A multicentre randomized controlled trial of an empowerment-inspired intervention for adolescents starting continuous subcutaneous insulin infusion : a study protocol

Background. Continuous subcutaneous insulin infusion (CSII) treatment among children with type 1 diabetes is increasing in Sweden. However, studies evaluating glycaemic control in children using CSII show inconsistent results. Omitting bolus insulin doses using CSII may cause reduced glycaemic control among adolescents. The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification. There is much published support for continued parental involvement and shared diabetes management during adolescence. Guided Self-Determination (GSD) is an empowerment-based, person-centred, reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management. This method has been adapted for adolescents and parents as Guided Self-Determination-Young (GSD-Y). This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts, perceived health and quality of life (QoL), and metabolic control. Here, we describe the protocol and plans for study enrolment. Methods. This study is designed as a randomized, controlled, prospective, multicentre study. Eighty patients between 12-18 years of age who are planning to start CSII will be included. All adolescents and their parents will receive standard insulin pump training. The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII. The primary outcome is haemoglobin A1c levels. Secondary outcomes are perceived health and QoL, frequency of blood glucose self-monitoring and bolus doses, and usage of carbohydrate counting. The following instruments will be used to evaluate perceived health and QoL: Disabkids, 'Check your health', the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale. Outcomes will be evaluated within and between groups by comparing data at baseline, and at 6 and 12 months after starting treatment. Results and discussion. In this study, we will assess the effect of starting an insulin pump together with the model of Guided Self-Determination to determine whether this approach leads to retention of improved glycaemic control, QoL, responsibility distribution and reduced diabetes-related conflicts in the family. Trial registration: Current controlled trials: ISRCTN22444034

Community center-based resistance training for the maintenance of glycemic control in adults with type 2 diabetes

OBJECTIVE--The purpose of this study Was to determine whether beneficial effects on glycemic control of an initial laboratory-supervised resistance training program could be sustained through a community center-based maintenance program.

RESEARCH DESIGN AND METHODS--We studied 57 overweight (BMI [greater than or equal to] 27 kg/[m.sup.2]) sedentary men and women aged 40-80 years with established (>6 months) type 2 diabetes. Initially, all participants attended a twice-weekly 2-month supervised resistance training program conducted in the exercise laboratory. Thereafter, participants undertook a resistance training maintenance program (2 times/week) for 12 months and were randomly assigned to carry this out either in a community fitness and recreation center (center) or in their domestic environment (home). Glycemic control ([HbA.sub.1c] [A1C]) was assessed at 0, 2, and 14 months.

RESULTS--Pooling data from the two groups for the 2-month supervised resistance training program showed that compared with baseline, mean A1C fell by -0.4% [95% CI -0.6 to -0.2]. Within-group comparisons showed that A1C remained lower than baseline values at 14 months in the center group (-0.4% [-0.7 to -0.03]) but not in the home group (-0.1% [-0.4 to 0.3]). However, no between-group differences were observed at each time point. Changes in A1C during the maintenance period were positively associated with exercise adherence in the center group only.

CONCLUSIONS--Center-based but not home-based resistance training was associated with the maintenance of modestly improved glycemic control from baseline, which was proportional to program adherence. Our findings emphasize the need to develop and test behavioral methods to promote healthy lifestyles including increased physical activity in adults with type 2 diabetes.

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

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.

'Mind and body' : a lifestyle programme for people on antipsychotic medication

Rationale Psychiatric illnesses such as schizophrenia and their treatments have consequences in terms of lifestyle, diet and weight.

Aims and objectives ‘Mind and Body’ is a 10-week programme of weekly sessions aimed to improve the health status of people treated with second generation antipsychotic medications.

Methods The programme focuses on a range of lifestyle strategies including diet and exercise and was conducted at a Community Health Centre by professionally qualified staff. Between 2002 and 2006, 50 participants enrolled in, and 30 completed the programme. Measures of body weight, health status (Short Form-36) and blood markets (plasma glucose, haemoglobin A1c and lipid profile) were collected at commencement and completion of the programme.

