glycemic control

Abstract: OBJECTIVES: To project the long-term clinical and economic outcomes of treatment with biphasic insulin aspart 30 (BIAsp 70/30, 30\% soluble and 70\% protaminated insulin aspart) vs. insulin glargine in insulin-naive type 2 diabetes patients failing to achieve glycemic control with oral antidiabetic agents alone (OADs). METHODS: Baseline patient characteristics and treatment effect data from the recent INITIATE clinical trial served as input to a peer-reviewed, validated Markov/Monte-Carlo simulation model. INITIATE demonstrated improvements in HbA1c favouring BIAsp 70/30 vs. glargine (-0.43\%; p < 0.005) and greater efficacy in reaching glycaemic targets among patients poorly controlled on OAD therapy. Effects on life expectancy (LE), quality-adjusted life expectancy (QALE), cumulative incidence of diabetes-related complications and direct medical costs (2004 USD) were projected over 35 years. Clinical outcomes and costs were discounted at a rate of 3.0\% per annum. Sensitivity analyses were performed. RESULTS: Improvements in glycaemic control were projected to lead to gains in LE (0.19 +/- 0.24 years) and QALE (0.19 +/- 0.17 years) favouring BIAsp 70/30 vs. glargine. Treatment with BIAsp 70/30 was also associated with reductions in the cumulative incidences of diabetes-related complications, notably in renal and retinal conditions. The incremental cost-effectiveness ratio was \$46 533 per quality-adjusted life year gained with BIAsp 70/30 vs. glargine (for patients with baseline HbA1c >/= 8.5\%, it was \$34 916). Total lifetime costs were compared to efficacy rates in both arms as a ratio, which revealed that the lifetime cost per patient treated successfully to target HbA1c levels of <7.0\% and

Abstract: BACKGROUND: As newer oral diabetes agents continue to emerge on the market, comparative evidence is urgently required to guide appropriate therapy. PURPOSE: To summarize the English-language literature on the benefits and harms of oral agents (second-generation sulfonylureas, biguanides, thiazolidinediones, meglitinides, and alpha-glucosidase inhibitors) in the treatment of adults with type 2 diabetes mellitus. DATA SOURCES: The MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched from inception through January 2006 for original articles and through November 2005 for systematic reviews. Unpublished U.S. Food and Drug Administration and industry data were also searched. STUDY SELECTION: 216 controlled trials and cohort studies and 2 systematic reviews that addressed benefits and harms of oral diabetes drug classes available in the United States. DATA EXTRACTION: Using standardized protocols, 2 reviewers serially abstracted data for each article. DATA SYNTHESIS: Evidence from clinical trials was inconclusive on major clinical end points, such as cardiovascular mortality. Therefore, the review was limited mainly to studies of intermediate end points. Most oral agents (thiazolidinediones, metformin, and repaglinide) improved glycemic control to the same degree as sulfonylureas (absolute decrease in hemoglobin A1c level of about 1 percentage point). Nateglinide and alpha-glucosidase inhibitors may have slightly weaker effects, on the basis of indirect comparisons of placebo-controlled trials. Thiazolidinediones were the only class that had a beneficial effect on high-density lipoprotein cholesterol levels (mean relative increase, 0.08 to 0.13 mmol/L [3 to 5 mg/dL]) but a harmful effect on low-density lipoprotein (LDL) cholesterol levels (mean relative increase, 0.26 mmol/L [10 mg/dL]) compared with other oral agents. Metformin decreased LDL cholesterol levels by about 0.26 mmol/L (10 mg/dL), whereas other oral agents had no obvious effects on LDL cholesterol levels. Most agents other than metformin increased body weight by 1 to 5 kg. Sulfonylureas and repaglinide were associated with greater risk for hypoglycemia, thiazolidinediones with greater risk for heart failure, and metformin with greater risk for gastrointestinal problems compared with other oral agents. Lactic acidosis was no more common in metformin recipients without comorbid conditions than in recipients of other oral diabetes agents. LIMITATIONS: Data on major clinical end points were limited. Studies inconsistently reported adverse events other than hypoglycemia, and definitions of adverse events varied across studies. Some harms not assessed in trials or observational studies may have been overlooked. CONCLUSIONS: Compared with newer, more expensive agents (thiazolidinediones, alpha-glucosidase inhibitors, and meglitinides), older agents (second-generation sulfonylureas and metformin) have similar or superior effects on glycemic control, lipids, and other intermediate end points. Large, long-term comparative studies are needed to determine the comparative effects of oral diabetes agents on hard clinical end points.

 diabetes;  glycemic control;  clinical review;  

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Abstract: BACKGROUND AND RATIONALE: Recent data suggest that insulin glargine might be a cost-effective alternative to conventional insulin therapy in patients with type 2 diabetes mellitus (T2DM). The aim of this observational study was to evaluate the treatment costs of insulin glargine in combination with oral antidiabetic drugs (OADs) compared with conventional insulin therapy in T2DM in everyday clinical practice. PATIENTS AND METHODS: Data were obtained from a cohort of 678 patients with T2DM not adequately controlled by OADs alone (HbA1c mean 9.1 +/- 1.7\%). Patients received either insulin glargine in addition to oral therapy or were switched to conventional insulin therapy. Treatment and dosing decisions were made at the physicians discretion, reflecting everyday practice. Patients were followed for 2-4 months. Primary outcome parameters were total treatment costs and clinical efficacy. RESULTS: The two therapeutic regimens were equally effective in decreasing HbA1c to 7.8\% (p < 10(-9)). Patients in the insulin glargine plus OAD group controlled their blood glucose level at endpoint with a median of 60 test strips per month and those in the conventional insulin therapy group with a median of 80 strips per month (p = 0.000000739). Total daily costs of insulin, needles, glycemic control and OAD treatment per patient were similar in the two treatment groups (insulin glargine group 1.91 Euro vs conventional group 1.99 Euro). CONCLUSION: The two treatment regimens were equally effective in improving glycemic control. These results were achieved with significantly lower insulin doses and fewer blood glucose test strips in the insulin glargine group, which therefore led to cost equivalence when compared with conventional insulin therapy.

