Complications Trial (complications + trial)

Distribution by Scientific Domains


Selected Abstracts


Insulin therapy and quality of life.

DIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue S1 2009
A review
Abstract Three central goals in the treatment of diabetes mellitus are (1) the avoidance of hyperglycaemia to prevent the development or progression of diabetes complications over time, (2) the avoidance of hypoglycaemia and (3) the maintenance or achievement of good quality of life. Insulin is the most powerful agent that can be used to control blood glucose levels. This article reviews the studies that have investigated the effects of different types of insulin and insulin delivery techniques on quality of life of patients with type 1 or type 2 diabetes. First, the concept of ,quality of life' (QoL) is defined and different ways of measuring QoL are explained. Secondly, the effects of different aspects of insulin therapy on QoL are reviewed: (1) the phenomenon of ,psychological insulin resistance'; (2) the effects of different types of insulin: regular insulin versus short-acting insulin analogues, long-acting insulin analogues or biphasic mixtures; (3) multiple daily injections versus pump therapy. Having multiple complications of diabetes is clearly associated with decreased QoL. Results from large studies such as the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) suggest that intensive treatment itself does not impair QoL. Recent findings further suggest that pump therapy, compared to multiple daily injections, has beneficial effects on QoL. The fact that multiple tools are used to assess QoL makes it difficult to draw conclusions regarding the effects of different types of insulin on QoL. More work on the standardization of the assessment of QoL in diabetes is urgently needed. Copyright © 2009 John Wiley & Sons, Ltd. [source]


Insulin therapy in Europe

DIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue S3 2002
Werner A. Scherbaum
Abstract The prevalence of type 1 diabetes is rising in all European countries, particularly in Scandinavia and the UK. Insulin therapy in Europe is strongly influenced by the results of the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), both of which showed the importance of tight metabolic control in patients with diabetes. The importance of tight glycemic control is also emphasized in the Saint Vincent Declaration, which established 5-year goals for antidiabetic therapy in Europe. Insulin therapy in Europe has been significantly improved over the past 10,years, owing to a number of developments. These include increased use of intensive insulin therapy in patients with type 1 diabetes; the development of new insulin analogs, including insulin glargine for injection therapy and short-acting agents that are particularly suitable for use in pumpsand the establishment of comprehensive and standardized treatment goals and guidelines. Nevertheless, important obstacles must still be overcome to optimize therapy for patients with diabetes and reduce the long-term complications of this disease. These obstacles include low public awareness of diabetes and its symptoms, training of physicians as well as patients that is often insufficient to ensure adherence to professional guidelines for diabetes care, and limitations in communication among professional care providers. Copyright © 2002 John Wiley & Sons, Ltd. [source]


Stratified analyses for selecting appropriate target patients with diabetic peripheral neuropathy for long-term treatment with an aldose reductase inhibitor, epalrestat

DIABETIC MEDICINE, Issue 7 2008
N Hotta
Abstract Aims The long-term efficacy of epalrestat, an aldose reductase inhibitor, in improving subjective symptoms and nerve function was comprehensively assessed to identify patients with diabetic peripheral neuropathy who responded to epalrestat treatment. Methods Stratified analyses were conducted on data from patients in the Aldose Reductase Inhibitor,Diabetes Complications Trial (ADCT). The ADCT included patients with diabetic peripheral neuropathy, median motor nerve conduction velocity , 40 m/s and with glycated haemoglobin (HbA1c) , 9.0%. Longitudinal data on HbA1c and subjective symptoms of the patients for 3 years were analysed (epalrestat n = 231, control subjects n = 273). Stratified analyses based on background variables (glycaemic control, grades of retinopathy or proteinuria) were performed to examine the relationship between subjective symptoms and nerve function. Multiple logistic regression analyses were conducted. Results Stratified subgroup analyses revealed significantly better efficacy of epalrestat in patients with good glycaemic control and less severe diabetic complications. In the control group, no improvement in nerve function was seen regardless of whether symptomatic benefit was obtained. In the epalrestat group, nerve function deteriorated less or improved in patients whose symptoms improved. The odds ratio of the efficacy of epalrestat vs. control subjects was approximately 2 : 1 (4 : 1 in patients with HbA1c , 7.0%). Conclusion Our results suggest that epalrestat, an aldose reductase inhibitor, will provide a clinically significant means of preventing and treating diabetic neuropathy if used in appropriate patients. [source]