Results A modest improvement was demonstrated in mean values for the majority of measures collected.

Conclusions A lifestyle program for people treated with antipsychotic medications is achievable and may be worthwhile although gains may be modest.

Reducing risk in coronary artery disease. Are Australian patients in general practice achieving targets? The coronary artery disease in general practice study (CADENCE)

Background The benefits of secondary preventive measures for stable coronary artery disease are well established and risk factor treatment targets are defined.

Aim The aim of this study was to examine Australian general practitioners' (GP) perception and management of risk factors in chronic stable angina patients in primary care.

Methods Using a cluster-stratified design, 2031 consecutive stable angina patients were recruited between October 2006 and March 2007 by 207 GP who documented their risk factors and reported if they were optimally controlled.

Results Among the patients, 93% had objective evidence of coronary artery disease and 63% were male, and mean age was 71 ± 11 years. Based upon national guidelines, recommended targets were achieved in: 60% for blood pressure, 24% for body mass index, 23% for waist circumference, 17% for lipid profiles (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides) and 54% of diabetics for haemoglobin A1c. However, GP perceived risk factors to be ‘optimally controlled’ in: 86% for blood pressure (kappa statistic (κ) = 0.37), 44% for weight (κ = 0.3), 70% for lipids (κ = 0.20) and 60% for haemoglobin A1c (κ = 0.74).

Conclusions In this representative cohort of chronic stable angina patients attending GP, cardiovascular risk factor control was frequently suboptimal despite being perceived as satisfactory by the clinicians. New strategies that raise awareness and address this treatment gap need to be implemented.

Prevention of diabetes in rural India with a telemedicine intervention

Background : Diabetes care is not presently available, accessible, or affordable to people living in rural areas in developing countries, such as India. The Chunampet Rural Diabetes Prevention Project (CRDPP) was conceived with the aim of implementing comprehensive diabetes screening, prevention, and treatment using a combination of telemedicine and personalized care in rural India.

Methods : This project was undertaken in a cluster of 42 villages in and around the Chunampet village in the state of Tamil Nadu in southern India. A telemedicine van was used to screen for diabetes and its complications using retinal photography, Doppler imaging, biothesiometry, and electrocardiography using standardized techniques. A rural diabetes center was set up to provide basic diabetes care.

Results : Of the total 27,014 adult population living in 42 villages, 23,380 (86.5%) were screened for diabetes, of which 1138 (4.9%) had diabetes and 3410 (14.6%) had prediabetes. A total of 1001 diabetes subjects were screened for complications (response rate of 88.0%). Diabetic retinopathy was detected in 18.2%, neuropathy in 30.9%, microalbuminuria in 24.3%, peripheral vascular disease in 7.3%, and coronary artery disease in 10.8%. The mean hemoglobin A1c levels among the diabetes subjects in the whole community decreased from9.3 ± 2.6% to 8.5 ± 2.4% within 1 year. Less than 5% of patients needed referral for further management to the tertiary diabetes hospital in Chennai.

Feedback of personal retinal images appears to have a motivational impact in people with non-proliferative diabetic retinopathy and suboptimal HbA1c: findings of a pilot study

AIM:
To conduct a pilot study to explore the potential impact of visual feedback of personal retinal images on diabetes outcomes.

METHODS:
Twenty-five participants with non-proliferative diabetic retinopathy and suboptimal HbA1c (> 53 mmol/mol; > 7%) were randomized to receive visual feedback of their own retinal images or to a control group. At baseline and 3-month follow-up, HbA1c, standard measures of beliefs, diabetes-related distress and self-care activities were assessed.

RESULTS:
In unadjusted models, relative to controls, the intervention group showed significantly greater improvement in HbA1c at 3-month follow-up (–0.6% vs. +0.3%, P < 0.01), as well as enhanced motivation to improve blood glucose management (P < 0.05).

