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Tancredi M.,Gothenburg University | Tancredi M.,NU Hospital Group | Rosengren A.,Gothenburg University | Kosiborod M.,Saint Lukes Mid America Heart Institute | And 8 more authors.
New England Journal of Medicine | Year: 2015

BACKGROUND The excess risks of death from any cause and death from cardiovascular causes among persons with type 2 diabetes and various levels of glycemic control and renal complications are unknown. In this registry-based study, we assessed these risks according to glycemic control and renal complications among persons with type 2 diabetes. METHODS We included patients with type 2 diabetes who were registered in the Swedish National Diabetes Register on or after January 1, 1998. For each patient, five controls were randomly selected from the general population and matched according to age, sex, and county. All the participants were followed until December 31, 2011, in the Swedish Registry for Cause-Specific Mortality. RESULTS The mean follow-up was 4.6 years in the diabetes group and 4.8 years in the control group. Overall, 77,117 of 435,369 patients with diabetes (17.7%) died, as compared with 306,097 of 2,117,483 controls (14.5%) (adjusted hazard ratio, 1.15; 95% confidence interval [CI], 1.14 to 1.16). The rate of cardiovascular death was 7.9% among patients versus 6.1% among controls (adjusted hazard ratio, 1.14; 95% CI, 1.13 to 1.15). The excess risks of death from any cause and cardiovascular death increased with younger age, worse glycemic control, and greater severity of renal complications. As compared with controls, the hazard ratio for death from any cause among patients younger than 55 years of age who had a glycated hemoglobin level of 6.9% or less (≤52 mmol per mole of nonglycated hemoglobin) was 1.92 (95% CI, 1.75 to 2.11); the corresponding hazard ratio among patients 75 years of age or older was 0.95 (95% CI, 0.94 to 0.96). Among patients with normoalbuminuria, the hazard ratio for death among those younger than 55 years of age with a glycated hemoglobin level of 6.9% or less, as compared with controls, was 1.60 (95% CI, 1.40 to 1.82); the corresponding hazard ratio among patients 75 years of age or older was 0.76 (95% CI, 0.75 to 0.78), and patients 65 to 74 years of age also had a significantly lower risk of death (hazard ratio, 0.87; 95% CI, 0.84 to 0.91). CONCLUSIONS Mortality among persons with type 2 diabetes, as compared with that in the general population, varied greatly, from substantial excess risks in large patient groups to lower risks of death depending on age, glycemic control, and renal complications. © 2015 Massachusetts Medical Society.


Lind M.,NUHospital Organization | Lind M.,Gothenburg University | Kosiborod M.,Saint Lukes Mid America Heart Institute | Kosiborod M.,University of Missouri - Kansas City | And 9 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: The excess risk of death from any cause and of death from cardiovascular causes is unknown among patients with type 1 diabetes and various levels of glycemic control. We conducted a registry-based observational study to determine the excess risk of death according to the level of glycemic control in a Swedish population of patients with diabetes. METHODS: We included in our study patients with type 1 diabetes registered in the Swedish National Diabetes Register after January 1, 1998. For each patient, five controls were randomly selected from the general population and matched according to age, sex, and county. Patients and controls were followed until December 31, 2011, through the Swedish Register for Cause-Specific Mortality. RESULTS: The mean age of the patients with diabetes and the controls at baseline was 35.8 and 35.7 years, respectively, and 45.1% of the participants in each group were women. The mean follow-up in the diabetes and control groups was 8.0 and 8.3 years, respectively. Overall, 2701 of 33,915 patients with diabetes (8.0%) died, as compared with 4835 of 169,249 controls (2.9%) (adjusted hazard ratio, 3.52; 95% confidence interval [CI], 3.06 to 4.04); the corresponding rates of death from cardiovascular causes were 2.7% and 0.9% (adjusted hazard ratio, 4.60; 95% CI, 3.47 to 6.10). The multivariable-adjusted hazard ratios for death from any cause according to the glycated hemoglobin level for patients with diabetes as compared with controls were 2.36 (95% CI, 1.97 to 2.83) for a glycated hemoglobin level of 6.9% or lower (≤52 mmol per mole), 2.38 (95% CI, 2.02 to 2.80) for a level of 7.0 to 7.8% (53 to 62 mmol per mole), 3.11 (95% CI, 2.66 to 3.62) for a level of 7.9 to 8.7% (63 to 72 mmol per mole), 3.65 (95% CI, 3.11 to 4.30) for a level of 8.8 to 9.6% (73 to 82 mmol per mole), and 8.51 (95% CI, 7.24 to 10.01) for a level of 9.7% or higher (≥83 mmol per mole). Corresponding hazard ratios for death from cardiovascular causes were 2.92 (95% CI, 2.07 to 4.13), 3.39 (95% CI, 2.49 to 4.61), 4.44 (95% CI, 3.32 to 5.96), 5.35 (95% CI, 3.94 to 7.26), and 10.46 (95% CI, 7.62 to 14.37). CONCLUSIONS: In our registry-based observational study, patients with type 1 diabetes and a glycated hemoglobin level of 6.9% or lower had a risk of death from any cause or from cardiovascular causes that was twice as high as the risk for matched controls. Copyright © 2014 Massachusetts Medical Society. All rights reserved.


