Diabetes Clinical Outcomes Research Articles

Biomarkers of cardiovascular disease: contributions to risk prediction in individuals with diabetes.

Cardiovascular disease is a leading cause of death, especially in individuals with diabetes mellitus, whose risk of morbidity and mortality due to cardiovascular disease is markedly increased compared with the general population. There has been growing interest in the identification of biomarkers of cardiovascular disease in people with diabetes. The present review focuses on the current and potential contributions of these biomarkers to predicting cardiovascular risk in individuals with diabetes. At present, certain biomarkers and biomarker combinations can lead to modest improvements in the prediction of cardiovascular disease in diabetes beyond traditional cardiovascular risk factors. Emerging technologies may enable the discovery of novel biomarkers and generate new information about known biomarkers (such as new combinations of biomarkers), which could lead to significant improvements in cardiovascular disease risk prediction. A critical question, however, is whether improvements in risk prediction will affect processes of care and decision making in clinical practice, as this will be required to achieve the ultimate goal of improving clinical outcomes in diabetes.

Investigating the behavioural effects of a mobile-phone based home telehealth intervention in people with insulin-requiring diabetes: Results of a randomized controlled trial with patient interviews

Introduction Evidence supporting home telehealth effects on clinical outcomes in diabetes is available, yet mechanisms of action for these improvements remain poorly understood. Behavioural change is one plausible explanation. This study investigated the behavioural effects of a mobile-phone based home telehealth (MTH) intervention in people with diabetes. It was hypothesized that MTH would improve self-efficacy, illness beliefs, and diabetes self-care. Methods A randomized controlled trial compared standard care to standard care supplemented with MTH (self-monitoring, data transmission, graphical and nurse-initiated feedback, educational calls). Self-report measures of self-efficacy, illness beliefs, and self-care were repeated at baseline, three months, and nine months. MTH effects were based on the group by time interactions in hierarchical linear models and effect sizes with 95% confidence intervals (CIs). Interviews with MTH participants explored the perceived effects of MTH on diabetes self-management. Results Eighty-one participants were randomized to the intervention (n = 45) and standard care (n = 36). Significant group by time effects were observed for five out of seven self-efficacy subscales. Effect sizes were large, particularly at nine months. Interaction effects for illness beliefs and self-care were non-significant, but effect sizes and confidence intervals suggested MTH may positively affect diet and exercise. In interviews, MTH was associated with increased awareness, motivation, and a greater sense of security. Improved self-monitoring and diet were reported by some participants. Discussion MTH empowers people with diabetes to manage their condition and may influence self-care. Future MTH research would benefit from investigating behavioural mechanisms and determining patient profiles predictive of greater behavioural effectiveness.

PDB88 - Examining a threshold of adherence to oral hypoglycemic agents relevant to clinical outcomes in diabetes: A tree-structured survival model

PDB88 - Examining a threshold of adherence to oral hypoglycemic agents relevant to clinical outcomes in diabetes: A tree-structured survival model