CONCLUSIONS:
This small pilot study provides preliminary evidence that visual feedback of personal retinal images may offer a practical educational strategy for clinicians in eye care services to improve diabetes outcomes in non-target compliant patients. A fully powered randomized controlled trial is required to confirm these findings and determine the optimal use of feedback to produce sustained effects.

Disease burden evaluation of fall-related events in the elderly due to hypoglycemia and other diabetic complications: a clinical review

A hypoglycemia-induced fall is common in older persons with diabetes. The etiology of falls in this population is usually multifactorial, and includes microvascular and macrovascular complications and age-related comorbidities, with hypoglycemia being one of the major precipitating causes. In this review, we systematically searched the literature that was available up to March 31, 2014 from MEDLINE/PubMed, Embase, and Google Scholar using the following terms: hypoglycemia; insulin; diabetic complications; and falls in elderly. Hypoglycemia, defined as blood glucose <4.0 mmol/L (70 mg/dL) requiring external assistance, occurs in one-third of elderly diabetics on glucose-lowering therapies. It represents a major barrier to the treatment of diabetes, particularly in the elderly population. Patients who experience hypoglycemia are at a high risk for adverse outcomes, including falls leading to bone fracture, seizures, cognitive dysfunction, and prolonged hospital stays. An increase in mortality has been observed in patients who experience any one of these events. Paradoxically, rational insulin therapy, dosed according to a patient's clinical status and the results of home blood glucose monitoring, so as to achieve and maintain recommended glycemic goals, can be an effective method for the prevention of hypoglycemia and falls in the elderly. Contingencies, such as clinician-directed hypoglycemia treatment protocols that guide the immediate treatment of hypoglycemia, help to limit both the duration and severity of the event. Older diabetic patients with or without underlying renal insufficiency or other severe illnesses represent groups that are at high risk for hypoglycemia-induced falls and, therefore, require lower insulin dosages. In this review, the risk factors of falls associated with hypoglycemia in elderly diabetics were highlighted and management plans were suggested. A target hemoglobin A1c level between 7% and 8% seems to be more appropriate for this population. In addition, the first-choice drugs should have good safety profiles and have the lowest probability of causing hypoglycemia - such as metformin (in the absence of significant renal impairment) and incretin enhancers - while other therapies that may cause more frequent hypoglycemia should be avoided.

The association between dietary patterns, diabetes and depression.

Type 2 diabetes and depression are commonly comorbid high-prevalence chronic disorders. Diet is a key diabetes risk factor and recent research has highlighted the relevance of diet as a possible risk for factor common mental disorders. This study aimed to investigate the interrelationship among dietary patterns, diabetes and depression.

Diabetes mellitus e complicações em idosos residentes em municípios de médio porte no Estado de São Paulo

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Estudo das alterações estruturais e da função diastólica cardíaca em mulheres portadoras de diabetes melito gestacional

Pós-graduação em Ginecologia, Obstetrícia e Mastologia - FMB

The Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry

Background The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy. Methods A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients. Results The randomized cohort was 63.1 +/- 9.1 years old and 29% female, with a median diabetes duration of 10.2 +/- 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 +/- 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 +/- 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 +/- 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts. Conclusions The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD. (Am Heart J 2012;164:591-9.)

Metabolic Improvements in Obese Type 2 Diabetes Subjects Implanted for 1 Year with an Endoscopically Deployed Duodenal-Jejunal Bypass Liner

