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Showing papers in "Diabetic Medicine in 2016"


Journal ArticleDOI
TL;DR: This study investigates whether the effects of diabetes‐associated complications can explain the apparent relationship between diabetic foot ulcers and death.
Abstract: Aims The presence of diabetic foot ulcers is strongly associated with an increased risk of death. In this study, we investigate whether the effects of diabetes-associated complications can explain the apparent relationship between diabetic foot ulcers and death. Methods We analysed data from 414 523 people with diabetes enrolled in practices associated with The Health Improvement Network in the United Kingdom. Our methods were designed to control for potential confounders in order to isolate the relationship between diabetic foot ulcers and death. Using proportional hazards models and the area under the receiver operator curve, we evaluated the effects of diabetic foot ulcers and the covariates on death. Results Among the patients, 20 737 developed diabetic foot ulcers; 5.0% of people with new ulcers died within 12 months of their first foot ulcer visit and 42.2% of people with foot ulcers died within 5 years. After controlling for major known complications of diabetes that might influence mortality, the correlation between diabetic foot ulcers and death remained strong with a fully adjusted hazard ratio of 2.48 (95% confidence interval: 2.43, 2.54). Geographic variance existed but was not spatially associated. Conclusions Diabetic foot ulcers are linked to an increased risk of death. This cannot be explained by other common risk factors. These results suggest that either there are major unknown risk factors associated with both diabetic foot ulcers and death, or that diabetic foot ulceration itself is a serious threat, which seems unlikely. A diabetic foot ulcer should be seen as a major warning sign for mortality, necessitating closer medical follow-up.

291 citations


Journal ArticleDOI
TL;DR: To assess whether diabetes increases the risk of carpal tunnel syndrome and to estimate the magnitude of the association with Type 1 and Type 2 diabetes, a large number of patients with a history of type 1 or 2 diabetes are surveyed.
Abstract: Aims To assess whether diabetes increases the risk of carpal tunnel syndrome and to estimate the magnitude of the association with Type 1 and Type 2 diabetes. Methods We conducted a systematic search of PubMed, Embase, Web of Science, Scopus, Google Scholar and ResearchGate for articles published between 1950 and January 2015. A total of 36 studies (eight cross-sectional, 21 case–control and seven cohort studies) qualified for meta-analysis. We used a random-effects meta-analysis and assessed heterogeneity and publication bias. Results The pooled odds ratio of 25 studies (including a total of 92 564 individuals) that reported unadjusted estimates for the association between diabetes and carpal tunnel syndrome or carpal tunnel release was 1.97 (95% CI 1.56–2.49). The pooled odds ratio of 18 case–control or cohort studies consisting of >37 million individuals that reported estimates after controlling for potential confounders was 1.69 (95% CI 1.45–1.96). The association did not differ for Type 1 and Type 2 diabetes. Furthermore, there was no publication bias. Conclusion This meta-analysis suggests that both Type 1 and Type 2 diabetes are risk factors for carpal tunnel syndrome.

108 citations


Journal ArticleDOI
TL;DR: To compare the properties of the two most commonly used assessment tools for diabetes distress, the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS), in order to discriminate their psychometric capabilities and functions.
Abstract: Aims To compare the properties of the two most commonly used assessment tools for diabetes distress, the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS), in order to discriminate their psychometric capabilities and functions. Methods Six hundred and twenty-eight people with diabetes (67% Type 1, 33% Type 2) were cross-sectionally assessed with the PAID, the DDS and further self-report scales regarding coping, quality of life, depressive symptoms and self-care, and medical data were gained. We analysed the PAID and DDS for areas of contentual/psychometric divergence in assessing diabetes distress and compared their associations with criteria of interest. Results Content analysis: The PAID covers a greater variety of emotional concerns and shows a stronger focus on food-related problems and complications. The DDS is more reflective of physician-related distress and problems concerning diabetes self-management. Psychometric analysis: Exploratory factor analyses revealed four-factor structures of both scales, explaining 60% (PAID) and 67% (DDS) of variance. Confirmatory factor analyses confirmed that single-factor and four-factor models fit the data. Total scales proved high and subscales mostly satisfactory reliability. Associations with criteria of interest: The PAID was significantly more strongly associated with dysfunctional coping styles, quality of life and depressive symptoms. The DDS showed significantly stronger associations with diabetes self-care and metabolic outcomes. Conclusion Our results support both PAID and DDS as good self-report measures of diabetes distress. The observed contentual/psychometric differences suggest that a justified choice with regard to the intended clinical or scientific purpose can improve the acquisition of the required data.

105 citations


Journal ArticleDOI
TL;DR: To estimate potential cost avoidance through modest and achievable improvements in glycaemic control in adults with Type 1 or Type 2 diabetes mellitus in the UK healthcare system, a large number of patients will have had diabetes at some point in their lives.
Abstract: Aim To estimate potential cost avoidance through modest and achievable improvements in glycaemic control in adults with Type 1 or Type 2 diabetes mellitus in the UK healthcare system. Methods The IMS Core Diabetes Model was used to examine the impact of improved glycaemic control (indicated by reduction in HbA1c level), in a representative cohort of adults with Type 1 or Type 2 diabetes. The cumulative incidence of microvascular and macrovascular complications was modelled across 5-year periods to a 25-year time horizon. Complication costs were applied to the data to estimate potential accrued cost avoidance. Results Significant cost avoidance of ~£340 m is apparent in the first 5 years, increasing to ~£5.5bn after 25 years of sustained improvement in control. The overwhelming majority of cost avoidance arises from reductions in microvascular complications. In people with Type 1 diabetes the greatest cost avoidance comes from a reduction in renal disease (74% of cost avoidance), while in people with Type 2 diabetes it is generated by a reduction in foot ulcers, amputations and neuropathy: 57% cost avoidance). Greater cost reduction is accrued more rapidly in people with higher starting HbA1c levels. Conclusion Modest improvements in glycaemic control generate significant reductions in the incidence and, therefore, cost of microvascular complications in people with Type 1 or Type 2 diabetes. This study provides clear support for the premise that prioritized and sustained investment in early and better intervention can provide concrete financial benefits in both the short and longer term.

