the region will need to aim towards substantially reducing their current population mean body mass index in order to lower the burden of cardiovascular disease associated with excess weight.

The Evaluation of Screening and Early Detection Strategies for Type 2 Diabetes and Impaired Glucose Tolerance (DETECT-2) update of the Finnish diabetes risk score for prediction of incident type 2 diabetes.

AIMS/HYPOTHESIS: The Finnish diabetes risk questionnaire is a widely used, simple tool for identification of those at risk for drug-treated type 2 diabetes. We updated the risk questionnaire by using clinically diagnosed and screen-detected type 2 diabetes instead of drug-treated diabetes as an endpoint and by considering additional predictors. METHODS: Data from 18,301 participants in studies of the Evaluation of Screening and Early Detection Strategies for Type 2 Diabetes and Impaired Glucose Tolerance (DETECT-2) project with baseline and follow-up information on oral glucose tolerance status were included. Incidence of type 2 diabetes within 5 years was used as the outcome variable. Improvement in discrimination and classification of the logistic regression model was assessed by the area under the receiver-operating characteristic (ROC) curve and by the net reclassification improvement. Internal validation was by bootstrapping techniques. RESULTS: Of the 18,301 participants, 844 developed type 2 diabetes in a period of 5 years (4.6%). The Finnish risk score had an area under the ROC curve of 0.742 (95% CI 0.726-0.758). Re-estimation of the regression coefficients improved the area under the ROC curve to 0.766 (95% CI 0.750-0.783). Additional items such as male sex, smoking and family history of diabetes (parent, sibling or both) improved the area under the ROC curve and net reclassification. Bootstrapping showed good internal validity. CONCLUSIONS/INTERPRETATION: The predictive value of the original Finnish risk questionnaire could be improved by adding information on sex, smoking and family history of diabetes. The DETECT-2 update of the Finnish diabetes risk questionnaire is an adequate and robust predictor for future screen-detected and clinically diagnosed type 2 diabetes in Europid populations.

Diabesity: therapeutic options.

A pathogenic relationship exists between type 2 diabetes and obesity. Over the last decade, the escalation in diabetes cases has paralleled the rapid increase in obesity rates, constituting a global health crisis. Environmental risk factors attributed to the global increase in obesity include the consumption of high-calorie, high-fat foods and inadequate physical activity. Obese individuals may also have a genetic predisposition for obesity. Both diabetes and obesity confer an elevated risk of developing a range of complications and comorbidities, including cardiovascular disease, hypertension and stroke, which can complicate disease management. This review examines the aetiology of the linkages between diabetes and obesity and the range of available therapies. Recent clinical evidence substantiating the efficacy and safety of incretin-based antidiabetic therapies is analysed, in addition to data on antiobesity therapeutic strategies, such as antiobesity agents, behaviour modification and bariatric surgery. Glucose control is often accompanied by weight-neutral or modest weight reduction effects with DPP-4 inhibitor treatment (sitagliptin, vildagliptin, saxagliptin) and weight loss with GLP-1 receptor agonist therapy (exenatide, liraglutide). Studies of antiobesity agents including orlistat, sibutramine and rimonabant have shown attrition rates of 30-40%, and the long-term effects of these agents remain unknown. Bariatric surgical procedures commonly performed are laparoscopic adjustable banding of the stomach and the Roux-en-Y gastric bypass, and have produced type 2 diabetes remission rates of up to 73%. Therapeutic strategies that integrate glycaemic control and weight loss will assume greater importance as the prevalence of diabetes and obesity increase.