Clinical Use and Effectiveness of Lipid Lowering Therapies in Diabetes Mellitus—An Observational Study from the Swedish National Diabetes Register

OBJECTIVES: To describe the use and evaluate the effectiveness of different lipid lowering therapies in unselected patients with type 1 and type 2 diabetes in clinical practice. DESIGN: Observational population-based study using the personal identification number to link information from the National Diabetes Register, the Prescribed Drug Register and the Patient register in Sweden. All patients in the NDR aged 18-75 years with diabetes more than one year were eligible, but only patients starting any lipid lowering treatment with at least three prescriptions 1 July 2006-30 June 2007 were included (n = 37,182). The mean blood lipid levels in 2008 and reductions in LDL cholesterol were examined. RESULTS: Blood lipid levels were similar in patients treated with simvastatin, atorvastatin and rosuvastatin, showing similar lipid lowering effect as currently used. Users of pravastatin, fluvastatin, ezetimib and fibrate more seldom reach treatment goals. Moderate daily doses of the statins were used, with 76% of simvastatin users taking 20 mg or less, 48% of atorvastatin users taking 10 mg, 55% of pravastatin users taking 20 mg, and 76% of rosuvastatin users taking 5 or 10 mg. CONCLUSIONS: This observational study shows that the LDL-C levels in patients taking simvastatin, atorvastatin or rosuvastatin are very similar as currently used, as well as their LDL-C lowering abilities. There is potential to intensify lipid lowering treatment to reduce the remaining high residual risk and achieve better fulfilment of treatment goals, since the commonly used doses are only low to moderate

Severe COVID-19 in people with type 1 and type 2 diabetes in Sweden: a nationwide retrospective cohort study

Background: Whether infection with SARS-CoV-2 leads to excess risk of requiring hospitalization or intensive care in persons with diabetes has not been reported, nor have risk factors in diabetes associated with increased risk for these outcomes. Methods: We included 44,639 and 411,976 adult patients with type 1 and type 2 diabetes alive on Jan 1, 2020, and compared them to controls matched for age, sex, and county of residence (n=204,919 and 1,948,900). Age- and sex-standardized rates for COVID-19 related hospitalizations, admissions to intensive care and death, were estimated and hazard ratios were calculated using Cox regression analyses. Findings: There were 10,486 hospitalizations and 1,416 admissions into intensive care. A total of 1,175 patients with diabetes and 1,820 matched controls died from COVID-19, of these 53•2% had been hospitalized and 10•7% had been in intensive care. Patients with type 2 diabetes, compared to controls, displayed an age- and sex-adjusted hazard ratio (HR) of 2•22, 95%CI 2•13-2•32) of being hospitalized for COVID-19, which decreased to HR 1•40, 95%CI 1•34-1•47) after further adjustment for sociodemographic factors, pharmacological treatment and comorbidities, had higher risk for admission to ICU due to COVID-19 (age- and sex-adjusted HR 2•49, 95%CI 2•22-2•79, decreasing to 1•42, 95%CI 1•25-1•62 after adjustment, and increased risk for death due to COVID-19 (age- and sex-adjusted HR 2•19, 95%CI 2•03-2•36, complete adjustment 1•50, 95%CI 1•39-1•63). Age- and sex-adjusted HR for COVID-19 hospitalization for type 1 diabetes was 2•10, 95%CI 1•72-2•57), decreasing to 1•25, 95%CI 0•3097-1•62) after adjustment• Patients with diabetes type 1 were twice as likely to require intensive care for COVID-19, however, not after adjustment (HR 1•49, 95%CI 0•75-2•92), and more likely to die (HR 2•90, 95% CI 1•6554-5•47) from COVID-19, but not independently of other factors (HR 1•38, 95% CI 0•64-2•99). Among patients with diabetes, elevated glycated hemoglobin levels were associated with higher risk for most outcomes. Interpretation: In this nationwide study, type 2 diabetes was independently associated with increased risk of hospitalization, admission to intensive care and death for COVID-19. There were few admissions into intensive care and deaths in type 1 diabetes, and although hazards were significantly raised for all three outcomes, there was no independent risk persisting after adjustment for confounding factors

HbA1C and Cancer Risk in Patients with Type 2 Diabetes – A Nationwide Population-Based Prospective Cohort Study in Sweden