HbA1c as a screening tool for detection of Type 2 diabetes: a systematic review

DIABETIC MEDICINE, Issue 4 2007
C. M. Bennett
Abstract Aim To assess the validity of glycated haemoglobin A1c (HbA1c) as a screening tool for early detection of Type 2 diabetes. Methods Systematic review of primary cross-sectional studies of the accuracy of HbA1c for the detection of Type 2 diabetes using the oral glucose tolerance test as the reference standard and fasting plasma glucose as a comparison. Results Nine studies met the inclusion criteria. At certain cut-off points, HbA1c has slightly lower sensitivity than fasting plasma glucose (FPG) in detecting diabetes, but slightly higher specificity. For HbA1c at a Diabetes Control and Complications Trial and UK Prospective Diabetes Study comparable cut-off point of , 6.1%, the sensitivity ranged from 78 to 81% and specificity 79 to 84%. For FPG at a cut-off point of , 6.1 mmol/l, the sensitivity ranged from 48 to 64% and specificity from 94 to 98%. Both HbA1c and FPG have low sensitivity for the detection of impaired glucose tolerance (around 50%). Conclusions HbA1c and FPG are equally effective screening tools for the detection of Type 2 diabetes. The HbA1c cut-off point of > 6.1% was the recommended optimum cut-off point for HbA1c in most reviewed studies; however, there is an argument for population-specific cut-off points as optimum cut-offs vary by ethnic group, age, gender and population prevalence of diabetes. Previous studies have demonstrated that HbA1c has less intra-individual variation and better predicts both micro- and macrovascular complications. Although the current cost of HbA1c is higher than FPG, the additional benefits in predicting costly preventable clinical complications may make this a cost-effective choice. [source]


What is the impact of PRIME on real-life diabetic nephropathy?

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 3 2004
L. M. Ruilope
Summary Type 2 diabetes is increasing globally and is a major cause of conditions such as cardiovascular disease, retinopathy and nephropathy. The Diabetes Control and Complications Trial and the UK Prospective Diabetes Study demonstrated that the progression of renal disease could be slowed by tight glycaemic control and treating any associated hypertension with angiotensin-converting enzyme inhibition. Recent clinical trials have supported the use of angiotensin II receptor antagonists in the treatment of diabetic nephropathy, resulting in the approval of new therapeutic indications in the United States and Europe. The objective of this review is to demonstrate how results from the Program for Irbesartan Mortality and morbidity Evaluation studies apply to clinical practice, and to show how the benefits of irbesartan therapy can be realised at any stage of renal disease in patients with diabetes. [source]


An expanded role for dietitians in maximising retention in nutrition and lifestyle intervention trials: implications for clinical practice

JOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2010
L. M. Delahanty
Abstract The demand for clinical trials targeting lifestyle intervention has increased as a result of the escalation in obesity, diabetes mellitus and cardiovascular disease. Little is published about the strategies that dietitians have used to successfully screen potential study volunteers, implement interventions and maximise adherence and retention in large multicentre National Institutes of Health funded nutrition and lifestyle intervention clinical trials. This paper discusses an expanded role for the contributions of dietitians as members of an interdisciplinary team based on research experiences in the Diabetes Control and Complications Trial, Diabetes Prevention Program and Look AHEAD (Action for Health in Diabetes). Many of the strategies and insights discussed are also relevant to effective clinical practice. Dietitians need to broaden their scope of practice so that they are integrated proactively into the screening and intervention phases of large clinical trials to maximise retention and adherence to assigned nutrition, lifestyle and behavioural interventions. The skills of dietitians are a unique fit for this work and it is important that investigators and project managers consider including them in both the screening and intervention phases of such clinical trials to maximise retention results. [source]