104 citations


Journal ArticleDOI
TL;DR: Using data from nationwide examination surveys of German adults, data on temporal changes in the prevalence of diagnosed diabetes, as well as undiagnosed diabetes and prediabetes, have been lacking in Germany as in most other European countries.
Abstract: Aims Nationally representative data on temporal changes in the prevalence of diagnosed diabetes, as well as undiagnosed diabetes and prediabetes, have been lacking in Germany as in most other European countries. We aimed to fill this gap using data from nationwide examination surveys of German adults. Methods The study population comprised 18-79-year-old participants from the German Health Interview and Examination Surveys in 1997-1999 (GNHIES98, n = 6655) and 2008-2011 (DEGS1, n = 7017). Participants were classified as having diagnosed diabetes based on self-reported physician-diagnosed diabetes or the use of anti-diabetes agents. Among those without diagnosed diabetes, HbA1c measures were used to define undiagnosed diabetes [≥ 48 mmol/mol (≥ 6.5%)] or prediabetes [39-47 mmol/mol (5.7-6.4%)]. Results Although the age- and sex-standardized prevalence of total diabetes remained stable between 1997-1999 at 9.3% (95% CI 8.3-10.5%) and 2008-2011 at 9.2% (8.3-10.3%), the prevalence of diagnosed diabetes increased from 5.6% (4.9-6.3%) to 7.2% (6.5-8.0%), whereas the prevalence of undiagnosed diabetes decreased from 3.8% (3.1-4.6%) to 2.0% (1.5-2.7%), resulting in a decreased proportion of undiagnosed diabetes (40.9% vs. 21.7%). Over the same period, the prevalence of prediabetes decreased from 27.7% (25.6-29.8%) to 20.8% (18.2-23.7%). Observed temporal changes were not explained by changes in BMI, sport activity and educational level. Conclusions The two nationwide surveys indicate a shift from undiagnosed to diagnosed diabetes. However, the unchanged prevalence of total diabetes and the considerably high proportion of prediabetes strongly call for a continued and concerted effort in diabetes prevention among German adults.

103 citations


Journal ArticleDOI
TL;DR: The aim of this study was to explore the association of OCT1 reduced‐function polymorphisms with common metformin‐induced gastrointestinal side effects in Type 2 diabetes.
Abstract: Metformin is the most widely used oral anti-diabetes agent and has considerable benefits over other therapies, yet 20-30% of people develop gastrointestinal side effects, and 5% are unable to tolerate metformin due to the severity of these side effects. The mechanism for gastrointestinal side effects and their considerable inter-individual variability is unclear. We have recently shown the association between organic cation transporter 1 (OCT1) variants and severe intolerance to metformin in people with Type 2 diabetes. The aim of this study was to explore the association of OCT1 reduced-function polymorphisms with common metformin-induced gastrointestinal side effects in Type 2 diabetes.This prospective observational cohort study included 92 patients with newly diagnosed Type 2 diabetes, incident users of metformin. Patients were genotyped for two common loss-of-function variants in the OCT1 gene (SLC22A1): R61C (rs12208357) and M420del (rs72552763). The association of OCT1 reduced-function alleles with gastrointestinal side effects was analysed using logistic regression.Forty-three patients (47%) experienced gastrointestinal adverse effects in the first 6 months of metformin treatment. Interestingly, the number of OCT1 reduced-function alleles was significantly associated with over two-fold higher odds of the common metformin-induced gastrointestinal side effects (odds ratio = 2.31, 95% confidence interval 1.07-5.01, P = 0.034).In conclusion, we showed for the first time the association between OCT1 variants and common metformin-induced gastrointestinal side effects. These results confirm recent findings related to the role of OCT1 in severe metformin intolerance, and suggest that high inter-individual variability in mild/moderate and severe gastrointestinal intolerance share a common underlying mechanism. These data could contribute to more personalized and safer metformin treatment.

97 citations


Journal ArticleDOI
TL;DR: To evaluate treatment options for neuropathic pain and sensory symptoms resulting from diabetic peripheral neuropathy of the feet, a clinical trial is conducted at the University of Michigan.
Abstract: Aim To evaluate treatment options for neuropathic pain and sensory symptoms resulting from diabetic peripheral neuropathy of the feet. Methods The databases PubMed, Embase and Web-of-Science were searched for randomized controlled trials, published in the period from database inception to 2 July 2015, that evaluated treatments for diabetic peripheral neuropathy of the feet with placebo or standard treatment as comparators. Participants in these trials included people with diabetes mellitus and diabetic peripheral neuropathy who were given any treatment for diabetic peripheral neuropathy. Risk of bias was assessed using the Delphi list of criteria. Data from the trials were extracted using standardized data extraction sheets by two authors independently. All analyses were performed using RevMan 5.2. In case of clinical homogeneity, statistical pooling was performed using a random effects model. Results This review included 27 trials on pharmacological, non-pharmacological and alternative treatments. In the meta-analysis of trials of α-lipoic acid versus placebo, total symptom score was reduced by -2.45 (95% CI -4.52; -0.39) with 600 mg i.v. α-lipoic acid (three trials), and was reduced by -1.95 (95% CI -2.89; -1.01) with 600 mg oral α-lipoic acid (two trials). Significant improvements in diabetic peripheral neuropathy symptoms were found with opioids, botulinum toxin A, mexidol, reflexology and Thai foot massage, but not with micronutrients, neurotrophic peptide ORG 2677 and photon stimulation therapy. Conclusion In this review, we found that α-lipoic acid, opioids, botulinum toxin A, mexidol, reflexology and Thai foot massage had significant beneficial results.