Background: Diabetes is associated with increased cancer risk. The underlying mechanisms remain unclear. Hyperglycemia might be one risk factor. HbA1c is an indicator of the blood glucose level over the latest 1 to 3 months. This study aimed to investigate association between HbA1c level and cancer risks in patients with type 2 diabetes based on real life situations. Methods: This is a cohort study on 25,476 patients with type 2 diabetes registered in the Swedish National Diabetes Register from 1997-1999 and followed until 2009. Follow-up for cancer was accomplished through register linkage. We calculated incidences of and hazard ratios (HR) for cancer in groups categorized by HbA1c <= 58 mmol/mol (7.5%) versus >58 mmol/mol, by quartiles of HbA1c, and by HbA1c continuously at Cox regression, with covariance adjustment for age, sex, diabetes duration, smoking and insulin treatment, or adjusting with a propensity score. Results: Comparing HbA1c >58 mmol/mol with <= 58 mmol/mol, adjusted HR for all cancer was 1.02 [95% CI 0.95-1.10] using baseline HbA1c, and 1.04 [95% CI 0.97-1.12] using updated mean HbA1c, and HRs were all non-significant for specific cancers of gastrointestinal, kidney and urinary organs, respiratory organs, female genital organs, breast or prostate. Similarly, no increased risks of all cancer or the specific types of cancer were found with higher quartiles of baseline or updated mean HbA1c, compared to the lowest quartile. HR for all cancer was 1.01 [0.98-1.04] per 1%-unit increase in HbA1c used as a continuous variable, with non-significant HRs also for the specific types of cancer per unit increase in HbA1c. Conclusions: In this study there were no associations between HbA1c and risks for all cancers or specific types of cancer in patients with type 2 diabetes

Cardiovaskular risk factors and complications in type 1 and type 2 diabetes

Patients with diabetes have increased risk of cardiovascular disease (CVD) and mortality compared to the general population. The aim of this work was to describe the clinical characteristics and risk factors in patients with type 1 diabetes, and also to investigate the association between glycaemic control and CVD in type 1 and type 2 diabetes, and to analyse the association between BMI, overweight and obesity, and CVD in type 2 diabetes. These observational studies comprise patients from the Swedish National Diabetes Register (NDR). Clinical characteristics and risk factor control in type 1 diabetes were analysed in two cross-sectional samples, in 1997 and 2004. 7454 patients with type 1 diabetes were followed from 2002/03 to 2007, and 13,087 patients (Study III) and 18,336 (Study IV) with type 2 diabetes were followed from 1997/98 to 2003, regarding fatal/non-fatal CVD events. Cox proportional hazard models were used to estimate adjusted hazard ratios with 95% confidence intervals and to estimate 5- and 6-year event rates for the outcomes. In patients with type 1 diabetes slight but significant improvements were seen in glycaemic control, blood pressure and lipid levels from 1997 to 2004. Hazard ratios for coronary heart disease (CHD) and CVD per 1%-unit increase in baseline HbA1c were 1.31 and 1.26 (p<0.001), respectively, when adjusted for age, sex, duration of diabetes and cardiovascular risk factors. Adjusted 5-year event rates of CHD and CVD increased progressively with higher HbA1c levels. Patients with HbA1c levels of 5-7.9% (mean 7.2%) at baseline had about 40% lower risk for CHD and CVD, compared with patients with HbA1c 8-11.9% (mean 9.0%). In type 2 diabetes adjusted hazard ratios for a 5-unit increase in BMI were 1.15 for first-incident CHD and 1.13 for CVD. Obesity was associated with a 44% increase in risk of CVD, and overweight with a 24% increase in risk, compared with normal weight. Adjusted hazard ratios for a 1%-unit increase in HbA1c were 1.11 for CHD and 1.10 for CVD (p<0.001), and the corresponding adjusted 6-year event rates for these outcomes increased progressively with higher baseline and updated mean HbA1c values, also when sub-grouping the data by duration, previous CVD or hypoglycaemic treatment. A group of patients with a mean baseline HbA1c of 6.5% showed a 20% lower risk of CHD and a 16% lower risk of CVD, than a group with a mean HbA1c of 7.5%. These large observational studies on patients with diabetes in everyday clinical practice show a slow improvement in glycaemic control and risk factors in type 1 diabetes. Higher HbA1c level was found to be independently associated with increased risk of CHD and CVD, emphasizing the role of HbA1c as a strong independent risk factor in type 1 diabetes. In type 2 diabetes, increasing risks of CHD and CVD were seen in patients with higher HbA1c levels, while no risk increase was seen in those with low HbA1c levels. HbA1c levels lower than 7% were associated with a lower risk of CVD, providing support for current treatment guidelines. Higher BMI, overweight and obesity independently increased the risk of CHD and CVD in patients with type 2 diabetes, providing additional evidence that overweight and obesity should be counteracted in type 2 diabetes

Risk trajectories of complications in over one thousand newly diagnosed individuals with type 2 diabetes