Contemporary Australian outcomes in childhood and adolescent type 1 diabetes: 10 years post the Diabetes Control and Complications Trial

JOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 7-8 2006
Geoffrey R Ambler
Abstract: The reporting of the results of the Diabetes Control and Complications Trial in 1993 has led to a major reappraisal of management practices and outcomes in type 1 diabetes in children and adolescents. A considerable body of outcome data has been generated from Australia in this post-Diabetes Control and Complications Trial era relating to incidence, metabolic control, growth, hypoglycaemia, microvascular and macrovascular complications, cognition, behaviour and quality of life. These data are important in planning future management strategies and resource allocation and as a basis for future research. [source]


Meeting American Diabetes Association Guidelines In Endocrinologist Practice

JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 2 2000
C.D. Miller
OBJECTIVE,To determine whether American Diabetes Association (ADA) guidelines can be met in the context of routine endocrinology practice. RESEARCH DESIGN AND METHODS,Charts were reviewed for a group of patients who were examined in 1998, followed for greater than or equal to 1 year, and had two or more visits during that year. Process measures and metabolic outcomes were studied for patients with type 2 diabetes, and glycemic control was assessed for patients with type 1 diabetes. RESULTS,A total of 1.21 patients with type 2 diabetes had a mean age of 63 years, a mean BMI of 31 kg/m(2), and a mean duration of diabetes of 12 years. Many had comorbidities or complications: 80% had hypertension, 64% had hyperlipidemia, 78% had neuropathy, 22% had retinopathy, and 21% had albuminuria. Management of type 2 diabetic patients was complex: 38% used oral hypoglycemic agents alone (54% of these were using two or more agents), 31% used oral hypoglycemic agents and insulin, and 26% used insulin alone, 42% of patients taking insulin therapy injected insulin three or more times per day. Within 12 months, 74% of patients had dilated eye examinations, 70% had lipid profiles, and 55% had urine albumin screening. Of the patients, 87% had a foot examination at their last visit. Blood pressure levels averaged 133/72 mmHg, cholesterol levels averaged 4.63 mmol/l, triglyceride levels averaged 1.99 mmol/l. HDL cholesterol levels averaged 1.24 mmol/l, and LDL cholesterol levels averaged 2.61. mmol/l. Random blood glucose levels averaged 8.0 mmol/l, and HbA(1c) levels averaged 6.9 +/, 0.1%. A total of 87% of patients had HbA(1c) levels less than or equal to 8.0%. A total of 30 patients with type 1 diabetes had mean age of 44 years, a mean BMI of 26 kg/m(2), and a mean duration of diabetes of 20 years. All type 1 diabetic patients used insulin and averaged 3.4 injections a day, their average HbA(1c) level was 7.1 +/, 0.2%, and 80% had HbA(1c) levels less than or equal to 8.0%. CONCLUSIONS,Although endocrinologists must manage patients with multifaceted problems, complex treatment regimens yield glycemic control levels comparable with the Diabetes Control and Complications Trial and allow ADA guidelines to be met in a routine practice setting. [source]


Past, present, and future of insulin pump therapy: better shot at diabetes control

MOUNT SINAI JOURNAL OF MEDICINE: A JOURNAL OF PERSONALIZED AND TRANSLATIONAL MEDICINE, Issue 4 2008
Jennifer Sherr MD
Abstract With the advent of continuous subcutaneous insulin infusion therapy and the findings of the Diabetes Control and Complications Trial, the management of type 1 diabetes has changed drastically. Over the past 30 years since its development, the effectiveness of continuous subcutaneous insulin infusion has been assessed in comparison with other modes of intensive treatment. Additionally, improvements in pump delivery systems have been made. Here, the findings of the studies on pump therapy are reviewed. Selection criteria of patients for pump use and how to initiate pump therapy are presented. Finally, newer findings on continuous glucose sensors are discussed as the next era of pump therapy continues to focus on the goal of developing an artificial pancreas. Mt Sinai J Med 75:352,361, 2008. © 2008 Mount Sinai School of Medicine [source]