PubMed | Statistiska Konsultgruppen, University of Missouri - Kansas City and Gothenburg University
Type: | Journal: Diabetic medicine : a journal of the British Diabetic Association | Year: 2016

To estimate the risk of stroke in people with Type 2 diabetes with different blood pressure levels compared with the risk in the general population in Sweden.This prospective case-control study included 408 076 people with Type 2 diabetes, aged 18 years, and free of prior stroke, registered in the Swedish National Diabetes Register 1998-2011. Age- and sex-matched control subjects (n = 1 913 507) without stroke from the general population were included. Stroke diagnoses were retrieved using International Classification of Disease codes from the Swedish patient and death registers. Cox hazard ratios and 95% confidence intervals (CIs) were estimated at six different blood pressure levels.During a median follow-up of 4 years, 19 548 (4.8%) people with Type 2 diabetes and 61 690 (3.2%) without diabetes were diagnosed with stroke, corresponding to an adjusted hazard ratio of 1.43 (95% CI 1.41-1.46) for people with Type 2 diabetes as a group. Compared with people without diabetes, the risk of stroke for people with Type 2 diabetes with different blood pressure levels was significantly higher, starting at blood pressure levels > 130/80 mmHg. Hazard ratios for stroke were 1.20 (95% CI 1.16-1.24), 1.47 (95% CI 1.43-1.50), and 1.97 (95% CI 1.90-2.03) for blood pressure categories of 130-139/80-89 mmHg, 140-159/90-99 mmHg and 160/ 100 mmHg, respectively, after adjustment for age, sex, diabetes duration, being born in Sweden, maximum education level and baseline comorbidities.People with Type 2 diabetes and blood pressure < 130/80 mmHg had a risk of stroke similar to that of the general population.


Carlsson B.-M.,SAS Hospital Organization | Carlsson B.-M.,Gothenburg University | Attvall S.,Gothenburg University | Attvall S.,Sahlgrenska University Hospital | And 6 more authors.
Diabetes Technology and Therapeutics | Year: 2013

Aim: This study examined long-term effects of continuous subcutaneous insulin infusion (CSII) in clinical practice on glycemic control in patients with type 1 diabetes. Subjects and Methods: We evaluated all type 1 diabetes patients at 10 diabetes outpatient clinics in Sweden who had been treated with CSII for at least 5.5 years and had valid glycated hemoglobin (HbA1c) data before starting pump use and at 5 years±6 months. Controls treated with multiple daily insulin injections (MDI) over a time-matched period were also evaluated. Results: There were 331 patients treated with CSII at least 5.5 years at the 10 clinics. Of these, 272 (82%) fulfilled the inclusion criteria. Patients treated with CSII were younger than those treated with MDI (mean age, 38.6 vs. 45.6 years; P<0.001), more were women (56% vs. 43%; P<0.001), and diabetes duration was shorter (mean, 15.1 years vs. 20.1 years; P<0.001). After adjusting for variables differing at baseline and influencing the change in HbA1c over the study period, the reduction in HbA1c remained statistically significant at 5 years and was estimated to be 0.20% (95% confidence interval [CI] 0.07-0.32) (2.17 mmol/mol [95% CI 0.81-3.53]) (P=0.002). The corresponding adjusted reduction at years 1 and 2 was 0.42% (95% CI 0.31-0.53) (4.59 mmol/mol [95% CI 3.41-5.77]) (P<0.001) and 0.43% (95% CI 0.31-0.55) (4.71 mmol/mol [95% CI 3.38-6.04]) (P<0.001), respectively. The effect of insulin pump use versus controls on HbA1c decreased significantly with time (P<0.001). Conclusions: Use of CSII in clinical practice in Sweden is associated with an approximately 0.2% (2 mmol/mol) reduction in HbA1c after 5 years. © Mary Ann Liebert, Inc.