93 citations


Journal ArticleDOI
TL;DR: To evaluate the effect of vitamin D on insulin resistance and glycaemic control in prediabetes, a large number of animals were tested and it was found that animals that receive vitamin D during the summer are more prone to develop diabetes.
Abstract: Aims To evaluate the effect of vitamin D on insulin resistance and glycaemic control in prediabetes. Methods A literature search was conducted of MEDLINE, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Web of Science and www.clinicaltrials.gov, together with a historical search through the reference lists of relevant articles until end of June 2014. Studies were included if they were randomized controlled trials of vitamin D or vitamin D analogues in prediabetes and if they reported homeostatic model assessment of insulin resistance or 2-h plasma glucose after oral glucose tolerance test. Treatment effect was estimated according to mean difference in the changes from baseline of homeostatic model assessment of insulin resistance, 2-h oral glucose tolerance test plasma glucose, fasting plasma glucose and HbA1c between vitamin D and control groups. Meta-analysis of eligible studies was performed. Results A total of 10 randomized controlled trials were included. Vitamin D did not significantly improve homeostatic model assessment of insulin resistance and 2-h oral glucose tolerance test plasma glucose: the mean differences were -0.06 (95% CI -0.36 to 0.24) and -0.23 mmol/l (95% CI -0.65 to 0.19), respectively. Subgroup analysis suggested that vitamin D improved homeostatic model assessment of insulin resistance in a subgroup with baseline 25-hydroxyvitamin D ≥ 50 nmol/l [mean difference -0.59 (95% CI -1.14 to -0.04); P = 0.03] and improved 2-h oral glucose tolerance test plasma glucose in the subgroup with baseline 25-hydroxyvitamin D < 50 nmol/l [mean difference -0.68 mmol/l (95% CI -1.35 to -0.01); P = 0.05]. Vitamin D significantly reduced fasting plasma glucose and HbA1c levels. The mean differences were -0.10 mmol/l (95% CI -0.18 to -0.03), P = 0.006 and -1 mmol/mol (95% CI -2 to 0), P = 0.008, respectively. Conclusions No beneficial effect of vitamin D in improving insulin resistance was identified.

91 citations


Journal ArticleDOI
TL;DR: To assess the effect of prediabetes (impaired fasting glucose and/or impaired glucose tolerance) on the incidence of chronic kidney disease, a large number of patients with atypical fasting glucose levels and a high glucose tolerance are enrolled.
Abstract: To assess the effect of prediabetes (impaired fasting glucose and/or impaired glucose tolerance) on the incidence of chronic kidney disease. PubMed and EMBASE were searched (for studies published up to March 2015). Effects estimated from cohort studies reporting the relationship of prediabetes to incident chronic kidney disease [kidney damage (microalbuminuria, albuminuria or proteinuria) and/or decreased glomerular filtration rate] were pooled using a random-effects model meta-analysis. Nine cohort studies with a total of 185 452, mainly Asian and white, participants were followed for a total of 835 146 person-years. In eight cohort studies defining impaired fasting glucose as fasting glucose 6.1-6.9 mmol/l, the summary relative risk of chronic kidney disease after adjustment for established risk factors was 1.11 (95% CI 1.02-1.21). When a study defining impaired fasting glucose as fasting glucose 5.6-6.9 mmol/dl was added, the overall relative risk of chronic kidney disease was 1.12 (95% CI 1.02-1.21). Exclusion of the only study with information on impaired glucose tolerance did not change the relative risk (1.12; 95% CI 1.02-1.21). There was no evidence of publication bias (P value for Egger test = 0.12). Prediabetes is modestly associated with an increase in chronic kidney disease risk, but this remains to be robustly confirmed. Chronic kidney disease screening among people with prediabetes, and aggressive management of prediabetes in those with chronic kidney disease may be warranted. This article is protected by copyright. All rights reserved.

87 citations


Journal ArticleDOI
TL;DR: To examine, in a national survey, the outcomes of adult patients presenting with DKA in 2014, mapped against accepted UK national guidance.
Abstract: AIM: To examine, in a national survey, the outcomes of adult patients presenting with DKA in 2014, mapped against accepted UK national guidance. METHODS: Data were collected in a standardized form covering clinical and biochemical outcomes, risk and discharge planning. The form was sent to all UK diabetes specialist teams (n = 220). Anonymized data were collected on five consecutive patients admitted with DKA between 1 May 2014 and 30 November 2014. RESULTS: A total of 283 forms were received (n = 281 patients) from 72 hospitals, of which 71.4% used the national guidelines. The results showed that 7.8% of cases occurred in existing inpatients, 6.1% of admissions were newly diagnosed diabetes and 33.7% of patients had had at least one episode of DKA in the preceding year. The median times to starting 0.9% sodium chloride and intravenous insulin were 41.5 and 60 min, respectively. The median time to resolution was 18.7 h and the median length of hospital stay was 2.6 days. Significant adverse biochemical outcomes occurred, with 27.6% of patients developing hypoglycaemia and 55% reported as having hypokalaemia. There were also significant issues with care processes. Initial nurse-led observations were carried out well, but subsequent patient monitoring remained suboptimal. Most patients were not seen by a member of the diabetes specialist team during the first 6 h, but 95% were seen before discharge. A significant minority of discharge letters to primary care did not contain necessary information. CONCLUSION: Despite widespread adoption of national guidance, several areas of management of DKA are suboptimal, being associated with avoidable biochemical and clinical risk.

80 citations


Journal ArticleDOI
TL;DR: The efficacy of low‐carbohydrate diets in people with Type 2 diabetes has divided the nutrition community and this review seeks to re‐examine the available data to clarify understanding.
Abstract: Aims The efficacy of low-carbohydrate diets (LCD) in people with Type 2 diabetes has divided the nutrition community. This review seeks to re-examine the available data to clarify understanding. Methods A comprehensive search of databases was used to identify meta-analyses of LCD in Type 2 diabetes. To improve the quality of the studies analysed, the following inclusion criteria were applied: randomized control trials ≥ 4 weeks in people aged > 18 years with Type 2 diabetes; a carbohydrate intake ≤ 45% of total energy intake per day; and a dietary intake assessment at the end of the study. The resulting studies were subjected to a thematic analysis. Results Nine meta-analyses were identified containing 153 studies. Twelve studies met our amended inclusion criteria. There were no significant differences in metabolic markers, including glycaemic control, between the two diets, although weight loss with a LCD was greater in one study. Carbohydrate intake at 1 year in very LCD (< 50 g of carbohydrates) ranged from 132 to 162 g. In some studies, the difference between diets was as little as 8 g/day of carbohydrates. Conclusion Total energy intake remains the dietary predictor of body weight. A LCD appears no different from a high-carbohydrate diet in terms of metabolic markers and glycaemic control. Very LCDs may not be sustainable over a medium to longer term as carbohydrate intake in diets within studies often converged toward a more moderate level. The variable quality of studies included in earlier meta-analyses likely explains the previous inconsistent findings between meta-analyses.