 prevention;  diabetes;  glycemic control;  Insulin;  economic evaluation;  

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Abstract: BACKGROUND: The Diabetes Prevention Program (DPP) demonstrated that interventions can delay or prevent the development of type 2 diabetes. OBJECTIVE: To estimate the lifetime cost-utility of the DPP interventions. DESIGN: Markov simulation model to estimate progression of disease, costs, and quality of life. DATA SOURCES: The DPP and published reports. TARGET POPULATION: Members of the DPP cohort 25 years of age or older with impaired glucose tolerance. TIME HORIZON: Lifetime. PERSPECTIVES: Health system and societal. INTERVENTIONS: Intensive lifestyle, metformin, and placebo interventions as implemented in the DPP. OUTCOME MEASURES: Cumulative incidence of diabetes, microvascular and neuropathic complications, cardiovascular complications, survival, direct medical and direct nonmedical costs, quality-adjusted life-years (QALYs), and cost per QALY. RESULTS OF BASE-CASE ANALYSIS: Compared with the placebo intervention, the lifestyle and metformin interventions were estimated to delay the development of type 2 diabetes by 11 and 3 years, respectively, and to reduce the absolute incidence of diabetes by 20% and 8%, respectively. The cumulative incidence of microvascular, neuropathic, and cardiovascular complications were reduced and survival was improved by 0.5 and 0.2 years. Compared with the placebo intervention, the cost per QALY was approximately 1100 dollars for the lifestyle intervention and $31 300 for the metformin intervention. From a societal perspective, the interventions cost approximately 8800 dollars and 29,900 dollars per QALY, respectively. From both perspectives, the lifestyle intervention dominated the metformin intervention. RESULTS OF SENSITIVITY ANALYSIS: Cost-effectiveness improved when the interventions were implemented as they might be in routine clinical practice. The lifestyle intervention was cost-effective in all age groups. The metformin intervention did not represent good use of resources for persons older than 65 years of age. LIMITATIONS: Simulation results depend on the accuracy of the underlying assumptions, including participant adherence. CONCLUSIONS: Health policy should promote diabetes prevention in high-risk individuals.

 prevention;  diabetes;  glycemic control;  economic evaluation;  metformin;  lifestyle;  

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 prevention;  diabetes;  glycemic control;  economic evaluation;  

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Abstract: AIMS/HYPOTHESIS: This study estimated the economic efficiency (1) of intensive blood glucose control and tight blood pressure control in patients with type 2 diabetes who also had hypertension, and (2) of metformin therapy in type 2 diabetic patients who were overweight. METHODS: We conducted cost-utility analysis based on patient-level data from a randomised clinical controlled trial involving 4,209 patients with newly diagnosed type 2 diabetes conducted in 23 hospital-based clinics in England, Scotland and Northern Ireland as part of the UK Prospective Diabetes Study (UKPDS). Three different policies were evaluated: intensive blood glucose control with sulphonylurea/insulin; intensive blood glucose control with metformin for overweight patients; and tight blood pressure control of hypertensive patients. Incremental cost : effectiveness ratios were calculated based on the net cost of healthcare resources associated with these policies and on effectiveness in terms of quality-adjusted life years gained, estimated over a lifetime from within-trial effects using the UKPDS Outcomes Model. RESULTS: The incremental cost per quality-adjusted life years gained (in year 2004 UK prices) for intensive blood glucose control was 6,028 UK pounds, and for blood pressure control was 369 UK pounds. Metformin therapy was cost-saving and increased quality-adjusted life expectancy. CONCLUSIONS/INTERPRETATION: Each of the three policies evaluated has a lower cost per quality-adjusted life year gained than that of many other accepted uses of healthcare resources. The results provide an economic rationale for ensuring that care of patients with type 2 diabetes corresponds at least to the levels of these interventions.

 prevention;  diabetes;  nephropathy;  glycemic control;  Insulin;  economic evaluation;  metformin;  UKPDS;  

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Abstract: BACKGROUND: To reduce the likelihood of complications in persons with type 2 diabetes, it is critical to control hyperglycaemia. Monotherapy with metformin or insulin secretagogues may fail to sustain control after an initial reduction in glycemic levels. Thus, combining metformin with other agents is frequently necessary. These analyses model the potential long-term economic and health impact of using combination therapy to improve glycemic control. METHODS: An existing model that simulates the long-term course of type 2 diabetes in relation to glycosylated haemoglobin (HbA1c) and post-prandial glucose (PPG) was used to compare the combination of nateglinide with metformin to monotherapy with metformin. Complication rates were estimated for major diabetes-related complications (macrovascular and microvascular) based on existing epidemiologic studies and clinical trial data. Utilities and costs were estimated using data collected in the United Kingdom Prospective Diabetes Study (UKPDS). Survival, life years gained (LYG), quality-adjusted life years (QALY), complication rates and associated costs were estimated. Costs were discounted at 6\% and benefits at 1.5\% per year. RESULTS: Combination therapy was predicted to reduce complication rates and associated costs compared with metformin. Survival increased by 0.39 (0.32 discounted) and QALY by 0.46 years (0.37 discounted) implying costs of pound 6,772 per discounted LYG and pound 5,609 per discounted QALY. Sensitivity analyses showed the results to be consistent over broad ranges. CONCLUSION: Although drug treatment costs are increased by combination therapy, this cost is expected to be partially offset by a reduction in the costs of treating long-term diabetes complications.

 prevention;  diabetes;  glycemic control;  economic evaluation;  metformin;  nateglinide;  