Larsson A.,Sahlgrenska University Hospital | Wigren S.,Bone Solutions | Andersson M.,Bone Solutions | Ekeroth G.,Statistiska Konsultgruppen | And 2 more authors.
Otology and Neurotology | Year: 2012

Objective: The protocol for bone-anchored hearing implants (e.g., Baha*) surgery involves reduction of soft tissues around the abutment to minimize the risk of skin-related complications. It is hypothesized that good soft tissue outcomes may be achieved without performing skin reduction if improved abutment designs and/or materials are used that provide enhanced integration with surrounding soft tissues. The aim of the study was to investigate soft tissue response to different abutment designs/materials. Methods: Thirty-six Baha implants and abutments were inserted in the skull of six sheep without performing soft tissue reduction. Four different abutments were used: 1) standard Baha abutments, 2) hydroxyapatite-coated standard Baha abutments, 3) concave titanium abutments, and 4) hydroxyapatite-coated concave abutments. Healing times of 1, 2, and 4 weeks were used (2 animals per time point). Samples were analyzed using descriptive histology and morphometric measurements, and results were compared using Wilcoxon's signed-ranked test. Results: Histologic assessment showed healthy soft tissues around the abutments with limited or no signs of inflammation. Hydroxyapatite-coated abutments showed tight adherence with dermis and limited epidermal downgrowth and pocket formation. Weaker adherence, often associated with significant epidermal downgrowth and pocket formation, was noted for noncoated titanium abutments. The mean pocket depth for abutment types A, B, C, and D was 1.38, 0.42, 1.51, and 0.24 mm, respectively. The difference between C and D was statistically significant (p = 0.031). Conclusion: The results showed enhanced dermal adherence and reduced epidermal downgrowth and pocket formation for hydroxyapatite-coated abutments, with the most significant effect recorded for the hydroxyapatite-coated abutments with a concave shape. © 2012, Otology & Neurotology, Inc.


PubMed | University of Amsterdam, Thomas Jefferson University, University of Washington, Statistiska Konsultgruppen and 4 more.
Type: Journal Article | Journal: Journal of diabetes science and technology | Year: 2016

Using the standard venous reference for the evaluation of continuous glucose monitoring (CGM) systems could possibly negatively affect measured CGM accuracy since CGM are generally calibrated with capillary glucose and venous and capillary glucose concentrations differ. We therefore aimed to quantify the effect of using capillary versus venous glucose reference samples on estimated accuracy in capillary calibrated CGM.We evaluated 41 individuals with type 1 diabetes mellitus (T1DM) using the Dexcom G4 CGM system over 6 days. Patients calibrated their CGM devices with capillary glucose by means of the HemoCue system. During 2 visits, capillary and venous samples were simultaneously measured by HemoCue and compared to concomitantly obtained CGM readings. The mean absolute relative difference (MARD) was calculated using capillary and venous reference samples.Venous glucose values were 0.83 mmol/L (15.0 mg/dl) lower than capillary values over all glycemic ranges, P < .0001. Below 4 mmol/l (72 mg/dl), the difference was 1.25 mmol/l (22.5 mg/dl), P = .0001, at 4-10 mmol/l (72-180 mg/dl), 0.67 mmol/l (12.0 mg/dl), P < .0001 and above 10 mmol/l (180 mg/dl), 0.95 mmol/l (17.1 mg/dl), P < .0001. MARD was 11.7% using capillary values as reference compared to 13.7% using venous samples, P = .037. Below 4 mmol/l (72 mg/dl) MARD was 16.6% and 31.8%, P = .048, at 4-10 mmol/l (72-180 mg/dl) 12.1% and 12.6%, P = .32, above 10 mmol/l (180 mg/dl) 8.7% and 9.2%, P = .82.Using capillary glucose concentrations as reference to evaluate the accuracy of CGM calibrated with capillary samples is associated with a lower MARD than using venous glucose as the reference. Capillary glucose concentrations were significantly higher than venous in all glycemic ranges.