Abstract Although the increased risk of complications of type 2 diabetes (T2D) is well known, there is still little information about the long-term development of comorbidities in relation to risk factors. The purpose of the present study was to describe the risk trajectories of T2D complications over time in an observational cohort of newly diagnosed T2D patients, as well as to evaluate the effect of common risk factors on the development of comorbidities. This national cohort study investigated individuals with T2D in the Swedish National Diabetes Register regarding prevalence of comorbidities at the time of diagnosis, and the incidence of cardiovascular disease (CVD), chronic kidney disease (CKD) and heart failure in the entire patient cohort and stratified by HbA1c levels and age at baseline. Multivariable Cox regressions were used to evaluate risk factors predicting outcomes. We included 100,878 individuals newly diagnosed with T2D between 1998 and 2012 in the study, with mean 5.5 years follow-up (max 17 years). The mean age at diagnosis was 62.6 ± SD12.5 years and 42.7% of the patients were women. Prevalent CVD was reported for 17.5% at baseline. Although the prevalence of comorbidities was generally low for individuals 50 years or younger at diagnosis, the cumulative incidence of the investigated comorbidities increased over time. Newly diagnosed CVD was the most common comorbidity. Women were shown to have a lower risk of developing comorbid conditions than men. When following the risk trajectory of comorbidities over a period of up to 15 years in individuals with type 2 diabetes, we found that all comorbidities gradually increased over time. There was no distinct time point when onset suddenly increased

Patients' and health care professionals' perceptions of the potential of using the digital Diabetes Questionnaire to prepare for diabetes care meetings : Qualitative focus group interview study

BACKGROUND: In effective diabetes management, it is important that providers and health care systems prioritize the delivery of patient-centered care and that they are respectful of and responsive to individual patient preferences and barriers. OBJECTIVE: The objective of the study was to conduct focus group interviews to capture patients' and health care professionals' perceptions and attitudes regarding digital technology and to explore how the digital Diabetes Questionnaire can be used to support patient participation in diabetes care, as a basis for an implementation study. METHODS: A qualitative study was conducted with six focus group discussions with diabetes specialist nurses and medical doctors (n=29) and four focus group discussions with individuals with diabetes (n=23). A semistructured focus group interview guide was developed, including probing questions. The data were transcribed verbatim, and qualitative content analysis was performed using an inductive approach. RESULTS: Two main categories were revealed by the qualitative analysis: perceptions of digital technology and the digital questionnaire in diabetes management and care and perceptions of participation in diabetes care. An overarching theme that emerged from the focus group interviews was patients' and professionals' involvement in diabetes care using digital tools. CONCLUSIONS: The analysis identified important factors to consider when introducing the digital Diabetes Questionnaire in clinical use. Both professionals and patients need support and training in the practical implementation of the digital questionnaire, as well as the opportunity to provide feedback on the questionnaire answers

Glycemic and risk factor control in type 1 diabetes - Results from 13,612 patients in a national diabetes register

OBJECTIVE - This study was designed to investigate the clinical characteristics of a large type 1 diabetic population and to evaluate the degree of fulfillment of recently updated treatment goals. RESEARCH DESIGN AND METHODS - The Swedish National Diabetes Register was initiated in 1996 as a tool for quality assurance in diabetes care. A1C levels, treatment, and risk factors were analyzed in two cross-sectional samples of 9,424 patients in 1997 and 13,612 patients in 2004 and in a smaller longitudinal sample from 1997 to 2004. RESULTS - Mean A1C decreased from 8.2 +/- 1.3% in 1997 to 8.0 +/- 1.2% in 2004 (P < 0.001). The proportion of patients reaching A1C < 7.0% increased from 17.4 to 21.2% in 2004. A slow but significant improvement in blood pressure levels was seen, but only 61.3% reached the blood pressure goal of < 130/80 mmHg in 2004. Lipid control improved, and the use of lipid-lowering drugs increased. Among patients treated with lipid-lowering agents, 38% reached the goal of total cholesterol < 4.5 mmol/l, and 48% reached the goal of LDL cholesterol < 2.5 mmol/l. Successful long-term glycemic, and blood pressure control were both independently predicted by low BMI and the absence of microalbuminuria in 1997. CONCLUSIONS - In this large cohort of type 1 diabetic patients, there was a slow improvement in glycemic and risk factor control from 1997 to 2004, although the gap between the clinical results and current Swedish and American treatment goals is still unsatisfactory. It is crucial that additional measures be taken to improve risk factor control in type 1 diabetic patients

Risk for developing perianal abscess in type 1 and type 2 diabetes and the impact of poor glycemic control