Characteristics of glycemic control in young children with type 1 diabetes

PEDIATRIC DIABETES, Issue 4 2002
Francine Ratner Kaufman
Abtract: Background: The Diabetes Control and Complications Trial (DCCT) demonstrated that the rate-limiting step to the intensification of diabetes management in adolescents and adults was hypoglycemia. Young children were presumed to be at even greater risk for hypoglycemia with severe consequences, particularly if they had HbA1c levels < 8%. Subjects: A retrospective chart review was performed on 148 patients with type 1 diabetes on insulin injection therapy who were < 8 yr of age (mean age 5.7 ± 1.5, mean diabetes duration 3.0 ± 1.4 yr) followed quarterly from July 1999 to June 2001. Methods:, The subjects were divided into two groups based on their mean HbA1c values (< 8 vs. , 8%) averaged over the 2-yr time period. The following variables were analyzed comparing the two groups: age, duration of diabetes, insulin dose, severe hypoglycemic episodes, episodes of diabetic ketoacidosis (DKA), percentage of glucose levels above, within, and below the target range, and number of diabetes home-management competencies obtained. Results:, Patients with HbA1c < 8% spent more time within target range (40.0 vs. 29.5%, p = 0.0001) and less time above their target range (36.9 vs. 51.2%, p = 0.0003). There was no difference in the percentage of glucose levels below target (23.2 vs. 19.4%, p = NS), percentage of severe hypoglycemic episodes (3 vs. 7 episodes per 100 patient-yr, p = NS), or episodes of DKA (1 vs. 3 episodes per 100 patient-yr, p = NS) between the two groups. Subjects with lower HbA1c levels had acquired more home-management competencies (4.0 vs. 3.5, p = 0.01). Conclusions:, If families are competent in fundamental diabetes management, young children can achieve HbA1c levels < 8.0% without increasing the risk of hypoglycemia. [source]


Risk factors for visual impairment registration due to diabetic retinopathy in Leeds, 2002,2005

PRACTICAL DIABETES INTERNATIONAL (INCORPORATING CARDIABETES), Issue 3 2009
Diabetes & Endocrinology, H Hayat Specialist Registrar
Abstract We undertook a retrospective study of case notes of those patients registered blind or partially sighted due to diabetic retinopathy in the Leeds metropolitan area in the years 2002 and 2005. Both the incidence of visual impairment due to diabetic retinopathy and the relative contribution to total registrations are similar to those observed in other local and national studies. The main risk factors for registered visual impairment were poor glycaemic control prior to ophthalmic review, no prior retinopathy screening, late presentation with symptomatic visual loss, non-compliance with planned review and laser treatment failure. Most of these risk factors are avoidable. Nearly two-thirds of patients diagnosed with diabetes mellitus were being screened for diabetic retinopathy. These figures would suggest that the National Service Framework for Diabetes' proposed coverage of 80% by 2006 and 100% by the end of 2007 is achievable. The duration of diagnosed diabetes mellitus at the time of registration was an average of 16 years in this study. This reflects the slow development of sight-threatening retinopathy and visual loss observed previously. Conventional therapy for diabetic retinopathy with laser photocoagulation reduces the risk of visual loss more effectively than it improves visual function. Despite the increased risk of early worsening of retinopathy seen with intensive glycaemic control in the Diabetes Control and Complications Trial and the UK Prospective Diabetes Study, improved control closer to the time of diagnosis of diabetes mellitus would have helped to provide a sustained reduction in the risk of retinopathy developing or progressing. Both laser treatment failure and non-attendance may limit the benefits of improved screening coverage. Copyright © 2009 John Wiley & Sons. [source]