Journal ArticleDOI
TL;DR: An updated perspective of interventions from additional data collected since the first review, conducted in 2008, is given.
Abstract: Aims To give an updated perspective of interventions from additional data collected since our first review, conducted in 2008. Background This updated Cochrane Review incorporates new information from recent randomized controlled trials on culturally appropriate diabetes health education interventions. Methods An electronic literature search of six databases was repeated, with databases of ongoing trials checked and three journals hand-searched. Meta-analysis was carried out for sufficiently homogeneous outcomes, and common themes among trials were highlighted. Results A total of 22 new trials were added to the original 11. Meta-analysis of 28 trials containing suitable data showed significant improvements in glycaemic control (HbA1c) and diabetes knowledge over a period of 24 months, after the delivery of culturally appropriate education to participants, compared with those receiving ‘conventional’ care. There were no consistent benefits over the control group in other selected outcome measures, and lack of data continued to make analysis of several outcome measures difficult. Conclusions Research activity in this field has increased considerably over the past 6 years, with culturally appropriate diabetes education showing consistent benefits over conventional care in terms of glycaemic control and diabetes knowledge, sustained in the short- to mid-term. Further research is needed to determine the clinical significance of these improvements and their cost-effectiveness.

Journal ArticleDOI
TL;DR: To determine the effects of protein alone (independent of fat and carbohydrate) on postprandial glycaemia in individuals with Type 1 diabetes mellitus using intensive insulin therapy, protein alone is used as a biomarker.
Abstract: Aim To determine the effects of protein alone (independent of fat and carbohydrate) on postprandial glycaemia in individuals with Type 1 diabetes mellitus using intensive insulin therapy. Methods Participants with Type 1 diabetes mellitus aged 7–40 years consumed six 150 ml whey isolate protein drinks [0 g (control), 12.5, 25, 50, 75 and 100] and two 150 ml glucose drinks (10 and 20 g) without insulin, in randomized order over 8 days, 4 h after the evening meal. Continuous glucose monitoring was used to assess postprandial glycaemia. Results Data were collected from 27 participants. Protein loads of 12.5 and 50 g did not result in significant postprandial glycaemic excursions compared with control (water) throughout the 300 min study period (P > 0.05). Protein loads of 75 and 100 g resulted in lower glycaemic excursions than control in the 60–120 min postprandial interval, but higher excursions in the 180–300 min interval. In comparison with 20 g glucose, the large protein loads resulted in significantly delayed and sustained glucose excursions, commencing at 180 min and continuing to 5 h. Conclusions Seventy-five grams or more of protein alone significantly increases postprandial glycaemia from 3 to 5 h in people with Type 1 diabetes mellitus using intensive insulin therapy. The glycaemic profiles resulting from high protein loads differ significantly from the excursion from glucose in terms of time to peak glucose and duration of the glycaemic excursion. This research supports recommendations for insulin dosing for large amounts of protein.

Journal ArticleDOI
TL;DR: A large number of Muslims with diabetes reside within the UK and the holy month of Ramadan poses many potential risks for those with diabetes who wish to observe Ramadan.
Abstract: Background Globally there are approximately 90 million Muslims with diabetes of which approximately 400 000 reside within the UK. The holy month of Ramadan is a fundamental practice of this religion of which fasting from sun-rise to sun-set is an integral part. This poses many potential risks for those with diabetes who wish to observe Ramadan. Methods The evidence base for best clinical management of Type 1 and Type 2 diabetes during Ramadan was reviewed. We reviewed current and previous recommendations for safe fasting during Ramadan. Results The risks associated with fasting in those with diabetes and preparing your patient for Ramadan are discussed. We have reviewed the evidence around diet-controlled diabetes and therapies including; metformin, acarbose, metglitinides, sulfonylureas, thiazolidinidiones, dipeptidyl peptidase-4 inhibitor (DPP-4), sodium glucose co-transporter -2 (SGLT-2) inhibitors, glucagon-like peptide -1 (GLP-1) receptor agonists and insulin. Conclusion Up to date guidelines for the management of treatment regimes are set-out for those with Type 1 and Type 2 diabetes who wish to fast during Ramadan.

Journal ArticleDOI
TL;DR: The objective was to examine the association between food insecurity, diabetes self‐care and glycaemic control.
Abstract: Aims Food insecurity is the ‘limited or uncertain availability of nutritionally adequate and safe foods’. Our objective was to examine the association between food insecurity, diabetes self-care and glycaemic control. Methods We conducted a cross-sectional analysis of baseline data from adult patients with Type 2 diabetes who were enrolled in a randomized trial evaluating a health literacy-focused diabetes intervention in safety net primary care clinics in middle Tennessee. Food insecurity was assessed with three items from the U.S. Household Food Security Survey. Diabetes self-care behaviours were assessed with the Summary of Diabetes Self-Care Activities Scale, Personal Diabetes Questionnaire and Adherence to Refills and Medication Scale. Glycaemic control was assessed with HbA1c. Results The sample consisted of 401 participants, 73% of whom reported some level of food insecurity. Food insecurity was significantly associated with self-care behaviours including less adherence to a general diet [Adjusted Odds Ratio (AOR) 0.9, P = 0.02], less physical activity (AOR 0.9, P = 0.04) and with a greater occurrence of medication non-adherence (AOR 1.2, P = 0.002) and calorie restriction (AOR 1.1, P = 0.02). Food insecurity was also associated with worse glycaemic control (adjusted β = 0.1, P = 0.03). None of the self-care behaviours were significantly associated with HbA1c, limiting the ability to test for self-care as a mechanism linking food insecurity to glycaemic control. Conclusions There was a high rate of food insecurity in a sample of patients with Type 2 diabetes who were of low socio-economic status. Food insecurity was associated with less adherence to recommended self-care behaviours and worse glycaemic control.