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Abstract: OBJECTIVE: The objective of this study was to describe an approach to modeling the efficiency of an intervention by focusing on an established intermediate end point directly. A case study addresses the economic efficiency of obtaining dual glycemic control over time, according to initial choice of treatment. METHODS: From the perspective of a payer in the United States, instead of the usual approach of basing the model on projecting long-term diabetic complications from glycemic control, this model focuses directly on glycemic control. Treatment changes and associated health-care utilization needed to address postprandial glucose. After assigning each of 10000 drug-naive patients, HbA1c, age, race, and sex based on distributions from a randomized clinical trial, the model applies the efficacy of nateglinide compared to metformin. Sensitivity analyses were carried out for all parameters. Costs are reported in year 2000 US dollars and discounted at 3\%. RESULTS: In the base case, starting on nateglinide and increasing the time in dual glycemic control over 3 years by 2.4 months led to savings of US dollars 295 compared to starting on metformin. Savings increased with stricter treatment criteria but decreased if glycemic control was better initially. CONCLUSIONS: This study illustrates the use of an efficiency model that focuses directly on the relevant short-term end point: glycemic control. Starting patients with nateglinide is shown to be an efficient way of obtaining dual glycemic control during the first 3 years of treatment.

 prevention;  diabetes;  glycemic control;  economic evaluation;  metformin;  nateglinide;  

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 prevention;  diabetes;  glycemic control;  economic evaluation;  

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Abstract: OBJECTIVE: Compare the efficacy, safety, and patient satisfaction of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy for patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 132 CSII-naive type 2 diabetic patients were randomly assigned (1:1) to CSII (using insulin aspart) or MDI therapy (bolus insulin aspart and basal NPH insulin) in a multicenter, open-label, randomized, parallel-group, 24-week study. Efficacy was assessed with HbA(1c) and eight-point blood glucose (BG) profiles. Treatment satisfaction was determined with a self-administered questionnaire. Safety assessments included adverse events, hypoglycemic episodes, laboratory values, and physical examination findings. RESULTS: HbA(1c) values decreased similarly for both groups from baseline (8.2 +/- 1.37% for CSII, 8.0 +/- 1.08% for MDI) to end of study (7.6 +/- 1.22% for CSII, 7.5 +/- 1.22% for MDI). The CSII group showed a trend toward lower eight-point BG values at most time points (only significant 90 min after breakfast; 167 +/- 48 vs. 192 +/- 65 mg/dl for CSII and MDI, respectively; P = 0.019). A total of 93% of CSII-treated subjects preferred the pump to their previous injectable insulin regimen for reasons of convenience, flexibility, ease of use, and overall preference. Safety assessments were comparable for both treatment groups. CONCLUSIONS: Insulin aspart in CSII therapy provided efficacy and safety comparable to MDI therapy for type 2 diabetes. Patients with type 2 diabetes can be trained as outpatients to use CSII and prefer CSII to injections, indicating that pump therapy should be considered when initiating intensive insulin therapy for type 2 diabetes.

 prevention;  diabetes;  glycemic control;  Insulin;  clinical trial;  

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Abstract: BACKGROUND: Type 2 diabetes mellitus is a common disease whose complications have great costs, both in quality of life and expense of treatment. Improving glycemic control, as measured by monitoring glycosylated hemoglobin (HbA1c) levels, can reduce the rate of such complications. OBJECTIVES: The aims of this study were to estimate the lifetime costs associated with diabetes-related complications in a theoretical population receiving metformin monotherapy and to predict the health and economic effect of improving glycemic control in this theoretical population by combining metformin with nateglinide. METHODS: A pharmacoeconomic model was developed to simulate the long-term (30 years) complication rates (microvascular and macrovascular) of a cohort of patients with type 2 diabetes mellitus. The model simulated each year of life for each patient in a theoretical cohort of 10,000 patients until diabetes-related complications were present or death occurred. The mean accumulated costs (direct medical costs for acute care and subsequent care for diabetes-related complications), mean survival time, and the frequency of each type of complication were estimated. Both effectiveness and cost data were discounted at 3\%. Sensitivity analyses were conducted on key model input parameters. RESULTS: Average costs of treating complications in theoretical patients undergoing metformin monotherapy were estimated at \$29,565 per patient. Savings of \$2,742 were estimated per patient for all complications--particularly, nephropathy (\$1,166) and macrovascular disease (\$632)--when nateglinide was added. The cost-effectiveness ratio of adding nateglinide to metformin was estimated at \$27,131 per undiscounted life-year gained (95\% CI, \$23,710-\$28,577) or \$43,024 (95\% CI, \$37,285-\$45,193) per additional discounted life-year gained. In the sensitivity analyses, decreasing HbA1c level at baseline, HbA1c upward drift, and duration of disease improved survival. CONCLUSIONS: Combination therapy with nateglinide and metformin, compared with metformin alone, was predicted to reduce the frequency of complications and, thus, treatment costs in this theoretical model. The major factor in cost savings was fewer complications due to nephropathy. The increased drug treatment costs were expected to be offset by the long-term savings from reducing complication rates.

 prevention;  diabetes;  nephropathy;  glycemic control;  economic evaluation;  metformin;  nateglinide;  