PubMed | Statistiska konsultgruppen, Saint Lukes Mid America Heart Institute, NU Hospital Group and Gothenburg University
Type: Journal Article | Journal: Journal of diabetes science and technology | Year: 2016

A substantial excess risk of mortality still exists in persons with type 1 diabetes. The aim of this study was to evaluate the excess risk of mortality in persons with type 1 diabetes without renal complications who target goals for glycemic control and are nonsmokers. Furthermore, we evaluated risk factors of death due to hypoglycemia or ketoacidosis in young adults with type 1 diabetes.We evaluated a cohort based on 33 915 persons with type 1 diabetes and 169 249 randomly selected controls from the general population matched on age, sex, and county followed over a mean of 8.0 and 8.3 years, respectively. Hazard ratios (HRs) for all-cause and cardiovascular disease (CVD) mortality for persons with type 1 diabetes versus controls were estimated.The adjusted HRs for all-cause and CVD mortality for persons with type 1 diabetes without renal complications (normoalbuminuria and eGFR 60 ml/min) and HbA1c 6.9% (52 mmol/mol) compared to controls were 1.22 (95% CI 0.98-1.52) and 1.03 (95% CI 0.66-1.60), respectively. The HRs increased with higher updated mean HbA1c. For nonsmokers in this group, the HRs for all-cause and CVD mortality were somewhat lower: 1.11 (95% CI 0.87-1.42) and 0.89 (95% CI 0.53-1.48) at updated mean HbA1c 6.9% (52 mmol/mol). HRs for significant predictors for deaths due to hypoglycemia or ketoacidosis in persons < 50 years were male sex 2.40 (95% CI 1.27-4.52), smoking 2.86 (95% CI 1.57-5.22), lower educational level 3.01 (95% CI 1.26-7.22), albuminuria or advanced kidney disease 2.83 (95% CI 1.63-4.93), earlier hospital diagnosis of hypoglycemia or ketoacidosis 2.30 (95% CI 1.20-4.42), and earlier diagnosis of intoxication 2.53 (95% CI 1.06-6.04).If currently recommended HbA1c targets can be reached, renal complications and smoking avoided in persons with type 1 diabetes, the excess risk of mortality will likely converge substantially to that of the general population.


PubMed | Statistiska Konsultgruppen, University of Washington, Karolinska University Hospital, Profil and 4 more.
Type: Journal Article | Journal: Journal of diabetes science and technology | Year: 2016

The majority of individuals with type 1 diabetes today have glucose levels exceeding guidelines. The primary aim of this study was to evaluate whether continuous glucose monitoring (CGM), using the Dexcom G4 stand-alone system, improves glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections (MDI).Individuals with type 1 diabetes and inadequate glycemic control (HbA1c 7.5% = 58 mmol/mol) treated with MDI were randomized in a cross-over design to the Dexcom G4 versus conventional care for 6 months followed by a 4-month wash-out period. Masked CGM was performed before randomization, during conventional treatment, and during the wash-out period to evaluate effects on hypoglycemia, hyperglycemia, and glycemic variability. Questionnaires were used to evaluate diabetes treatment satisfaction, fear of hypoglycemia, hypoglycemia confidence, diabetes-related distress, overall well-being, and physical activity during the different phases of the trial. The primary endpoint was the difference in HbA1c at the end of each treatment phase.A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016.It is expected that the results of this study will establish whether using the Dexcom G4 stand-alone system in individuals with type 1 diabetes treated with MDI improves glycemic control, reduces hypoglycemia, and influences quality-of-life indicators and glycemic variability.