Journal ArticleDOI
TL;DR: To provide comprehensive real‐world evidence on societal diabetes‐attributable costs in Denmark, a database of diabetes-related deaths and hospitalisations in Denmark is compiled.
Abstract: Aim To provide comprehensive real-world evidence on societal diabetes-attributable costs in Denmark. Methods National register data are linked on an individual level through unique central personal registration numbers in Denmark. All patients in the Danish National Diabetes Register in 2011 (N = 318 729) were included in this study. Complication status was defined according to data from the Danish National Hospital Register. Diabetes-attributable costs were calculated as the difference between costs of patients with diabetes and the expected costs given the annual resource consumption of the diabetes-free population. Results Societal costs attributable to diabetes were estimated to be at least 4.27 billion EUR in 2011, corresponding to 14,349 EUR per patient-year. A twofold higher healthcare resource usage was found for patients with diabetes as compared with the diabetes-free population. Attributable costs, grouped according to different components, were 732 million EUR for primary and secondary care services, 153 million EUR for pharmaceutical drugs, 851 million EUR for nursing services, 1.77 billion EUR in lost productivity and 761 million EUR for additional costs. A steep increase in diabetes-attributable costs was found for patients with major complications compared with patients without complications across all cost components. For attributable healthcare costs this increase was estimated to be 6,992 EUR per person-year after controlling for potential confounders. Conclusions Nearly half of the total costs of patients with diabetes can be attributed directly to their diabetes. The majority of costs are incurred among patients with major complications pointing to the importance of secondary preventive efforts among patients with diabetes.

Journal ArticleDOI
TL;DR: To assess the impact of interventions promoting the monitoring of medication use and brief messaging to support medication adherence in patients with Type 2 diabetes mellitus, and to investigate the extent of theory use to guide intervention development.
Abstract: © 2016 Diabetes UK. Aims: To assess the impact of interventions promoting the monitoring of medication use and brief messaging to support medication adherence in patients with Type 2 diabetes mellitus, and to investigate the extent of theory use to guide intervention development. Methods: We systematically searched for controlled trials, published from 1990 onwards in Medline, Embase, CINAHL, PsycINFO and the Cochrane library, that evaluated interventions based on monitoring and brief messaging to support medication adherence in patients with Type 2 diabetes, to examine the effectiveness of such interventions. Results: A total of 11 trials, comparing 15 interventions, were identified. Only a small minority presented a low risk of bias. Three interventions were based on delivering brief messages, six were based on monitoring medication adherence, and six used both strategies. Messaging interventions included the use of short message service text messages, web-based feedback, and messages delivered through monitoring devices. Monitoring interventions included remote self-reporting of medication and telephone calls with healthcare staff. Improvements in medication adherence were observed in six interventions, although effect sizes were generally moderate. Only two interventions improved both adherence and clinical outcomes. A meta-analysis of five trials (eight interventions) combining monitoring and messaging strategies showed that the pooled difference in medication adherence between intervention and control was moderate and not statistically significant [standardized mean difference = 0.22 (95% CI -0.05; 0.49)]. Only four trials were based on explicit theoretical frameworks. Conclusions: Although interventions based on messaging and monitoring have the potential to improve medication adherence in patients with Type 2 diabetes, evidence of their efficacy is limited and additional high-quality, theory-based research is needed.

Journal ArticleDOI
TL;DR: To determine if women with diabetes in pregnancy have a delayed onset of lactation through a systematic review of the literature, a large number of studies have found that it is possible.
Abstract: Aim To determine if women with diabetes in pregnancy have a delayed onset of lactation through a systematic review of the literature. Methods We searched databases including MEDLINE, Web of Science, PubMed, CINAHL Plus and PsychINFO for articles assessing diabetes in pregnancy and lactogenesis. Thirty-one articles were screened and 10 articles were included in the systematic review. We extracted data on diabetes in pregnancy and onset of lactation (secretory activation or lactogenesis II). Results The 10 studies examining the association between women with diabetes in pregnancy and delayed onset of lactation reported a significant delay in women with diabetes compared with women without diabetes. Two studies assessed the impact of metabolic control on lactogenesis, and found an association between poorer metabolic control and delayed onset of lactation. Conclusions Although this review has found evidence of an association between women experiencing diabetes during pregnancy and delayed onset of lactation, the presence of many potential confounding factors need to be acknowledged.

Journal ArticleDOI
TL;DR: To determine the prevalence of depression and diabetes distress in adults with Type 1 diabetes and the rate of false‐positives when compared with rates of major depressive disorder, a large number of subjects were surveyed.
Abstract: Aims To determine the prevalence of depression and diabetes distress in adults with Type 1 diabetes and the rate of false-positives when compared with rates of major depressive disorder. Methods The sample consisted of 368 individuals with Type 1 diabetes, aged > 19 years. Individuals completed: the eight-item Patient Health Questionnaire depression scale (PHQ8), which was coded using four scoring criteria (scores > 10, >12 and >15, and Diagnostic and Statistical Manual of Mental Disorders 5 (DSM) algorithm scores); the Type 1 Diabetes Distress Scale; and the Structured Clinical Interview for DSM Disorders (SCID) to assess major depressive disorder. Results The prevalence rates of depression according to the eight-item Patient Health Questionnaire were: score >10, 11.4%; score >12, 7.1%; score >15, 3.8%; and positive algorithm result, 4.6%. The prevalence of major depressive disorder was 3.5%; and the prevalence of at least moderate diabetes distress was 42.1%. Depending on the criterion used, the false-positive rate when using the Patient Health Questionnaire compared with the results when using the SCID varied from 52 to 71%. Of those classified as depressed on the PHQ-8 or Structured Clinical Interview for DSM Disorders, between 92.3 and 96.2% also reported elevated diabetes distress. No significant association was found between any group classed as having depression according to the PHQ8 or the SCID and HbA1c concentration. Depression was significantly associated with more other life stress, more complications and a lower level of education. Conclusions We found an unexpectedly low rate of current depression and major depressive disorder in this diverse sample of adults with Type 1 diabetes, and a very high rate of false-positive results using the Patient Health Questionnaire. Considering the high prevalence of diabetes distress, much of what has been considered depression in adults with Type 1 diabetes may be attributed to the emotional distress associated with managing a demanding chronic disease and other life stressors and not necessarily to underlying psychopathology.

