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

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 <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