Purpose: The primary aim of this study was to see whether perianal abscess rate differs between patients with type 1 and type 2 diabetes. A secondary aim was to determine whether poor glycemic control increases the risk for perianal abscess. Methods: Data from the Swedish National Diabetes Registry and the Swedish National Patient Registry between January 2008 and June 2015 were matched. The risk for anal abscess was evaluated in univariate and multivariate analyses with type of diabetes, HbA1c level, BMI, and various diabetes complications as independent factors. Results: Patients with type 1 diabetes had a lower rate of perianal abscess than patients with type 2 diabetes when adjusted for HbA1c, sex, and age (OR 0.65; 95% CI 0.57–0.73). The risk for perianal abscess increased with higher HbA1c. Incidence of perianal abscess was also elevated in diabetes patients with complications related to poor glycemic control such as ketoacidosis and coma (OR 2.63; 95% CI 2.06–3.35), gastroparesis, and polyneuropathy (OR 1.81; 95% CI 1.41–2.32). Conclusions: The prevalence of perianal abscess was higher among patients with type 2 diabetes than those with type 1, suggesting that metabolic derangement may be more important than autoimmune factors. Poor glycemic control was associated with higher risk for perianal abscess

High HbA1c Levels Are Associated With Development of Trigger Finger in Type 1 and Type 2 Diabetes : An Observational Register-Based Study From Sweden

OBJECTIVE: Trigger finger (TF) is a hand disorder causing the fingers to painfully lock in flexion. Diabetes is a known risk factor; however, whether strict glycemic control effectively lowers risk of TF is unknown. Our aim was to examine whether high HbA1c was associated with increased risk of TF among individuals with diabetes.RESEARCH DESIGN AND METHODS: The Swedish National Diabetes Register (NDR) was cross-linked with the health care register of the Region of Skåne in southern Sweden. In total, 9,682 individuals with type 1 diabetes (T1D) and 85,755 individuals with type 2 diabetes (T2D) aged ≥18 years were included from 2004 to 2019. Associations between HbA1c and TF were calculated with sex-stratified, multivariate logistic regression models with 95% CIs, with adjustment for age, duration of diabetes, BMI, and systolic blood pressure.RESULTS: In total, 486 women and 271 men with T1D and 1,143 women and 1,009 men with T2D were diagnosed with TF. Increased levels of HbA1c were associated with TF among individuals with T1D (women OR 1.26 [95% CI 1.1-1.4], P = 0.001, and men 1.4 [1.2-1.7], P < 0.001) and T2D (women 1.14 [95% CI 1.2-1.2], P < 0.001, and men 1.12 [95% CI 1.0-1.2], P = 0.003).CONCLUSIONS: Hyperglycemia increases the risk of developing TF among individuals with T1D and T2D. Optimal treatment of diabetes seems to be of importance for prevention of diabetic hand complications such as TF

Quality of life in chronic conditions using patient-reported measures and biomarkers : a DEA analysis in type 1 diabetes

BACKGROUND: A chronic disease impacts a patient's daily life, with the burden of symptoms and managing the condition, and concerns of progression and disease complications. Such aspects are captured by Patient-Reported Outcomes Measures (PROM), assessments of e.g. wellbeing. Patient-Reported Experience Measures (PREM) assess patients' experiences of healthcare and address patient preferences. Biomarkers are useful for monitoring disease activity and treatment effect and determining risks of progression and complications, and they provide information on current and future health. Individuals may differ in which among these aspects they consider important. We aimed to develop a measure of quality of life using biomarkers, PROM and PREM, that would provide an unambiguous ranking of individuals, without presuming any specific set of importance weights. We anticipated it would be useful for studying needs and room for improvement, estimating the effects of interventions and comparing alternatives, and for developing healthcare with a broad focus on the individual. We wished to examine if efficiency analysis could be used for this purpose, in an application to individuals with type 1 diabetes.RESULTS: We used PROM and PREM data linked to registry data on risk factors, in a large sample selected from the National Diabetes Registry in Sweden. Efficiency analysis appears useful for evaluating the situation of individuals with type 1 diabetes. Quality of life was estimated as efficiency, which differed by age. The contribution of different components to quality of life was heterogeneous, and differed by gender, age and duration of diabetes. Observed quality of life shortfall was mainly due to inefficiency, and to some extent due to the level of available inputs.CONCLUSIONS: The efficiency analysis approach can use patient-reported outcomes measures, patient-reported experience measures and comorbidity risk factors to estimate quality of life with a broad focus on the individual, in individuals with type 1 diabetes. The approach enables ranking and comparisons using all these aspects in parallel, and allows each individual to express their own view of which aspects are important to them. The approach can be used for policy regarding interventions on inefficiency as well as healthcare resource allocation, although currently limited to type 1 diabetes