Journal ArticleDOI
TL;DR: The aim of this study was to determine the natural progression and clinical management of HNF1A–MODY diabetes in a dedicated MODY clinic.
Abstract: Aims HNF1A gene mutations are the most common cause of maturity-onset diabetes of the young (MODY) in the UK. Persons with HNF1A–MODY display sensitivity to sulphonylurea therapy; however, the long-term efficacy is not established. There is limited literature as to the prevalence of micro- and macrovascular complications in this unique cohort. The aim of this study was to determine the natural progression and clinical management of HNF1A–MODY diabetes in a dedicated MODY clinic. Methods Sixty patients with HNF1A–MODY and a cohort of 60 BMI-, age-, ethnicity- and diabetes duration-matched patients with Type 1 diabetes mellitus participated in the study. All patients were phenotyped in detail. Clinical follow-up of the HNF1A–MODY cohort occurred on a bi-annual basis. Results Following a genetic diagnosis of MODY, the majority of the cohort treated with sulphonylurea therapy remained insulin independent at 84–month follow-up (80%). The HbA1c in the HNF1A–MODY group treated with sulphonylurea therapy alone improved significantly over the study period [from 49 (44–63) mmol/mol, 6.6 (6.2–7.9)% to 41 (31–50) mmol/mol, 5.9 (5–6.7)%; P = 0.003]. The rate of retinopathy was significantly lower than that noted in the Type 1 diabetes mellitus group (13.6 vs. 50%; P = 0.0001).There was also a lower rate of microalbuminuria and cardiovascular disease in the HNF1A–MODY group compared with the Type 1 diabetes mellitus group. Conclusions This study demonstrates that the majority of patients with HNF1A–MODY can be maintained successfully on sulphonylurea therapy with good glycaemic control. We note a significantly lower rate of micro- and macrovascular complications than reported previously. The use of appropriate therapy at early stages of the disorder may decrease the incidence of complications.

Journal ArticleDOI
TL;DR: To assess resource utilization associated with severe hypoglycaemia across three insulin regimens in a large phase 3a clinical programme involving people with Type 1 diabetes treated with basal–bolus insulin, people with types 1 and 2 treated with multiple daily injections and people with type 2 diabetes treatedwith basal–oral therapy.
Abstract: Aims To assess resource utilization associated with severe hypoglycaemia across three insulin regimens in a large phase 3a clinical programme involving people with Type 1 diabetes treated with basal–bolus insulin, people with Type 2 diabetes treated with multiple daily injections and people with Type 2 diabetes treated with basal–oral therapy. Methods Data relating to severe hypoglycaemia events (defined as episodes requiring external assistance) from the insulin degludec and insulin degludec/insulin aspart programme (15 trials) were analysed using descriptive statistics. Comparators included insulin glargine, biphasic insulin aspart, insulin detemir and sitagliptin. Mealtime insulin aspart was used in some regimens. This analysis used the serious adverse events records, which documented the use of ambulance/emergency teams, a hospital/emergency room visit ≤ 24 h, or a hospital visit > 24 h. Results In total, 536 severe hypoglycaemia events were analysed, of which 157 (29.3%) involved an ambulance/emergency team, 64 (11.9%) led to hospital/emergency room attendance of ≤ 24 h and 36 (6.7%) required hospital admission (> 24 h). Although there were fewer events in people with Type 2 diabetes compared with Type 1 diabetes, once a severe episode occurred, the tendency to utilize healthcare resources was higher in Type 2 diabetes vs. Type 1 diabetes. A higher proportion (47.6%) in the basal–oral therapy group required hospital treatment for > 24 h versus the Type 1 diabetes (5.0%) and Type 2 diabetes multiple daily injections (5.3%) groups. Conclusion This analysis suggests that severe hypoglycaemia events often result in emergency/ambulance calls and hospital treatment, incurring a substantial health economic burden, and were associated with all insulin regimens.

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TL;DR: To estimate the healthcare costs attributable to diabetes in Ontario, Canada using a propensity‐matched control design and health administrative data from the perspective of a single‐payer healthcare system, it is suggested that the number of uninsured people in Ontario is higher than in the United States.
Abstract: Aims To estimate the healthcare costs attributable to diabetes in Ontario, Canada using a propensity-matched control design and health administrative data from the perspective of a single-payer healthcare system. Methods Incident diabetes cases among adults in Ontario were identified from the Ontario Diabetes Database between 2004 and 2012 and matched 1:3 to control subjects without diabetes identified in health administrative databases on the basis of sociodemographics and propensity score. Using a comprehensive source of administrative databases, direct per-person costs (Canadian dollars 2012) were calculated. A cost analysis was performed to calculate the attributable costs of diabetes; i.e. the difference of costs between patients with diabetes and control subjects without diabetes. Results The study sample included 699 042 incident diabetes cases. The costs attributable to diabetes were greatest in the year after diagnosis [C$3,785 (95% CI 3708, 3862) per person for women and C$3,826 (95% CI 3751, 3901) for men], increasing substantially for older age groups and patients who died during follow-up. After accounting for baseline comorbidities, attributable costs were primarily incurred through inpatient acute hospitalizations, physician visits and prescription medications and assistive devices. Conclusions The excess healthcare costs attributable to diabetes are substantial and pose a significant clinical and public health challenge. This burden is an important consideration for decision-makers, particularly given increasing concern over the sustainability of the healthcare system, aging population structure and increasing prevalence of diabetic risk factors, such as obesity.