Background: The purpose of this study was to evaluate the effect of the duodenal-jejunal bypass liner (DJBL), a 60-cm, impermeable fluoropolymer liner anchored in the duodenum to create a duodenal-jejunal bypass, on metabolic parameters in obese subjects with type 2 diabetes. Methods: Twenty-two subjects (mean age, 46.2 +/- 10.5 years) with type 2 diabetes and a body mass index between 40 and 60 kg/m(2) (mean body mass index, 44.8 +/- 7.4 kg/m(2)) were enrolled in this 52-week, prospective, open-label clinical trial. Endoscopic device implantation was performed with the patient under general anesthesia, and the subjects were examined periodically during the next 52 weeks. Primary end points included changes in fasting blood glucose and insulin levels and changes in hemoglobin A1c (HbA1c). The DJBL was removed endoscopically at the end of the study. Results: Thirteen subjects completed the 52-week study, and the mean duration of the implant period for all subjects was 41.9 +/- 3.2 weeks. Reasons for early removal of the device included device migration (n = 3), gastrointestinal bleeding (n = 1), abdominal pain (n = 2), principal investigator request (n = 2), and discovery of an unrelated malignancy (n = 1). Using last observation carried forward, statistically significant reductions in fasting blood glucose (-30.3 +/- 10.2 mg/dL), fasting insulin (-7.3 +/- 2.6 mu U/mL), and HbA1c (-2.1 +/- 0.3%) were observed. At the end of the study, 16 of the 22 subjects had an HbA1c < 7% compared with only one of 22 at baseline. Upper abdominal pain (n = 11), back pain (n = 5), nausea (n = 7), and vomiting (n = 7) were the most common device-related adverse events. Conclusions: The DJBL improves glycemic status in obese subjects with diabetes and therefore represents a nonsurgical, reversible alternative to bariatric surgery.

Avaliação de resultados em um serviço de atenção secundária para pacientes com Diabetes mellitus

OBJETIVO: Avaliar o componente resultado em um serviço de atenção secundária a usuários com Diabetes mellitus tipo 2, tomando como indicadores os controles de pressão arterial, hemoglobina glicada e lipoproteína de baixa densidade. MÉTODOS: Estudo do tipo documental e retrospectivo envolvendo a análise desses indicadores, obtidos nos anos entre 2007 e 2009, com base na consulta de 108 prontuários de usuários de um serviço de atenção secundária, realizada na avaliação de cuidados em saúde. RESULTADOS: Os resultados evidenciaram que 30,3% dos usuários alcançaram a meta para a hemoglobina glicada, 48,1%, para a pressão arterial e 42,3%, para a lipoproteína de baixa densidade. CONCLUSÃO: Os dados avaliados foram semelhantes aos encontrados em outras investigações internacionais e nacionais, com grande proporção de usuários com DM2 estudados, apresentando controle dos níveis hemoglobina A1c, PA e LDL-C, aquém do preconizado nos consensos.

Evidence-based clinical use of insulin premixtures

Brazil is expected to have 19.6 million patients with diabetes by the year 2030. A key concept in the treatment of type 2 diabetes mellitus (T2DM) is establishing individualized glycemic goals based on each patient’s clinical characteristics, which impact the choice of antihyperglycemic therapy. Targets for glycemic control, including fasting blood glucose, postprandial blood glucose, and glycated hemoglobin (A1C), are often not reached solely with antihyperglycemic therapy, and insulin therapy is often required. Basal insulin is considered an initial strategy; however, premixed insulins are convenient and are equally or more effective, especially for patients who require both basal and prandial control but desire a more simplified strategy involving fewer daily injections than a basal-bolus regimen. Most physicians are reluctant to transition patients to insulin treatment due to inappropriate assumptions and insufficient information. We conducted a nonsystematic review in PubMed and identified the most relevant and recently published articles that compared the use of premixed insulin versus basal insulin analogues used alone or in combination with rapid-acting insulin analogues before meals in patients with T2DM. These studies suggest that premixed insulin analogues are equally or more effective in reducing A1C compared to basal insulin analogues alone in spite of the small increase in the risk of nonsevere hypoglycemic events and nonclinically significant weight gain. Premixed insulin analogues can be used in insulin-naïve patients, in patients already on basal insulin therapy, and those using basal-bolus therapy who are noncompliant with blood glucose self-monitoring and titration of multiple insulin doses. We additionally provide practical aspects related to titration for the specific premixed insulin analogue formulations commercially available in Brazil.