Using Health Information Technology to Prevent and Treat Diabetes

Using Health Information Technology to Prevent and Treat Diabetes

Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with Diabetes

BackgroundGiven the increasing prevalence of diabetes and the lack of patients reaching recommended therapeutic goals, novel models of team-based care are emerging. These teams typically include a combination of physicians, nurses, case managers, pharmacists, and community-based peer health promoters (HPs). Recent evidence supports the role of pharmacists in diabetes management to improve glycemic control, as they offer expertise in medication management with the ability to collaboratively intensify therapy. However, few studies of pharmacy-based models of care have focused on low income, minority populations that are most in need of intervention. Alternatively, HP interventions have focused largely upon low income minority groups, addressing their unique psychosocial and environmental challenges in diabetes self-care. This study will evaluate the impact of HPs as a complement to pharmacist management in a randomized controlled trial.Methods/DesignThe primary aim of this randomized trial is to evaluate the effectiveness of clinical pharmacists and HPs on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels. A total of 300 minority patients with uncontrolled diabetes from the University of Illinois Medical Center ambulatory network in Chicago will be randomized to either pharmacist management alone, or pharmacist management plus HP support. After one year, the pharmacist-only group will be intensified by the addition of HP support and maintenance will be assessed by phasing out HP support from the pharmacist plus HP group (crossover design). Outcomes will be evaluated at baseline, 6, 12, and 24 months. In addition, program and healthcare utilization data will be incorporated into cost and cost-effectiveness evaluations of pharmacist management with and without HP support.DiscussionThe study will evaluate an innovative, integrated approach to chronic disease management in minorities with poorly controlled diabetes. The approach is comprised of clinic-based pharmacists and community-based health promoters collaborating together. They will target patient-level factors (e.g., lack of adherence to lifestyle modification and medications) and provider-level factors (e.g., clinical inertia) that contribute to poor clinical outcomes in diabetes. Importantly, the study design and analytic approach will help determine the differential and combined impact of adherence to lifestyle changes, medication, and intensification on clinical outcomes.Trial registrationClinicalTrials.gov identifier: NCT01498159

Use of outcomes in monitoring healthcare – how many outcome measures are needed in monitoring diabetes in primary care?

To investigate the relationship between patient experience assessed through surveys of random samples of practice populations and intermediate outcome targets in those patients with diabetes, collected in the Quality and Outcomes Framework pay-for-performance scheme. Cross-sectional study. The East Midlands region of England. Six hundred and twenty-nine general practices. Logistic regression models were used to assess whether practice-level reports of patient experience of access and consultations were associated with achievement of treatment targets (HbA1c of 7.5% and 10% or lower, BP 145/85 mmHg or lower, and cholesterol 5 mmol/L or lower) in people with diabetes. Survey respondent characteristics (ethnicity, age, sex) and practice size, deprivation, and prevalence of diabetes and obesity were also assessed within the models. Patient experience of practice populations explained little of the variation in diabetes treatment targets. In the practice survey, the proportion of respondents who had seen a nurse in the last 6 months was associated with increased likelihood of achieving HbA1c of 7.5%, and being involved in decision-making or having tests and treatment explained were associated with achievement of HbA1c of 10% or less, cholesterol of 5 mmol/L or less, and BP of 145/85 or less. Although patient experience at practice level should be included in monitoring outcomes, it should not replace monitoring clinical outcomes in diabetes. A mix of clinical and patient experience measures will have to be used to monitor outcomes in general practice.

The dissociation between the diabetes and both Child–Pugh score and in-hospital mortality in cirrhotic patients due to hepatitis B, hepatitis C, or alcoholic

Up to 30% of the cirrhotic patients may clinically be classified as having diabetes. The aims of this retrospective study were to evaluate the prevalence of diabetes, its association with the severity of cirrhosis, and subsequent implication on mortality in a broad population of cirrhotic patients in Taiwan. From January 2004 to October 2008, 4,127 cirrhotic patients were reviewed. The latest demographic data were gathered after the latest laboratory measurement in the outpatient or inpatient department. In all, 2,945 patients were included on the basis of the etiology of cirrhosis: hepatitis B, hepatitis C, hepatitis B, and hepatitis C co-infection, or alcoholics. The observed cases of diabetes were significantly higher in cirrhotic patients than general population. Neither the Child-Pugh score (odds ratio=0.99, p=0.527) nor the model for end-stage liver disease score (MELD) (odds ratio=1.00, p=0.352) was associated with diabetes. The presence of diabetes was dissociated with renal function by means of serum creatinine (β=-0.01, p=0.604) or estimated glomerular filtration rate (eGFR) (β=-0.02, p=0.233), or in-hospital mortality (odds ratio=1.08, p=0.362). The prevalence of diabetes was higher in cirrhotic patients in Taiwan. The prevalence of diabetes was dissociated with Child-Pugh or MELD score. The diagnosis of diabetes did not affect the renal function or in-hospital mortality in cirrhotic patients. Since the clinical outcomes of diabetes were different from cirrhotic patients to general population, it is unclear whether the treatment of diabetes and improved glycemic control will benefit cirrhotic patients.