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TL;DR: Genome‐wide approaches and the potential of other ‘omics’, including metagenomics and metabolomics, are outlined, highlighting the complex interacting networks that the authors need to understand before they can truly personalize diabetes treatments.
Abstract: Personalized medicine, otherwise called stratified or precision medicine, aims to better target intervention to the individual to maximize benefit and minimize harm. This review discusses how diabetes aetiology, pathophysiology and patient genotype influence response to or side effects of the commonly used diabetes treatments. C-peptide is a useful biomarker that is underused to guide treatment choice, severe insulin deficiency predicts non-response to glucagon-like peptide-1 receptor agonists, and thiazolidinediones are more effective in insulin-resistant patients. The field of pharmacogenetics is now yielding clinically important results, with three examples outlined: sulphonylurea sensitivity in patients with HNF1A maturity-onset diabetes of the young; sulphonylurea sensitivity in patients with Type 2 diabetes with reduced function alleles at CYP2C9, resulting in reduced metabolism of sulphonylureas; and severe metformin intolerance associated with reduced function organic cation transporter 1 (OCT1) variants, exacerbated by drugs that also inhibit OCT1. Genome-wide approaches and the potential of other 'omics', including metagenomics and metabolomics, are then outlined, highlighting the complex interacting networks that we need to understand before we can truly personalize diabetes treatments.

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TL;DR: To explore barriers to and motivators for physical activity in a group of overweight and obese individuals with dysregulated Type 2 diabetes, a large number of them are overweight or obese.
Abstract: Aim To explore barriers to and motivators for physical activity in a group of overweight and obese individuals with dysregulated Type 2 diabetes. Methods Data were collected from the Steno Diabetes Center's outpatient clinic in Denmark. Four focus groups were conducted including 28 individuals with Type 2 diabetes aged 39–71 years. The facilitators used open-ended questions and probes such as images, statements and quotations about physical activity to foster active participation and interaction among participants. Focus groups were recorded on video and the discussions were transcribed and analysed thematically. Results We identified four main themes: 1) the body as a barrier to physical activity because of functional limitations; 2) logistical challenges, including lack of time and awareness of where to exercise in the local area; 3) being physically active with others, providing a sense of mutual commitment and enjoyment; and 4) goal-setting and self-tracking, which was seen as an opportunity to track physical improvement over time. Conclusions The findings suggest that, once people are active, a high level of social interaction may help maintain their activity levels. Further research is needed to investigate the effect of combining individually tailored exercise plans with the establishment of customized and locally based exercise communities that offer enjoyment and support. Additionally, it is relevant to explore experiences of using self-tracking technologies to review short- and long-term goals.

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TL;DR: To review and evaluate the most recent literature on the economic outcomes of pharmacist‐managed services in people with diabetes, a large number of patients with diabetes are receiving pharmacist-managed services.
Abstract: Aim To review and evaluate the most recent literature on the economic outcomes of pharmacist-managed services in people with diabetes. Background The global prevalence of diabetes is increasing. Although pharmacist-managed services have been shown to improve people's health outcomes, the economic impact of these programmes remains unclear. Methods A systematic review was conducted of six databases. Study inclusion criteria were: (1) original research; (2) evaluation of pharmacist-managed services in people with diabetes; (3) an economic evaluation; (4) English-language publication; and (5) full-text, published between January 2006 and December 2014. The quality of the full economic evaluations reviewed was evaluated using the Consolidated Health Economic Evaluation Reporting Standards checklist. Results A total of 2204 articles were screened and 25 studies were selected. These studies were conducted in a community pharmacy (n = 10), a clinic- /hospital-based outpatient facility (n = 8), or others. Pharmacist-managed services included targeted education (n = 24), general pharmacotherapeutic monitoring (n = 21), health screening or laboratory testing services (n = 9), immunization services (n = 2) and pharmacokinetic monitoring (n = 1). Compared with usual care, pharmacist-managed services resulted in cost savings that varied from $7 to $65,000 ($8 to $85,000 in 2014 US dollars) per person per year, and generated higher quality-adjusted life years with lower costs. Benefit-to-cost ratios ranged from 1:1 to 8.5:1. Among the 25 studies reviewed, 11 were full economic evaluations of moderate quality. Conclusions Pharmacist-managed services had a positive return in terms of economic viability. With the expanding role of pharmacists in the healthcare sector, alongside increasing health expenditure, future economic studies of high quality are needed to investigate the cost-effectiveness of these services.

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TL;DR: The aim of this study was to determine the combined effect of obesity and low muscle strength, dynapenia, on the risk of incident Type 2 diabetes in older adults.
Abstract: Aim Obesity is a well-established risk factor for developing Type 2 diabetes. Evidence suggests that sarcopenia, the age-related decline in muscle mass and strength, may exacerbate diabetes risk in obese individuals. The aim of this study was to determine the combined effect of obesity and low muscle strength, dynapenia, on the risk of incident Type 2 diabetes in older adults. Methods Participants were 5953 (1670 obese) men and women from the English Longitudinal Study of Ageing without known Type 2 diabetes at baseline and for whom handgrip strength, biochemical and other clinical data were collected. A diagnosis of Type 2 diabetes was recorded from self-reported physician diagnosis over 6 years. Results For each unit increase in grip strength, there was a reduction in diabetes risk (age-, sex- and BMI adjusted HR; 0.98; 95% CI 0.96–0.99). The risk of Type 2 diabetes was elevated in all obese participants, but was greatest in those with low handgrip strength (HR = 4.93, 95% CI 2.85, 8.53) compared with non-obese individuals with high handgrip strength. Eleven per cent of the sample met the threshold for weakness (handgrip strength: men < 26 kg; women < 16 kg) that was associated with elevated Type 2 diabetes risk in obese (HR = 3.57, 95% CI 2.04, 6.24) but not in non-obese (HR = 0.86, 95% CI, 0.44, 1.68) compared with normal/non-obese participants. Conclusion Dynapenic obesity, determined by high BMI and low handgrip strength, is associated with increased risk of incident Type 2 diabetes in older people.

