A Longitudinal Study of Diabetes Mellitus : With Special Reference to Incidence and Prevalence, and to Determinants of Macrovascular Complications and Mortality

Objectives. To investigate diabetes prevalence, incidence, mortality trends, the effects of hyperglycaemia and blood pressure, diabetes and hypertension treatment, and the effect of screening detection on total and cardiovascular disease (CVD), myocardial infarction (MI) and stroke incidence. Study population and methods. Between 1972 and 2001 all patients with diabetes, some detected clinically and some by case-finding procedures (screening), were entered in a diabetes register at Laxå Primary Health Care Center in Sweden. The register included information on medical treatment and laboratory data as well as information on mortality and morbidity from National Registers. The register was supplemented with five non-diabetic subjects, matched to each diabetes patients by age, sex, and year of detection. Results. During the study period 776 new diabetes cases was found, 36 type 1 diabetes mellitus and 740 type 2 diabetes mellitus. Age standardised incidence and prevalence rates for type 1 and type 2 diabetes did not increase over time. Diabetic patients had 17% higher mortality rate than non-diabetic persons, 22% in women and 13% in men. The corresponding over-mortality in CVD was 33%, 41% in women and 27% in men. CVD mortality decreased across time in non-diabetic subjects and in diabetic men but not in diabetic women. Results regarding coronary heart disease (CHD) were similar. CVD incidence increased with fasting blood glucose (FBG), body mass index (BMI), mean arterial blood pressure (MABP), and decreased with metformin treatment and sulfonylurea. Myocardial infarction incidence increased with FBG, BMI and MABP, and decreased with metformin treatment. Stroke incidence increased with MABP. There was no difference in prognoses between those detected by screening or clinically. Conclusions. Diabetes prevalence and incidence did not change over time. The over-mortality according to diabetes was moderate. CVD and MI during follow up were negatively affected by hypertension and hyperglycaemia, and positively by pharmacological diabetic treatment. For stroke no pharmacological protective effect was seen. Screening did not improve prognosis

A Longitudinal Study of Diabetes Mellitus : With Special Reference to Incidence and Prevalence, and to Determinants of Macrovascular Complications and Mortality

Objectives. To investigate diabetes prevalence, incidence, mortality trends, the effects of hyperglycaemia and blood pressure, diabetes and hypertension treatment, and the effect of screening detection on total and cardiovascular disease (CVD), myocardial infarction (MI) and stroke incidence. Study population and methods. Between 1972 and 2001 all patients with diabetes, some detected clinically and some by case-finding procedures (screening), were entered in a diabetes register at Laxå Primary Health Care Center in Sweden. The register included information on medical treatment and laboratory data as well as information on mortality and morbidity from National Registers. The register was supplemented with five non-diabetic subjects, matched to each diabetes patients by age, sex, and year of detection. Results. During the study period 776 new diabetes cases was found, 36 type 1 diabetes mellitus and 740 type 2 diabetes mellitus. Age standardised incidence and prevalence rates for type 1 and type 2 diabetes did not increase over time. Diabetic patients had 17% higher mortality rate than non-diabetic persons, 22% in women and 13% in men. The corresponding over-mortality in CVD was 33%, 41% in women and 27% in men. CVD mortality decreased across time in non-diabetic subjects and in diabetic men but not in diabetic women. Results regarding coronary heart disease (CHD) were similar. CVD incidence increased with fasting blood glucose (FBG), body mass index (BMI), mean arterial blood pressure (MABP), and decreased with metformin treatment and sulfonylurea. Myocardial infarction incidence increased with FBG, BMI and MABP, and decreased with metformin treatment. Stroke incidence increased with MABP. There was no difference in prognoses between those detected by screening or clinically. Conclusions. Diabetes prevalence and incidence did not change over time. The over-mortality according to diabetes was moderate. CVD and MI during follow up were negatively affected by hypertension and hyperglycaemia, and positively by pharmacological diabetic treatment. For stroke no pharmacological protective effect was seen. Screening did not improve prognosis