AS-256: Triple versus Dual Antiplatelet Therapy in Chronic Stable Angina Patients with Diabetes Undergoing Elective Percutaneous Coronary Intervention with Drug-Eluting Stents

Adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) is known to reduce restenosis and is associated with favorable clinical outcomes in diabetes. However, there is limited data related to the use of triple antiplatelet therapy in chronic stable angina patients with diabetes in real-world clinical practice.

Obesity and intermediate clinical outcomes in diabetes: evidence of a differential relationship across ethnic groups

To examine associations between obesity, ethnicity and intermediate clinical outcomes in diabetes. Population-based, cross-sectional study using electronic primary care medical records of 7300 people with diabetes from White, Black and south Asian ethnic groups. The pattern of obesity differed within ethnic groups, with rates significantly higher in younger when compared to older Black (women, 63% vs. 44%, P = 0.002; men, 37% vs. 20%, P = 0.005) and south Asian (women, 47% vs. 27%, P = 0.01; men, 21% vs. 13%, P = 0.05) people. Obese people with diabetes were significantly less likely to achieve an established target for blood pressure control (adjusted odds ratio 0.50, 95% confidence interval 0.42, 0.59). Differences in mean systolic blood pressure in obese and normal weight persons were significant in the White group but not in the Black groups or south Asian groups (6.9 mmHg, 1.9 mmHg and 2.7 mmHg, respectively). Differences in mean diastolic blood pressure between obese and normal weight persons were 4.8 mmHg, 3.6 mmHg and 3.4 mmHg in the White, Black and south Asian groups. Mean HbA(1c) and achievement of an established treatment target did not differ significantly with obesity in any ethnic group. Obesity is more prevalent amongst younger people than older people with diabetes in ethnic minority groups. The relationship between obesity and blood pressure control in diabetes differs markedly across ethnic groups. Major efforts must be implemented, especially in young people, to reduce levels of obesity in diabetes and improve long-term outcomes.

History of major depressive disorder and diabetes outcomes in diet‐ and tablet‐treated post‐menopausal women: a case control study

Little is known about the long-term associations between remitted major depressive disorder (MDD) and clinical diabetes outcomes. This study investigated associations between a remote history of fully remitted MDD and (i) glycaemic control, (ii) diabetes symptoms, and (iii) physical and emotional functioning in post-menopausal women with Type 2 diabetes (T2DM). Forty-four post-menopausal women with diet- or tablet-treated T2DM participated. Twenty-three had never experienced depression and 21 had a history of MDD. All participants had been free of MDD and antidepressant treatment for > or = 1 year. Compared with their never-depressed counterparts, women with a history of MDD had significantly higher HbA(1c) (7.0 vs. 6.5%), more diabetes symptoms, and worse emotional functioning, after controlling for confounding variables. Differences in HbA(1c) and diabetes symptoms were not accounted for by the higher current subclinical depressive symptoms observed in the previously depressed group. Differences in emotional functioning were accounted for by current subclinical depressive symptoms. Most health-care providers overlook fully remitted depression. However, previously depressed patients, who outnumber currently depressed patients, may still have poorer glycaemic control than never-depressed patients.