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TL;DR: The relationship between 1‐ and 2‐h glucose levels following an oral glucose tolerance test (OGTT) and long‐term mortality was evaluated.
Abstract: Aims The relationship between 1- and 2-h glucose levels following an oral glucose tolerance test (OGTT) and long-term mortality was evaluated. Methods Over a 33-year period, 2138 individuals were followed for all-cause mortality. Fasting and post-OGTT glucose parameters categorized the cohort according to baseline glycaemic status. Four categories were established according to 1- and 2-h glucose levels (in mmol/l): group A = 1 h ≤ 8.8 and 2 h 8.6 and 2 h 8.6 and 2 h = 7.8–11.1 (impaired glucose tolerance). Individuals with diabetes at baseline were excluded from the cohort. Results By August 2013, 51% of the study cohort had died. The worst prognosis occurred in group D (73.8% mortality), followed by groups C (67.5%), B and A (57.9% and 41.6%, respectively). When the 2-h glucose value is ‘normal’ ( 8.6 mmol/l is an important predictor of mortality (28% increased risk) compared with group A, controlling for sex, age, smoking, BMI, systolic and diastolic blood pressures. A gradual increased hazard for mortality was seen by study group (hazard ratio = 1.28, 1.60 and 1.76, for groups B, C and D, respectively; group A = reference). Conclusions A 1-h glucose value > 8.6 mmol/l predicts mortality even when the 2-h level is < 7.8 mmol/l. However, when the 2-h level is in the impaired glucose tolerance range, the hazard for mortality rises significantly independent of the 1-h value. Individuals at risk for developing diabetes could be identified earlier using the 1-h threshold value of 8.6 mmol/l, which could avert progression to diabetes and increased mortality.‬

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TL;DR: To conduct a systematic review and meta‐analysis of epidemiological studies in order to assess quantitatively the effect of dairy consumption on risk of metabolic syndrome.
Abstract: Aims To conduct a systematic review and meta-analysis of epidemiological studies in order to assess quantitatively the effect of dairy consumption on risk of metabolic syndrome. Methods We searched for eligible studies published up to March 2015 through the PubMed and Embase databases and reviewed the references of relevant articles. Random-effects models were used to calculate the pooled relative risks with 95% CIs after adjusting for several confounders. Results We identified nine prospective cohort studies including a total of 35 379 subjects and 7322 incident cases of metabolic syndrome, and 12 cross-sectional studies including 37 706 subjects. In the meta-analysis of prospective cohort studies, the pooled relative risk of incidence of metabolic syndrome for the highest vs. the lowest category of dairy consumption was 0.85 (95% CI 0.73–0.98), and for a 1-serving/day increment of dairy consumption, the pooled relative risk was 0.88 (95% CI 0.82–0.95). In the meta-analysis of cross-sectional studies, the pooled relative risk of prevalence of metabolic syndrome for the highest vs. the lowest category of dairy consumption was 0.73 (95% CI 0.63–0.86). The association was not significantly different by geographical region, follow-up time and adjustment factors. Conclusion Our findings indicate that dairy consumption is inversely associated with the incidence and prevalence of metabolic syndrome. Further well-designed cohort studies and randomized controlled trials are warranted to provide definitive evidence.

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TL;DR: Key elements of shared decision‐making are presented and three different approaches for its application are proposed, which focus on transferring information to patients so that they can make decisions, and cultivating the individual's ability to give voice to which choice is best for them.
Abstract: People with diabetes often live with other chronic conditions and lead complicated lives. Determining what is the best management decision for a patient requires consideration of each individual's personal, social and biomedical context, what he or she values, the reasons he or she has to value the available options, and the relative contribution of each option in terms of benefits, harms, costs and inconveniences. Empathic conversations between patients and clinicians to diagnose the patient situation that necessitates action and the range of evidence-based actions that best address the situation, so-called shared decision-making, are essential to the personalized care of people with diabetes. The aim of the present review was to present key elements of shared decision-making and propose three different approaches for its application. The first approach focuses on transferring information to patients so that they can make decisions. The second approach, choice, focuses on cultivating the individual's ability to give voice to which choice is best for them. The third approach, conversation, establishes an empathic conversational environment through which the individual with diabetes and their clinician think and talk through how to address the problems of living with diabetes and related illnesses. These approaches are manifest in the design of evidence-based decision aids created to support shared decision-making. In randomized trials, decision aids can efficiently improve patient's knowledge, satisfaction, risk awareness, decisional conflict and involvement. Further research, however, is needed to better understand when and how to promote the empathic conversations, patient, clinician and service and policy contexts necessary to routinely implement shared decision-making in different at scale healthcare systems. In the interim, sufficient evidence and tools exist for persons with diabetes and their clinicians to gain expertise in making decisions together.

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TL;DR: To investigate the prevalence of diagnosed Type 2 diabetes and its related complications in a nationally representative sample of older adults in the Republic of Ireland, a cohort study of over-65s was conducted.
Abstract: Aim To investigate the prevalence of diagnosed Type 2 diabetes and its related complications in a nationally representative sample of older adults in the Republic of Ireland. Methods Cross-sectional analysis of a population-based sample of adults aged ≥ 50 years from the first wave of The Irish Longitudinal Study on Ageing (TILDA), (2009–2011). Diagnosed Type 2 diabetes prevalence was estimated by self-report or the use of oral hypoglycaemic agents. The prevalence of microvascular and macrovascular complications was determined by self-report. Results Diagnosed Type 2 diabetes prevalence was 8.4% [95% confidence interval (CI): 7.8–9.0%] and was higher among men [10.3% (95% CI: 9.4–11.2%)] than women [6.6% (95% CI: 5.9–7.5%)]; P ≤ 0.001. Among participants with diagnosed Type 2 diabetes, the overall prevalence of microvascular complications was 26.0% (95% CI: 22.4–30.0%) with no evidence of gender-specific differences (P = 0.7). The overall prevalence of macrovascular complications was 15.1% (95% CI: 12.2–18.4%) and was higher among men [17.8% (95% CI: 14.3–23.1%)] than women [11.4% (95% CI: 7.7–16.4%)]; P ≤ 0.001. Conclusions In the absence of a national diabetes register, these findings provide a robust estimate of the national prevalence of diagnosed Type 2 diabetes and level of complications among adults aged 50 years and over in Ireland.