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Abstract: CONTEXT: Several treatment interventions can reduce complications of type 2 diabetes, but their relative cost-effectiveness is not known. OBJECTIVE: To estimate the incremental cost-effectiveness of intensive glycemic control (relative to conventional control), intensified hypertension control, and reduction in serum cholesterol level for patients with type 2 diabetes. DESIGN, SETTING, AND PATIENTS: Cost-effectiveness analysis of a hypothetical cohort of individuals living in the United States, aged 25 years or older, who were newly diagnosed as having type 2 diabetes. The results of the United Kingdom Prospective Diabetes Study (UKPDS) and other studies were used to create a model of disease progression and treatment patterns. Costs were based on those used in community practices in the United States. INTERVENTIONS: Insulin or sulfonylurea therapy for intensive glycemic control; angiotensin-converting enzyme inhibitor or beta-blocker for intensified hypertension control; and pravastatin for reduction of serum cholesterol level. MAIN OUTCOME MEASURES: Cost per quality-adjusted life-year (QALY) gained. Costs (in 1997 US dollars) and QALYs were discounted at a 3\% annual rate. RESULTS: The incremental cost-effectiveness ratio for intensive glycemic control is \$41 384 per QALY; this ratio increased with age at diagnosis from \$9614 per QALY for patients aged 25 to 34 years to \$2.1 million for patients aged 85 to 94 years. For intensified hypertension control the cost-effectiveness ratio is -\$1959 per QALY. The cost-effectiveness ratio for reduction in serum cholesterol level is \$51 889 per QALY; this ratio varied by age at diagnosis and is lowest for patients diagnosed between the ages of 45 and 84 years. CONCLUSIONS: Intensified hypertension control reduces costs and improves health outcomes relative to moderate hypertension control. Intensive glycemic control and reduction in serum cholesterol level increase costs and improve health outcomes. The cost-effectiveness ratios for these 2 interventions are comparable with those of several other frequently adopted health care interventions.

 diabetes;  cdc;  glycemic control;  Insulin;  Cholesterol;  UKPDS;  

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Abstract: BACKGROUND: Type 2 diabetes affects approximately 8 percent of adults in the United States. Some risk factors--elevated plasma glucose concentrations in the fasting state and after an oral glucose load, overweight, and a sedentary lifestyle--are potentially reversible. We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes. METHODS: We randomly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo, metformin (850 mg twice daily), or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week. The mean age of the participants was 51 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 34.0; 68 percent were women, and 45 percent were members of minority groups. RESULTS: The average follow-up was 2.8 years. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence by 58 percent (95 percent confidence interval, 48 to 66 percent) and metformin by 31 percent (95 percent confidence interval, 17 to 43 percent), as compared with placebo; the lifestyle intervention was significantly more effective than metformin. To prevent one case of diabetes during a period of three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin. CONCLUSIONS: Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk. The lifestyle intervention was more effective than metformin.

 prevention;  diabetes;  glycemic control;  metformin;  clinical trial;  

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Abstract: OBJECTIVE: To estimate the incremental cost of implementing policies for intensive control of blood glucose concentration and blood pressure for all patients with type 2 diabetes in England. DESIGN: Extrapolation of resource use and cost data derived from a randomised controlled trial. SETTING: General practice, outpatient care, and inpatient care. POPULATION: Trial population with diagnosed type 2 diabetes in England extrapolated to the population of England. MAIN OUTCOME MEASURES: Total costs based on use of healthcare resources including costs of management, treatment, and hospitalisation. RESULTS: The incremental net annual cost of implementing intensive control of blood glucose and blood pressure to all people with diagnosed type 2 diabetes in England is estimated to be pound 100.5m (\$156m; euro;159m), which is equivalent to less than 1\% of the proposed additional annual expenditure on the NHS in 2001-5. This estimate varied in sensitivity analyses from pound 67m to pound 121m. CONCLUSIONS: Policies to improve control of blood glucose and blood pressure of people with type 2 diabetes are effective in reducing complications associated with the disease and are also cost effective. The total cost represents a small fraction of the NHSs spending plans.

 prevention;  diabetes;  nephropathy;  glycemic control;  economic evaluation;  UKPDS;  

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Abstract: AIMS/HYPOTHESIS: This study evaluated the addition of nateglinide, a d-phenylalanine derivative that restores early phase insulin release, to metformin in type 2 diabetes patients stabilized on high-dose metformin. METHODS: This multicentre, double-blind, parallel group trial included 467 metformin-treated patients with glycosylated haemoglobin (HbA1c) between 6.8% and 11%. Patients were randomized to add nateglinide 60 mg, 120 mg or placebo before three meals to metformin 1000 mg b.i.d. for 24 weeks. RESULTS: HbA1c was significantly reduced with nateglinide 60 mg and 120 mg plus metformin compared with metformin control (-0.36%, p = 0.003; -0.59%, p 9.5%). A modest fasting plasma glucose reduction was observed. Most symptoms suggestive of hypoglycaemia occurred in patients with low HbA1c levels (

 

 diabetes;  glycemic control;  metformin;  nateglinide;  clinical trial;  

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Abstract: External insulin infusion (CSII) pumps have regained interest since DCCT, the number of patients approaching 100,000 in the USA. Only 2 manufacturers (Minimed, Disetronic) and 2 insulins (lispro, insuman) are sharing the market. The major advantages over multiple s.c. injections (MDI) are a reduction of nightly instability and hypoglycemia, and time flexibility. Patients poorly controlled under MDI and/or with recurrent hypoglycemias thus represent the best indications. Pumps are predicted to expand in some european countries e.g. France with changes in reimbursement regulations. Implantable insulin pumps are still not commercialized except in few countries e.g. France. Therefore only 1065 pumps have been implanted worldwide so far. The only material available is the Minimed 2007 pump, with the Aventis Genapol insulin. The catheter is intraperitoneal for portal insulin absorption. Metabolic results are better than CSII in terms of glycemic fluctuations and hypoglycemias. Adverse events are limited to catheter obstructions (15\% per patient-year). Ideally, indications should be restricted only to patients with recurrent severe hypoglycemias and/or poor control with CSII because of high cost of the pump (\$ 15,000).

 prevention;  diabetes;  glycemic control;  Insulin;  economic evaluation;  

