Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis.

AIMS: We compared the effects of continuous subcutaneous insulin infusion (CSII) with those of multiple daily insulin (MDI) injections on glycaemic control, risk of hypoglycaemic episodes, insulin requirements and adverse events in type 1 and type 2 diabetes mellitus. METHODS: The electronic databases MEDLINE, EMBASE and CENTRAL were systematically searched for randomised controlled trials up to March 2007. A systematic review and meta-analysis were performed. RESULTS: Overall, 22 studies were included (17 on type 1 diabetes mellitus, two on type 2 diabetes mellitus, three on children). With regard to adults with type 1 diabetes mellitus, our meta-analysis found a between-treatment difference of -0.4% HbA(1c) (six studies) in favour of CSII therapy. Available median rates of mild or overall hypoglycaemic events were comparable between the different interventions (1.9 [0.9-3.1] [CSII] vs 1.7 [1.1-3.3] [MDI] events per patient per week). Total daily insulin requirements were lower with CSII than with MDI therapy. In patients with type 2 diabetes mellitus, CSII and MDI treatment showed no statistically significant difference for HbA(1c). The incidence of mild hypoglycaemic events was comparable between the treatment groups. In adolescents with type 1 diabetes mellitus, glycated haemoglobin and insulin requirements were significantly lower in the CSII groups; no data were available on hypoglycaemic events. The only study performed in younger children did not provide enough data for conclusive inferences. No overall conclusions were possible for severe hypoglycaemia and adverse events for any of the different patient groups due to rareness of such events, different definitions and insufficient reporting. CONCLUSIONS/INTERPRETATION: CSII therapy in adults and adolescents with type 1 diabetes mellitus resulted in a greater reduction of glycated haemoglobin, in adult patients without a higher rate of hypoglycaemia. No beneficial effect of CSII therapy could be detected for patients with type 2 diabetes mellitus.

Epidemiology of complications and total treatment costs from diagnosis of Type 2 diabetes in Germany (ROSSO 4).

OBJECTIVE: To determine the occurrence of complications and treatment costs in the first 6 years from diagnosis of Type 2 diabetes in the primary care level. DESIGN: The German multi-centre, retrospective epidemiological cohort study ROSSO observed patients from diagnosis in 1995-1999 until the end of 2003 or loss to follow-up. SETTING: 192 randomly contacted primary care practices and all patient records of newly diagnosed type 2 diabetes patients. PARTICIPANTS: All 3,142 patients insured in a public health insurance plan. MAIN OUTCOME MEASURES: Diabetes-related complications were documented from patient files. Treatment costs were attributed using the doctor's tariff, hospital DRGs and medication price lists for Germany. RESULTS: At diagnosis, already 22.4% of patients presented with CHD, 15.4% with CHF, 5.8% with pAOD, 3.1% with stroke and 3.9% with AMI, but less than 0.5% with documented microvascular complications. 7.4% of patients were diagnosed with prior depression and, 5.0% with polyneuropathy. Within a mean of 6.5 years of follow-up 114 patients (3.6%) died. The cumulated occurrence of AMI and stroke rose without a lag phase almost linearly from diagnosis reaching 6.7% for AMI and 7.7% for stroke. The total number of strokes was significantly higher than AMI (181 strokes vs. 109 AMI; p

[Evidence and medical decision-making--what kind of evidence do we really need?]. / Evidenz und Entscheidungsprozesse in der Medizin--welche Evidenz brauchen wir wirklich?

The principle of evidence-based medicine and its associated hierarchy of study designs has been the topic of numerous, and sometimes controversial, discussions. We are convinced that the current evidence hierarchy based upon study design is not suitable for all situations in medical decision-making, for example those related to the reality of care. We would like to show that, for a number of medically important questions (e.g. in policy-making), study designs other than RCTs are required, and would therefore propose that evidence levels be based on an objective evaluation of the quality of the study (free of bias, confounding or effect-modifiers) rather than of the specific design.

[Costs of diabetes mellitus type 2 and self measurement of blood glucose in Germany]. / Kosten der Blutzuckerselbstmessung bei Diabetes mellitus Typ 2 in Deutschland aus Perspektive der gesetzlichen Kassen.