A Longitudinal Study of Diabetes Mellitus : With Special Reference to Incidence and Prevalence, and to Determinants of Macrovascular Complications and Mortality

Objectives. To investigate diabetes prevalence, incidence, mortality trends, the effects of hyperglycaemia and blood pressure, diabetes and hypertension treatment, and the effect of screening detection on total and cardiovascular disease (CVD), myocardial infarction (MI) and stroke incidence. Study population and methods. Between 1972 and 2001 all patients with diabetes, some detected clinically and some by case-finding procedures (screening), were entered in a diabetes register at Laxå Primary Health Care Center in Sweden. The register included information on medical treatment and laboratory data as well as information on mortality and morbidity from National Registers. The register was supplemented with five non-diabetic subjects, matched to each diabetes patients by age, sex, and year of detection. Results. During the study period 776 new diabetes cases was found, 36 type 1 diabetes mellitus and 740 type 2 diabetes mellitus. Age standardised incidence and prevalence rates for type 1 and type 2 diabetes did not increase over time. Diabetic patients had 17% higher mortality rate than non-diabetic persons, 22% in women and 13% in men. The corresponding over-mortality in CVD was 33%, 41% in women and 27% in men. CVD mortality decreased across time in non-diabetic subjects and in diabetic men but not in diabetic women. Results regarding coronary heart disease (CHD) were similar. CVD incidence increased with fasting blood glucose (FBG), body mass index (BMI), mean arterial blood pressure (MABP), and decreased with metformin treatment and sulfonylurea. Myocardial infarction incidence increased with FBG, BMI and MABP, and decreased with metformin treatment. Stroke incidence increased with MABP. There was no difference in prognoses between those detected by screening or clinically. Conclusions. Diabetes prevalence and incidence did not change over time. The over-mortality according to diabetes was moderate. CVD and MI during follow up were negatively affected by hypertension and hyperglycaemia, and positively by pharmacological diabetic treatment. For stroke no pharmacological protective effect was seen. Screening did not improve prognosis

A lifelong struggle for a lighter tomorrow : A qualitative study on experiences of obesity in primary healthcare patients

  Aim To describe experiences of living with obesity before the start of a group-based lifestyle intervention. Background Obesity is a chronic disease that affects a person's physical and psychological health. Increased knowledge of experiences of living with obesity is required. Design A qualitative study with a descriptive design. Methods Semi-structured individual interviews with 17 participants living with obesity (Body Mass Index 32–49) were conducted between October and November 2019. The interviews were analysed using qualitative content analysis. The COREQ checklist was followed. Results The analysis resulted in one main theme: Struggling for a lighter tomorrow and three subthemes: Suffering, Resilience and Need for support in making changes. For the majority of the participants, living with obesity was a lifelong struggle involving suffering on different levels. Yet despite this, the participants had not given up and hoped for a better life. They showed a degree of resilience and motivation, and a perceived ability to achieve lifestyle changes. However, there was a pronounced need for support to help them achieve this. Conclusion Living with obesity is complex and carries a risk of medical complications as well as psychosocial suffering. Healthy lifestyle habits to achieve better health and to lose weight should be encouraged, taking patient resources into account. Patients also need help in handling weight stigmatisation, and both healthcare professionals and society must engage with this. Relevance to clinical practice Obesity is a chronic disease, and patients need ongoing support. Therefore, care for patients with obesity in primary health care must be further developed. Patient resources and strengths have to be acknowledged and encouraged in the process of helping them adopt healthy lifestyle habits. The findings of this study can contribute to ending weight stigmatisation by increasing the knowledge of living with obesity

Editor's Choice – Incidence of Lower Limb Amputations in Sweden from 2008 to 2017