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Abstract: OBJECTIVE: Glycemic control, perinatal outcome, and health care costs were evaluated among women with type 1 diabetes mellitus who began insulin pump therapy during pregnancy (group 1, n = 24), were treated with multiple insulin injections (group 2, n = 24), or were already using an insulin pump before pregnancy (group 3, n = 12). Patient satisfaction and continuation of pump therapy post partum were assessed. STUDY DESIGN: A retrospective review of maternal and neonatal medical records was performed, and a questionnaire was sent to patients after delivery. Patients in groups 1 and 2 were matched for age, age at onset and duration of diabetes mellitus, White class, and date of delivery. RESULTS: No differences in glycosylated hemoglobin A levels were observed among groups 1, 2 or 3 in the first, second, or third trimester. Patients in group 1 started pump therapy at a mean of 16.8 weeks gestation, and 17 (70.8\%) began therapy as outpatients. No deterioration in glycemic control was noted during the 2- to 4-week period after the start of pump treatment. Among the women in group 1 eight had at least one episode of severe hypoglycemia before starting pump therapy, but only one had such an episode after this treatment was begun. Two episodes of ketoacidosis occurred in group 1, and no episodes occurred in groups 2 and 3. No significant differences in perinatal outcomes or health care costs were observed among groups 1, 2, and 3. After delivery 94. 7\% of the women in group 1 continued to use the pump because it provided better glycemic control and a more flexible lifestyle. Postpartum glycosylated hemoglobin A values were 7.2\% in group 1 and 9.1\% in group 2, a significant difference. CONCLUSIONS: Insulin pump therapy was initiated during pregnancy without a deterioration of glycemic control and was associated with maternal and perinatal outcomes and health care costs comparable to those among women who were already using the pump before pregnancy or who received multiple-dose insulin therapy. Women who began pump therapy in pregnancy were highly likely to continue pump use after delivery and preferred the flexible lifestyle that this treatment allowed.

 prevention;  diabetes;  glycemic control;  Insulin;  economic evaluation;  

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Abstract: To evaluate the cost and effectiveness of intensive insulin therapy for type 2 diabetes on the prevention of diabetes complications in Japan, we performed economic evaluation based on a randomized controlled trial. A total of 110 patients with type 2 diabetes were randomly assigned into two groups, a multiple insulin injection therapy (MIT) group or a conventional insulin injection therapy (CIT) group, and were followed-up for 10 years. Economic evaluation (cost-consequences analysis) was applied to evaluate both health and economic outcomes. As outcome measures for effectiveness of intensive insulin therapy, the frequency of complications, such as retinopathy, nephropathy, neuropathy, macrovascular event, and diabetes-related death, was used. For estimating costs, a viewpoint of the payer (the National Health Insurance) was adopted. Direct medical costs associated with diabetes care during 10 years were calculated and evaluated. In a base case analysis, all costs were discounted to the present value at an annual rate of 3\%. Sensitivity analyses were carried out to assess the robustness of the results to changes in the values of important variables. MIT reduced the relative risk in the progression of retinopathy by 67\%, photocoagulation by 77\%, progression of nephropathy by 66\%, albuminuria by 100\% and clinical neuropathy by 64\%, relative to CIT. Moreover, MIT prolonged the period in which patients were free of complications, including 2.0 years for progression of retinopathy (P<0.0001), 0.3 years for photocoagulation (P<0.05), 1.5 years for progression of nephropathy (P<0.01) and 2.2 years for clinical neuropathy (P<0.0001). The total cost (discounted at 3\%) per patient during the 10-year period for each group was \$30310 and 31525, respectively. The reduction of total costs in MIT over CIT was mainly due to reduced costs for management of diabetic complications. Our results show that MIT is more beneficial than CIT in both cost and effectiveness. Therefore, MIT is recommended for the treatment of type 2 diabetic patients who require insulin therapy as early as possible from the perspective of both patients and health policy.

 prevention;  diabetes;  nephropathy;  glycemic control;  Insulin;  economic evaluation;  KUMAMOTO;  

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Abstract: OBJECTIVE: Compare the cost-effectiveness of self-monitoring of blood glucose (MBG) with your non-use. DESIGN: Descriptive and retrospective study covering the period 1995-97 in the 597 type-2 diabetes patients: 286 practicing MBG on a stable basis and 311 not doing so. All are registered in seven health districts in the territorial ambit of Tortosa Primary Care. Were quantified the direct costs in relation to consumption of reagent strips for the practice of MBG, outpatients visits in your primary care center, derivations to specialist of reference and complementary test according to recommendations of the European NIDDM Policy Group in the population user of MBG and no-user; the annual cost increment, the average annual cost and the total annual cost in the population user of MBG and in the application of a ideal model of quantitative and qualitative cover according to clinical recommendations of the Gedaps; and the cost-effectiveness. RESULTS: While the 78\% of the total diabetic population satisfy some clinical indication for prescribing MBG, only the 42.5\% practice the MBG. The consumption of reagent strips rising of 8\% to 15\% of the global cost of the diabetic population. In the application of the ideal model of cover, this cost increase up the 30\% of global cost. The effectiveness obtained, an 27\%, not are significantly different in the population user of MBG and no user. The cost-effectiveness in the user of MBG increased of 210.789 ptes/year to 213.148 ptes/year; and no-user of 162.019 ptes/year to 162.051 ptes/year. The application of ideal model of cover and the gain of an effectiveness near to possible level of efficiency imply an descent average of cost-effectiveness of approximately 60\%: 78.904 ptes/year in user MBG and 54.682 ptes/year in no-user. CONCLUSIONS: 1. We choose in the presents conditions the option of no-user MBG. 2. The average cost-effectiveness per diabetic patient will increase by the needs of accommodate the therapy to new standards of metabolic control. 3. Are clear opportunity for the improve the management and to motivate an efficient use of technology associate to defects of public sanitary market. 4. The model of ideal cover associated to greater effectiveness are necessary for to unify the economic and clinic efficiency.

 prevention;  diabetes;  glycemic control;  economic evaluation;  SMBG;  