UNLABELLED: It is extremely difficult to assess the prevalence and the total costs of diabetes mellitus for the German health care system. The last sound assessment of the total costs is based on the CODE-2 study, although this study reflects the situation in 1998. METHODS: In this paper we assess again the total costs of diabetes mellitus type 2 and self measurement of blood glucose (SMBG) for the German healthcare system, based on the analysis of a recently published retrospective, multicentre trial dealing with the impact of SMBG on long-term patient outcomes. RESULTS: Overall, yearly costs for the treatment of diabetes mellitus type 2 and its complications amount to Euro 3 196,-per patient. This equals 4.6% to 8.2% of the German healthcare expenditure, in relation to the estimated prevalence of the disease in Germany. The cost difference between the cohorts with and without SMBG was not essential (Euro 290,-higher costs in the cohort with SMBG). CONCLUSIONS: From a public health standpoint, prevention of diabetes mellitus or at least prevention of its complications by optimising glucose metabolism should be given highest priority in times of limited resources for healthcare. SMBG is perhaps a valuable tool to achieve this target.

The long-term cost-effectiveness of improving alcohol abstinence with adjuvant acamprosate.

A computer model was developed with decision analysis software to explore the long-term clinical and economic outcomes of alcohol abstinence maintenance with either standard counselling therapy or standard therapy plus 48 weeks of adjuvant acamprosate in detoxified alcoholic patients. Important complications of alcoholism were modelled using Markov processes, and included relapse (return to drinking), alcohol-related hepatic disease, acute and chronic pancreatitis, acute and chronic gastritis, oropharyngeal carcinoma, oesophageal carcinoma, alcoholic cardiomyopathy, alcohol-related peripheral neuropathy, alcoholic psychosis, accidental death, and suicide. Probabilities of developing complications were dependent on whether the patients within the cohort remained abstinent or had relapsed. Relapse rates, probabilities, and costs for acamprosate therapy and treatment of complications were taken from published literature. The analysis was performed from the German health insurance perspective. Life expectancy and total lifetime costs (costs of initial abstinence maintenance therapy plus costs of complications) were calculated for a typical male cohort with average age of 41 years, 80% with fatty liver, 15% with cirrhosis, 22% with chronic pancreatitis, and 1% with alcoholic cardiomyopathy at baseline. Life expectancy with and without acamprosate therapy was 15.90 and 14.70 years respectively, and discounted (5% per annum) average total lifetime costs per patient were DEM 46 448 and DEM 49 549 respectively. We conclude that, despite the acquisition costs of DEM 2177, adjuvant acamprosate therapy was both clinically and economically attractive under conservative assumptions.

The cost-effectiveness of different management strategies for type I diabetes: a Swiss perspective.

AIMS/HYPOTHESIS: A computer model was developed to determine the health outcomes and economic consequences of different combinations of diabetes interventions in newly diagnosed patients with Type I (insulin-dependent) diabetes in Switzerland. METHODS: We modelled seven complications of diabetes: hypoglycaemia, ketoacidosis, acute myocardial infarction, stroke, lower extremity amputation, nephropathy, and retinopathy. Transition probabilities and costs were taken from published literature. The Swiss health insurance payer perspective was taken. Various combinations of diabetes management strategies, including intensive or conventional insulin therapy and screening and treatment strategies for renal and eye disease were defined. Life expectancy, cumulative incidences of complications, and mean expected total lifetime costs per patient were calculated under six different management strategies. Incremental cost-effectiveness ratios were calculated in terms of costs per life-year gained compared with conventional insulin therapy alone. RESULTS: The addition of screening for microalbuminuria and retinopathy followed by appropriate treatment, if detected, were cost saving, with reduction in cumulative incidence of end stage renal disease and blindness respectively, and, in the case of microalbulminuria screening and treatment, an improvement in life expectancy. Intensive therapy improved life expectancy but increased total lifetime costs. CONCLUSION/INTERPRETATION: Optimal management of Type I diabetic patients, including secondary and tertiary prevention, leads to reduced complications and improved life expectancy, with the increased costs of prevention offset to varying degrees by cost savings due to complications avoided.