Lind M.,Gothenburg University | Garcia-Rodriguez L.A.,Spanish Center for Pharmacoepidemiologic Research | Booth G.L.,Li Ka Shing Knowledge Institute | Cea-Soriano L.,Spanish Center for Pharmacoepidemiologic Research | And 3 more authors.
Diabetologia | Year: 2013

Aims/hypothesis: The aim of this study was to determine the contemporary rate ratio of mortality and changes over time in individuals with vs without diabetes. Methods: Annual age- and sex-adjusted mortality rates were compared for adults (>20 years) with and without diabetes in Ontario, Canada, and the UK from January 1996 to December 2009 using The Health Improvement Network (THIN) and Ontario databases. The total number of individuals evaluated increased from 8,757,772 in 1996 to 12,696,305 in 2009. Results: The excess risk of mortality for individuals with diabetes in both cohorts was significantly lower during later vs earlier years of the follow-up period (1996-2009). In Ontario the diabetes mortality rate ratio decreased from 1.90 (95% CI 1.86, 1.94) in 1996 to 1.51 (1.48, 1.54) in 2009, and in THIN from 2.14 (1.97, 2.32) to 1.65 (1.57, 1.72), respectively. In Ontario and THIN, the mortality rate ratios among diabetic patients in 2009 were 1.67 (1.61, 1.72) and 1.81 (1.68, 1.94) for those aged 65-74 years and 1.11 (1.10, 1.13) and 1.19 (1.14, 1.24) for those aged over 74 years, respectively. Corresponding rate ratios in Ontario and THIN were 2.45 (2.36, 2.54) and 2.64 (2.39, 2.89) for individuals aged 45-64 years, and 4.89 (4.35, 5.45) and 5.18 (3.73, 6.69) for those aged 20-44 years. Conclusions/interpretation: The excess risk of mortality in individuals with vs without diabetes has decreased over time in both Canada and the UK. This may be in part due to earlier detection and higher prevalence of early diabetes, as well as to improvements in diabetes care. © 2013 Springer-Verlag Berlin Heidelberg.


Lind M.,Gothenburg University | Lind M.,NU Hospital Organization | Pivodic A.,Statistiska Konsultgruppen | Cea-Soriano L.,Spanish Center for Pharmacoepidemiologic Research | And 4 more authors.
Diabetologia | Year: 2014

Aims/hypothesis: The aim of this work was to study levels of HbA 1c and patterns of adjusting glucose-lowering drugs in patients with impaired glycaemic control over 10 years after diagnosis of type 2 diabetes. Methods: We studied 4,529 individuals in The Health Improvement Network Database newly diagnosed with type 2 diabetes in the year 2000. Results: From 6 months to 10 years after diagnosis, the HbA1c increased from 7.04% (53.4 mmol/mol) to 7.49% (58.3 mmol/mol) (average annual change: 0.047% [0.51 mmol/mol]). The greatest annual change occurred between 6 months and 2 years (0.21% [2.30 mmol/mol] increase per year, p<0.001), followed by the 2-5 year time period (0.033% [0.36 mmol/mol] increase per year, p<0.001). No significant increase in HbA1c occurred between 5 and 10 years (p=0.20). In multivariable analyses, patients who were younger (p<0.001), with higher BMI (p=0.033) and who were current insulin users (p=0.024) at diagnosis had greater increases in HbA1c between 6 months and 2 years. For individuals with HbA1c above 7.0% (53 mmol/mol) the mean time to next measurement of HbA1c was 0.53 years and increase in doses or changes to other glucose-lowering medications were performed in 26% of cases. Conclusions/interpretation: HbA1c increases by approximately 0.5% (5 mmol/mol) over 10 years after diagnosis of type 2 diabetes, with the main increase appearing in the first years after diagnosis. More frequent monitoring of HbA1c and adjustments of glucose-lowering drugs may be essential to prevent the decline. © 2014 Springer-Verlag.

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