Abstract: OBJECTIVE: To assess the economic efficiency of adding troglitazone to sulfonylurea therapy to improve glycemic control. BACKGROUND: Despite the high prevalence of type 2 diabetes, existing treatment strategies often fail. New oral agents give a wider segment of the population with type 2 diabetes hope of achieving near-normal blood-glucose levels. Troglitazone, a novel chemical entity, is one promising new agent. METHODS: We conducted an economic analysis based on glycemic-control data from a randomized clinical trial comparing troglitazone with placebo, each added to glyburide. A patient simulation model was used to translate these data to long-term outcomes associated with diabetes. Patients had poorly controlled type 2 diabetes mellitus despite glyburide therapy. Risk functions of developing and progressing through nephropathy, retinopathy, neuropathy, hypoglycemia, and macrovascular disease were developed from the Diabetes Control and Complications Trial and large epidemiologic studies. Cost estimates were based on data from 5 states, all payor databases, surveys, and literature. The main outcomes of the model were cost-consequences, number of patients developing each type of complication, mean time to development of the complication, cost per life-year gained (LYG), and cost per quality-adjusted life-year. RESULTS: The model predicts that for every 1000 patients treated with troglitazone, the improved glycemic control could mean that 95 to 140 fewer patients would experience one of the most severe diabetic complications (eg, blindness, end-stage renal disease, amputation), which may increase life expectancy by 2.0 years. These benefits are obtained at an additional \$2100 per LYG (undiscounted). The ratio remains <\$50,000 per LYG for most variations in input. CONCLUSIONS: The clinical trial demonstrated that troglitazone + glyburide improves glycemic control compared with glyburide alone. Based on these results, the model estimates fewer diabetic complications at a cost well below accepted cost-effective thresholds.

 prevention;  diabetes;  nephropathy;  glycemic control;  economic evaluation;  

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Abstract: OBJECTIVE: To evaluate the efficacy and tolerability of nateglinide and metformin alone and in combination in type 2 diabetic patients inadequately controlled by diet, focusing on changes in HbA1c, fasting plasma glucose (FPG), and mealtime glucose excursions. RESEARCH DESIGN AND METHODS: In this randomized double-blind study, patients with an HbA1c level between 6.8 and 11.0% during a 4-week placebo run-in received 24 weeks treatment with 120 mg nateglinide before meals (n = 179), 500 mg metformin three times a day (n = 178), combination therapy (n = 172), or placebo (n = 172). HbA1c and FPG were evaluated regularly, and plasma glucose levels were determined after Sustacal challenge at weeks 0, 12, and 24. Hypoglycemia and other adverse events were recorded. RESULTS: At study end point, HbA1c was reduced from baseline with nateglinide and metformin but was increased with placebo (-0.5, -0.8, and +0.5%, respectively; P < or = 0.0001). Changes in FPG followed the same pattern (-0.7, -1.6, and +0.4 mmol/l; P < or = 0.0001). Combination therapy was additive (HbA1c -1.4% and FPG -2.4 mmol/l; P < or = 0.01 vs. monotherapy). After Sustacal challenge, there was a greater reduction in mealtime glucose with nateglinide monotherapy compared with metformin monotherapy or placebo (adjusted area under the curve [AUC]0-130 min -2.1, -1.1, and -0.6 mmol x h(-1) x l(-1); p < or = 0.0001). An even greater effect was observed with combination therapy (AUC0-130 min -2.5 mmol x h(-1) x l(-1); P < or = 0.0001 vs. metformin and placebo). All regimens were well tolerated. CONCLUSIONS: Nateglinide and metformin monotherapy each improved overall glycemic control but by different mechanisms. Nateglinide decreased mealtime glucose excursions, whereas metformin primarily affected FPG. In combination, nateglinide and metformin had complementary effects, improving HbA1c, FPG, and postprandial hyperglycemia.

 prevention;  diabetes;  glycemic control;  metformin;  nateglinide;  clinical trial;  

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Abstract: OBJECTIVE: To estimate the cost effectiveness of conventional versus intensive blood glucose control in patients with type 2 diabetes. DESIGN: Incremental cost effectiveness analysis alongside randomised controlled trial. SETTING: 23 UK hospital clinic based study centres. PARTICIPANTS: 3867 patients with newly diagnosed type 2 diabetes (mean age 53 years). INTERVENTIONS: Conventional (primarily diet) glucose control policy versus intensive control policy with a sulphonylurea or insulin. Main outcome measures: Incremental cost per event-free year gained within the trial period. RESULTS: Intensive glucose control increased trial treatment costs by pound 695 (95\% confidence interval pound 555 to pound 836) per patient but reduced the cost of complications by pound 957 (pound 233 to pound 1681) compared with conventional management. If standard practice visit patterns were assumed rather than trial conditions, the incremental cost of intensive management was pound 478 (-pound 275 to pound 1232) per patient. The within trial event-free time gained in the intensive group was 0.60 (0.12 to 1.10) years and the lifetime gain 1.14 (0.69 to 1.61) years. The incremental cost per event-free year gained was pound 1166 (costs and effects discounted at 6\% a year) and pound 563 (costs discounted at 6\% a year and effects not discounted). CONCLUSIONS: Intensive blood glucose control in patients with type 2 diabetes significantly increased treatment costs but substantially reduced the cost of complications and increased the time free of complications.

 prevention;  diabetes;  nephropathy;  glycemic control;  Insulin;  economic evaluation;  UKPDS;  

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Abstract: Diabetes mellitus is one of the most common metabolic diseases in many countries of the world. Its prevalence in Germany has increased 7- to 8-fold over the past 30 years. The clinical and economical importance of diabetes is determined by the frequent occurrences of such serious complications as neuropathy, retinopathy and nephropathy. Intensive insulin therapy with regular monitoring of blood glucose (up to 4 measurements daily) and adjustment of the insulin dose accordingly may achieve virtually normal levels of blood glucose and thus decrease the risk of these complications. The present cost-effectiveness-study shows that the higher costs of invasive insulin therapy are offset by savings of 8.114 German marks per patient resulting from the reduction in morbidity and mortality. On the basis of an estimated 5\% to 10\% type 1 diabetes among the total diabetic population (prevalence 4.9\%), potential saving of 1.62 to 3.24 billion marks are calculated for Germany.