Use of herbal remedies by diabetic Hispanic women in The southwestern United States

The primary purpose of this study was to examine the use and documentation of herbal remedies used by Hispanic women with Type II diabetes enrolled in two Community Health Centers in the Southwest USA. A secondary purpose was to review the literature on identified herbs to assess their likely effects on diabetes. Open-ended structured interviews were conducted on a convenience sample (n = 23) of participants. Medical and medication charts were reviewed for the interviewed participants, and for a random sample of enrolled Hispanic diabetic patients (n = 81) who were not interviewed. Two Community Health Centers in the Southwest USA. Enrolled patient, Hispanic females with Type II diabetes. Subjects were interviewed about their use of herbal therapies and supplements. Information collected from medical and pharmaceutical charts included documented use of herbal remedies; standard therapies prescribed and diabetes control (hemoglobin A1C values). For those herbal remedies reported, literature reviews were conducted to determine if there was supporting evidence of harm or efficacy for the stated condition. Reports of herbal use, and types of remedies used. Among the interviewed participants, 21 of 23 (91%) reported using one or more herbal remedies. Among a random sample of patient medical charts, seven (6.7%) contained documentation of diabetes-specific herbs, and 16 (15.4%) had documented general herb use. A total of 77 different herbal remedies were identified, most of which were contained as part of commercial preparations, and appeared to supplement, rather than replace standard medical therapy for diabetes. Use of herbal therapies is not uncommon among diabetic patients. Many of the herbs reported have potential efficacy in treating diabetes or may result in adverse effects or interactions. In practical use, however, the herbs reported in this study are unlikely to have a significant effect on clinical outcomes in diabetes, either positively or negatively.

Improving Diabetes Care by Combating Clinical Inertia

Over the last 10 years, numerous clinical trials have provided consistent and strong evidence that adequate control of glycated hemoglobin (HbA1c), blood pressure (BP), and LDL-cholesterol (LDL) levels significantly reduces major macrovascular complications (Pyorala et al. 1997; Hansson et al. 1998), microvascular complications (U.K. Prospective Diabetes Study [UKPDS] Group 1998), and mortality in adults with type 2 diabetes mellitus. Clinical strategies that simultaneously control HbA1c, BP, and LDL may yield multiplicative benefits. For example, in one multifactorial diabetes clinical trial, simultaneous intensification of care across multiple clinical domains reduced major cardiovascular events by 50 percent over an 8-year period (Gaede et al. 2003). Epidemiological data further underscore the dominance of HbA1c, BP, and LDL as predictors of significant clinical outcomes in diabetes. About 70 percent of adults with diabetes die from a heart attack or stroke (Haffner et al. 1998). Significantly fewer die of renal failure or experience blindness over the course of their diabetes (NDDG 1995). Thus, both epidemiological studies and clinical trials strongly support the hypothesis that interventions to control HbA1c, BP, and LDL have the greatest potential to extend life and sustain quality of life for adults with type 2 diabetes. In light of this persuasive evidence, it is curious that many national diabetes care quality measures continue to emphasize preventive processes of care, rather than assessing HbA1c, BP, and LDL levels. For example, from 1994 to 1999 the principal HEDIS measure of diabetes care quality was the rate of eye exams. It was not until 2000 that HEDIS expanded its diabetes measures to include HbA1c and LDL levels. In 2005, the HEDIS comprehensive diabetes measure still do not include BP control, but continue to include measures of eye exams and nephropathy screening (HEDIS 1995, 2000, 2005). While early detection of eye and kidney problems is not unimportant, it is possible that continued emphasis on screening for these factors may have the unintended consequence of diverting resources and attention from the clinically more productive tasks of achieving and maintaining better control of HbA1c, BP, and LDL levels (Marshall et al. 2000; Sperl-Hillen et al. 2000; Hofer, Zemencuk, and Hayward 2004).

Diabetic patient education: determinants of success.

Education/empowerment is critical if successful self-management is to be achieved. All professional patient interactions have a learning component. Clinical outcomes in diabetes are as dependent on psycho-social factors or learned behaviour as on metabolic state or therapeutic interventions. These factors include targets set, self-management skills, influence of living with diabetes, emotional factors, role of other people, perceived benefits and barriers, feelings of self-efficacy, weight concern and diet barrier. Training in learning processes and factors governing behaviour are essential for all those involved in delivery of patient care. Educational programmes should recognise the wide range of learning strategies used by different people.