Objective: This study examined the recent national and regional incidence of lower limb amputations (LLAs) in Sweden and their annual changes. Methods: This was an observational study using Swedish national register data. All initial amputations were identified in Sweden from 2008 to 2017 in individuals 18 years or older using the national inpatient register. The amputations were categorised into three levels: high proximal (through or above the knee joint), low proximal (through the tibia to through the ankle joint), and partial foot amputations. To examine the national and regional incidence and annual changes, the age, sex, and region specific population count each year was used as the denominator and Poisson regression or negative binomial regression models were used to estimate incidence rate ratios (IRRs) and 95% confidence intervals (CIs) adjusted for age and sex. Results: The national annual incidence of LLAs was 22.1 per 100 000 inhabitants, with a higher incidence in men (24.2) than in women (20.0). The incidence of LLAs (all levels combined) declined during the study period, with an IRR of 0.984 per year (95% CI 0.973 - 0.994). This was mainly due to a decrease in high proximal amputations (0.985, 95% CI 0.974 - 0.995) and low proximal amputations (0.973, 95% CI 0.962 - 0.984). No change in the incidence of partial foot amputations was observed (0.994, 95% CI 0.974 - 1.014). Such declines in LLA incidence (all levels combined) were observed in nine of the 21 regions. Compared with the national average and with adjustment for age, sex, diabetes, and artery disease, the regional IRR varied from 0.85 to 1.36 for all LLAs, from 0.67 to 1.61 for high proximal amputations, from 0.50 to 1.51 for low proximal amputations, and from 0.13 to 3.68 for partial foot amputations. Conclusion: The incidence of LLAs has decreased in Sweden. However, regional variations in incidence, time trends, and amputation levels warrant further research.De två sista författarna delar sistaförfattarskapet.</p

Exploring potential risk factors for lower limb amputation in people with diabetes-A national observational cohort study in Sweden

Aims: Risk factors for lower limb amputation (LLA) in individuals with diabetes have been under-studied. We examined how 1/demographic and socioeconomic, 2/medical, and 3/lifestyle risk factors may be associated with LLA in people with newly diagnosed diabetes. Methods: Using the Swedish national diabetes register from 2007 to 2016, we identified all individuals &gt;= 18 years with an incident diabetes diagnosis and no previous amputation. These individuals were followed from the date of diabetes diagnosis to amputation, emigration, death, or the end of the study in 2017 using data from the In-Patient Register and the Total Population Register. The cohort consisted of 66,569 individuals. Information about demographic, socioeconomic, medical, and lifestyle risk factors was ascertained around the time of the first recorded diabetes diagnosis, derived from the above-mentioned registers. Cox proportional hazard models were used to obtain hazard ratios (HR) with 95% confidence intervals (CI). Results: During the median follow-up time of 4 years, there were 133 individuals with LLA. The model adjusting for all variables showed a higher risk for LLA with higher age, HR 1.08 (95% CI 1.05-1.10), male sex, HR 1.57 (1.06-2.34), being divorced, HR 1.67 (1.07-2.60), smokers HR 1.99 (1.28-3.09), insulin treated persons HR 2.03 (1.10-3.74), people with low physical activity (PA) HR 2.05 (1.10-3.74), and people with an increased foot risk at baseline HR &gt; 4.12. People with obesity had lower risk, HR 0.46 (0.29-0.75). Conclusions: This study found a higher risk for LLA among people with higher age, male sex, who were divorced, had a higher foot risk group, were on insulin treatment, had lower PA levels, and were smokers. No significant association was found between risk for LLA and education level, country of origin, type of diabetes, blood glucose level, hypertension, hyperlipidemia, creatinine level, or glomerular filtration rate. Obesity was associated with lower risk for LLA. Identified variables may have important roles in LLA risk among people with diabetes

Dog ownership, glycaemic control and all-cause death in patients with newly diagnosed type 2 diabetes : a national cohort study