 prevention;  diabetes;  nephropathy;  glycemic control;  Insulin;  economic evaluation;  DCCT;  

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Abstract: BACKGROUND: Improved blood-glucose control decreases the progression of diabetic microvascular disease, but the effect on macrovascular complications is unknown. There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation. We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a randomised controlled trial. METHODS: 3867 newly diagnosed patients with type 2 diabetes, median age 54 years (IQR 48-60 years), who after 3 months diet treatment had a mean of two fasting plasma glucose (FPG) concentrations of 6.1-15.0 mmol/L were randomly assigned intensive policy with a sulphonylurea (chlorpropamide, glibenclamide, or glipizide) or with insulin, or conventional policy with diet. The aim in the intensive group was FPG less than 6 mmol/L. In the conventional group, the aim was the best achievable FPG with diet alone; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment: any diabetes-related endpoint (sudden death, death from hyperglycaemia or hypoglycaemia, fatal or non-fatal myocardial infarction, angina, heart failure, stroke, renal failure, amputation [of at least one digit], vitreous haemorrhage, retinopathy requiring photocoagulation, blindness in one eye, or cataract extraction); diabetes-related death (death from myocardial infarction, stroke, peripheral vascular disease, renal disease, hyperglycaemia or hypoglycaemia, and sudden death); all-cause mortality. Single clinical endpoints and surrogate subclinical endpoints were also assessed. All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy. FINDINGS: Over 10 years, haemoglobin A1c (HbA1c) was 7.0% (6.2-8.2) in the intensive group compared with 7.9% (6.9-8.8) in the conventional group--an 11% reduction. There was no difference in HbA1c among agents in the intensive group. Compared with the conventional group, the risk in the intensive group was 12% lower (95% CI 1-21, p=0.029) for any diabetes-related endpoint; 10% lower (-11 to 27, p=0.34) for any diabetes-related death; and 6% lower (-10 to 20, p=0.44) for all-cause mortality. Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25% risk reduction (7-40, p=0.0099) in microvascular endpoints, including the need for retinal photocoagulation. There was no difference for any of the three aggregate endpoints between the three intensive agents (chlorpropamide, glibenclamide, or insulin). Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis (both p<0.0001). The rates of major hypoglycaemic episodes per year were 0.7% with conventional treatment, 1.0% with chlorpropamide, 1.4% with glibenclamide, and 1.8% with insulin. Weight gain was significantly higher in the intensive group (mean 2.9 kg) than in the conventional group (p<0.001), and patients assigned insulin had a greater gain in weight (4.0 kg) than those assigned chlorpropamide (2.6 kg) or glibenclamide (1.7 kg). INTERPRETATION: Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications, but not macrovascular disease, in patients with type 2 diabetes.(ABSTRACT TRUNCATED)

 diabetes;  glycemic control;  Insulin;  clinical trial;  UKPDS;  

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Abstract: Treatment of diabetic complications consumes health care resources. Intensive therapy was shown by the Diabetes Control and Complications Trial (DCCT) to avert complications. Economic analyses and models have been used to evaluate the cost-effectiveness of intensive therapy for people with type 1 and type 2 diabetes. An economic analysis of the DCCT estimated the cost of intensive therapy to be two to three times greater than that of conventional therapy. In contrast, an economic model predicts that intensive therapy, as compared with conventional therapy, could reduce blindness from 34 to 20\% or by 41\%, end-stage renal disease from 24 to 7\% or by 71\%, and lower-extremity amputations from 7 to 4\% or by 43\%. Although intensive therapy is more expensive, when the costs of complications are factored in, it becomes cost-effective for treatment of type 1 diabetes. Similarly, a model to evaluate the cost-effectiveness of intensive therapy for people with type 2 diabetes found that the lifetime costs of general and diabetes-related medical care would be approximately two times greater. However, the reduction in lifetime costs of complications, which would produce substantial reductions in costs of treatment, largely offsets the difference. Intensive therapy for type 1 and type 2 diabetes may be more expensive than conventional therapy, but from an economic perspective, it is comparable in cost to pharmacological therapies for people with hypertension and hypercholesterolemia. From a health system viewpoint, intensive therapy represents a fruitful long-term financial investment.

 prevention;  diabetes;  nephropathy;  glycemic control;  economic evaluation;  DCCT;  

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Abstract: Sorry no abstract available for this article

 prevention;  diabetes;  nephropathy;  glycemic control;  economic evaluation;  DCCT;  

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Abstract: OBJECTIVE: To examine the cost-effectiveness of alternative approaches to the management of insulin-dependent diabetes mellitus (IDDM). DESIGN: A Monte Carlo simulation model was developed to estimate the lifetime benefits and costs of conventional and intensive insulin therapy. Data were collected as part of the Diabetes Control and Complications Trial (DCCT) and supplemented with data from other clinical trials and epidemiologic studies. SETTING: Twenty-nine academic medical centers. PATIENTS: Persons with IDDM in the United States who meet demographic and clinical eligibility criteria for enrollment in the DCCT. INTERVENTIONS: Conventional vs intensive diabetes management. RESULTS: Approximately 120 000 persons with IDDM in the United States meet DCCT eligibility criteria. Implementing intensive rather than conventional therapy in this population would result in a gain of 920 000 years of sight, 691 000 years free from end-stage renal disease, 678 000 years free from lower extremity amputation, and 611 000 years of life at an additional cost of \$4.0 billion over the lifetime of the population. The incremental cost per year of life gained is \$28 661. CONCLUSIONS: Over a lifetime, DCCT-defined intensive therapy reduces complications, improves quality of life, and can be expected to increase length of life. From a health care system perspective, intensive therapy is well within the range of cost-effectiveness considered to represent a good value.

 prevention;  diabetes;  nephropathy;  glycemic control;  Insulin;  economic evaluation;  DCCT;  

Abstract: At the Department of Veterans Affairs Outpatient Clinic in Columbus, Ohio, patients with non-insulin-dependent diabetes mellitus who were receiving glipizide therapy were converted to glyburide therapy over a 6-month period starting in mid-1993. A pharmacy follow-up clinic was instituted to help patients with problems associated with the transition. The conversion was intended to reduce costs by converting from a more expensive to a less expensive drug (in terms of acquisition cost) within the same therapeutic class. An initial analysis of the conversion indicated a savings of \$65,000.00 to the Department of Veterans Affairs (VA) based on the drug acquisition cost differential alone. The purpose of our study was to retrospectively evaluate the cost-effectiveness of the conversion and pharmacy follow-up clinic from the perspective of the VA pharmacy department. Relevant costs and effectiveness (percentage of patients who achieved good glycemic control) were examined for three groups: group I--patients who were treated with glipizide, group II--patients who were treated with glipizide; group II--patients who were switched from glipizide to glyburide, accompanied by a pharmacy follow-up clinic; and group III--patients who were switched from glipizide to glyburide, with no follow-up clinic. Overall, group II had the lowest costs, and group II had to be the most effective. Cost-II effectiveness analysis indicated that, in general, the conversion from glipizide to glyburide was cost-effective. Incremental analysis performed for the follow-up group over the no follow-up group showed that for every 1\% of patients who achieved good glycemic control, the VA would spend \$1.01 more for the follow-up groups. This was considered to be cost-effective for the VA.

 prevention;  diabetes;  glycemic control;  economic evaluation;  

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Abstract: To examine whether intensive glycemic control could decrease the frequency or severity of diabetic microvascular complications, we performed a prospective study of Japanese patients with non-insulin-dependent diabetes mellitus (NIDDM) treated with multiple insulin injection treatment. A total of 110 patients with NIDDM was randomly assigned to multiple insulin injection treatment group (MIT group) or to conventional insulin injection treatment group (CIT group). Fifty-five NIDDM patients who showed no retinopathy and urinary albumin excretions < 30 mg/24 h at the baseline were evaluated in the primary-prevention cohort, and the other 55 NIDDM patients who showed simple retinopathy and urinary albumin excretions < 300 mg/24 h were evaluated in the secondary-intervention cohort. The appearance and the progression of retinopathy, nephropathy and neuropathy were evaluated every 6 months over a 6-year period. The worsening of complications in this study was defined as an increase of 2 or more steps in the 19 stages of the modified ETDRS interim scale for retinopathy and an increase of one or more steps in 3 stages (normoalbuminuria, microalbuminuria and albuminuria) for nephropathy. The cumulative percentages of the development and the progression in retinopathy after 6 years were 7.7% for the MIT group and 32.0% for the CIT group in the primary-prevention cohort (P = 0.039), and 19.2% for MIT group and 44.0% for CIT group in the secondary-intervention cohort (P = 0.049). The cumulative percentages of the development and the progression in nephropathy after 6 years were 7.7% for the MIT group and 28.0% for the CIT group in the primary-prevention cohort (P = 0.032), and 11.5% and 32.0%, respectively, for the MIT and CIT groups in the secondary-intervention cohort (P = 0.044). In neurological tests after 6 years, MIT group showed significant improvement in the nerve conduction velocities, while the CIT group showed significant deterioration in the median nerve conduction velocities and vibration threshold. Although both postural hypotension and the coefficient of variation of R-R interval tended to improve in the MIT group, they deteriorated in the CIT group. In conclusion, intensive glycemic control by multiple insulin injection therapy can delay the onset and the progression of diabetic retinopathy, nephropathy and neuropathy in Japanese patients with NIDDM. From this study, the glycemic threshold to prevent the onset and the progression of diabetic microangiopathy is indicated as follows; HbA1c < 6.5%, FBG < 110 mg/dl, and 2-h post-prandial blood glucose concentration < 180 mg/dl.

 diabetes;  glycemic control;  clinical trial;  KUMAMOTO;  

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Abstract: OBJECTIVE--To investigate if intraperitoneal (IP) insulin infusion via programmable implantable pumps is a potential alternative to subcutaneous (SC) insulin via multiple injections. RESEARCH DESIGN AND METHODS--We compared the cost-benefits of the two methods using a randomized, prospective, 6-month, crossover design in 10 adult type I diabetic patients. RESULTS--When judged on the last month of IP versus SC periods in the nine patients who completed the study, metabolic data showed better glycemic control (HbA1c: 7.2 +/- 0.2 IP vs. 8.5 +/- 0.7\% SC, mean +/- SE, P = 0.02), reduced glycemic fluctuations (SD of capillary glucose values: 3.4 +/- 0.2 IP vs. 4.6 +/- 0.2 mM SC, P < 0.01), and fewer mild hypoglycemic events (5.7 +/- 2.0 IP vs. 10.0 +/- 3.1 events/month SC, P = 0.02). Quality of life, judged by Diabetes Control and Complications Trial questionnaires, was unaffected by pump therapy. Direct costs, including pump acquisition, implantation, and follow-up, were 2.6-fold higher with IP than with SC delivery. CONCLUSIONS--The implantable pump is more effective in the short term, equally accepted, but more costly than multiple injections and should be limited to patients with unsatisfactory glycemic control despite intensive diabetes management with SC insulin. In addition, longer-term, larger-scale, and comparative evaluation is required.

 prevention;  diabetes;  glycemic control;  Insulin;  economic evaluation;