Aims: To evaluate whether dog ownership from the time of type 2 diabetes diagnosis improved glycaemic control, increased achievement of major guideline treatment goals or reduced the risk of all-cause death. Methods: Patients diagnosed with type 2 diabetes were followed by linkage of four Swedish national registers covering diabetes, dog ownership, socioeconomics, and mortality. Linear regression was used to estimate the mean yearly change in glycated haemoglobin (HbA1c). Cox survival analysis and logistic regression were used to analyse associations between dog ownership and all-cause death and achievement of treatment goals, respectively. Results: Of 218,345 individuals included, 8,352 (3.8%) were dog-owners. Median follow-up was 5.2 years. Dog-owners had worse yearly change in HbA1c, and were less likely to reach HbA1c, low-density lipoprotein (LDL), and systolic blood pressure (SBP) treatment goals than non-dog-owners (adjusted odds ratios [95% CI] of 0.93 [0.88-0.97], 0.91 [0.86-0.95], and 0.95 [0.90-1.00], respectively). There was no difference in the risk of all-cause death (adjusted hazard ratio [95% CI] 0.92 [0.81-1.04], dog owners versus not). Conclusion: Owning a dog when diagnosed with diabetes did not lead to better achievement of treatment goals or reduced mortality, but was in fact associated with a smaller reduction in HbA1c and reduced likelihood of achieving treatment goals

Health care registers can be instrumental for endpoint capture in clinical diabetes trials : example of microvascular complications in Swedish patients with type 2 diabetes

Aims SMARTEST is a register-based randomized clinical trial (RRCT) that compares dapagliflozin to metformin in early-stage type 2 diabetes. The primary outcome includes progression of microvascular complications based on data from the Swedish National Diabetes Register (NDR). In this sub-study, the aim was to validate microvascular complication variables in the NDR against electronic health records (EHRs). Methods Data were extracted from EHRs of 276 SMARTEST participants with a median observation period of 3 years in the Uppsala, orebro and Sormland counties and compared with NDR data. Agreement was determined for all corresponding data entries as well as for progression of microvascular complications after randomization. Results The agreement for all corresponding data entries was 98.9% (Intraclass Correlation Coefficient 0.999) for creatinine and eGFR, 95.1% for albuminuria, 91.6% for foot-at-risk and 98.2% for retinopathy status (Kappa 0.67-0.91). The agreement for progression of microvascular complications was 98.0% for CKD stage, 98.9% for albuminuria grade, 96.3% for foot-at-risk grade and 99.6% for retinopathy grade progression (Gwet's AC(1) 0.96-1.00). Conclusion Microvascular complication variables in the NDR show good agreement with EHR data. The use of a well-established national health care registry, exemplified by the NDR, for endpoint collection in RRCTs such as SMARTEST is supported by this study

A registry-based randomised trial comparing an SGLT2 inhibitor and metformin as standard treatment of early stage type 2 diabetes (SMARTEST) : Rationale, design and protocol

Aim: SGLT2 inhibitors have been shown to reduce cardiovascular and renal complications in type 2 diabetes (T2D) patients at high cardiovascular risk. Metformin is currently widely used as initial monotherapy in T2D but lacks convincing data to show that it reduces risk of complications. We aim to compare the SGLT2 inhibitor dapagliflozin and metformin as first-line T2D medication with regard to development of complications in a registry-based randomised controlled trial. Methods: The SGLT2 inhibitor or metformin as standard treatment of early stage type 2 diabetes (SMARTEST) trial will enrol 4300 subjects at 30-40 study sites in Sweden who will be randomised 1:1 to either metformin or dapagliflozin. Participants must have T2D duration &lt;4 years, no prior cardiovascular disease, and be either drug-naive or on monotherapy for T2D. Results: The primary endpoint is a composite of all-cause death, major adverse cardiovascular events and occurrence or progression of microvascular complications (retinopathy, nephropathy, diabetic foot lesions). Secondary endpoints include individual components of the primary endpoint, start of insulin therapy, risk factor biomarkers, patient-reported outcome measures, and cost-effectiveness analysis. Outcomes will primarily be assessed using nationwide healthcare registries. Conclusions: The SMARTEST trial will investigate whether dapagliflozin is superior to metformin in preventing complications in early stage T2D

Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention : a study protocol for a 12-month randomized controlled trial- the ROSEBUD study

Background: Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM. Methods: A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides. Discussion: Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings