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  • 1. Cameron, F. J.
    et al.
    Skinner, T. C.
    de Beaufort, C. E.
    Hoey, H.
    Swift, P. G. F.
    Aanstoot, H.
    Åman, Jan
    Örebro University, School of Health and Medical Sciences.
    Martul, P.
    Chiarelli, F.
    Daneman, D.
    Danne, T.
    Dorchy, H.
    Kaprio, E. A.
    Kaufman, F.
    Kocova, M.
    Mortensen, H. B.
    Njølstad, P. R.
    Phillip, M.
    Robertson, K. J.
    Schoenle, E. J.
    Urakami, T.
    Vanelli, M.
    Ackermann, R. W.
    Skovlund, S. E.
    Are family factors universally related to metabolic outcomes in adolescents with Type 1 diabetes?2008In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 25, no 4, p. 463-468Article in journal (Refereed)
    Abstract [en]

    AIMS: To assess the importance of family factors in determining metabolic outcomes in adolescents with Type 1 diabetes in 19 countries.

    METHODS: Adolescents with Type 1 diabetes aged 11-18 years, from 21 paediatric diabetes care centres, in 19 countries, and their parents were invited to participate. Questionnaires were administered recording demographic data, details of insulin regimens, severe hypoglycaemic events and number of episodes of diabetic ketoacidosis. Adolescents completed the parental involvement scale from the Diabetes Quality of Life for Youth--Short Form (DQOLY-SF) and the Diabetes Family Responsibility Questionnaire (DFRQ). Parents completed the DFRQ and a Parental Burden of Diabetes score. Glycated haemoglobin (HbA(1c)) was analysed centrally on capillary blood.

    RESULTS: A total of 2062 adolescents completed a questionnaire, with 2036 providing a blood sample; 1994 parents also completed a questionnaire. Family demographic factors that were associated with metabolic outcomes included: parents living together (t = 4.1; P < 0.001), paternal employment status (F = 7.2; d.f. = 3; P < 0.001), parents perceived to be over-involved in diabetes care (r = 0.11; P < 0.001) and adolescent-parent disagreement on responsibility for diabetes care practices (F = 8.46; d.f. = 2; P < 0.001). Although these factors differed between centres, they did not account for centre differences in metabolic outcomes, but were stronger predictors of metabolic control than age, gender or insulin treatment regimen.

    CONCLUSIONS: Family factors, particularly dynamic and communication factors such as parental over-involvement and adolescent-parent concordance on responsibility for diabetes care appear be important determinants of metabolic outcomes in adolescents with diabetes. However, family dynamic factors do not account for the substantial differences in metabolic outcomes between centres 

  • 2.
    Fadini, G. P.
    et al.
    Department of Medicine, Division of Metabolic Diseases, University of Padova, Padova, Italy.
    Feher, M.
    Beta Cell Diabetes Centre, Chelsea and Westminster Hospital, London, UK; University of Surrey, Guildford, UK.
    Hansen, T. K.
    Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.
    de Valk, H. W.
    Department of Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.
    Koefoed, M. M.
    Novo Nordisk A/S, Søborg, Denmark.
    Wolden, M.
    Novo Nordisk A/S, Søborg, Denmark.
    Zimmermann, E.
    Novo Nordisk A/S, Søborg, Denmark.
    Jendle, Johan
    Örebro University, School of Medical Sciences.
    Reduced rates of overall hypoglycaemia in patients with Type 1 diabetes after switching to insulin degludec: A European, multinational, multicentre, prospective, observational study (ReFLeCT)2019In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 36, no Suppl. 1, p. 60-60Article in journal (Other academic)
    Abstract [en]

    Aims: To evaluate the safety and effectiveness of switching to once‐daily insulin degludec (degludec) from other basal insulins in patients with Type 1 diabetes in routine clinical practice.

    Methods: ReFLeCT was a multicentre, prospective, observational study in seven European countries in patients (≥18 years) with Type 1 or Type 2 diabetes, whose physician planned to switch their basal insulin to degludec (ClinicalTrials.gov: NCT02392117). ReFLeCT comprised a four week baseline period (pre‐switch basal insulin) and a 12 month follow‐up period (degludec). For the Type 1 diabetes cohort presented here, primary endpoint was changed from baseline in the rate of overall hypoglycaemia recorded in patient diaries.

    Results: Baseline characteristics (mean [SD]) for patients with Type 1 diabetes (n = 556) were: age 47.4 (15.7) years, diabetes duration 21.4 (13.5) years, HbA1c 8.1 (1.3)% (65.0 [14.2]mmol/mol), fasting plasma glucose (FPG) 8.8 (3.9)mmol/l, pre‐switch basal insulin dose 25.0 (14.1)u/day, body mass index (BMI) 26.1 (4.7)kg/m2 and body weight 76.4 (15.6)kg. Estimated rate ratios of overall (0.80 [0.74; 0.88]95%CI), non‐severe (0.81 [0.74; 0.88]95%CI), severe (American Diabetes Association definition; 0.28 [0.14; 0.56]95%CI) and nocturnal (00:01−05:59am; 0.61 [0.50; 0.73]95%CI) hypoglycaemia illustrated significantly lower rates during 12 month follow‐up vs baseline. HbA1c, FPG and basal insulin dose decreased significantly by –0.15% [–0.23; –0.07]95%CI (–1.64mmol/mol [–2.51; –0.77]95%CI), –0.54mmol/l [–0.95; –0.14]95%CI and –2.21u/day [–2.90; –1.53]95%CI, respectively, and body weight was 0.79kg [0.38; 1.20]95%CI higher, at 12 month follow‐up vs baseline.

    Conclusion: Switching from other basal insulins to degludec significantly reduced the rates of hypoglycaemia and improved glycaemic control at lower basal insulin doses in patients with Type 1 diabetes in routine clinical practice.

  • 3.
    Fadini, G. P.
    et al.
    Department of Medicine, Division of Metabolic Diseases, University of Padova, Padova, Italy.
    Feher, M.
    Beta Cell Diabetes Centre, Chelsea and Westminster Hospital, London, UK; University of Surrey, Guildford, UK.
    Hansen, T. K.
    Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.
    de Valk, H. W.
    Department of Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.
    Koefoed, M. M.
    Novo Nordisk A/S, Søborg, Denmark.
    Wolden, M.
    Novo Nordisk A/S, Søborg, Denmark.
    Zimmermann, E.
    Novo Nordisk A/S, Søborg, Denmark.
    Jendle, Johan
    Örebro University, School of Medical Sciences.
    Reduced rates of overall hypoglycaemia in patients with Type 2 diabetes after switching to insulin degludec: A European, multinational, multicentre, prospective, observational study (ReFLeCT)2019In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 36, no Suppl. 1, p. 60-60Article in journal (Other academic)
    Abstract [en]

    Aims: To evaluate the safety and effectiveness of switching to once‐daily insulin degludec (degludec) from other basal insulins in patients with Type 2 diabetes in routine clinical practice.

    Methods: ReFLeCT was a multicentre, prospective, observational study in seven European countries in patients (≥18 years) with Type 1 or Type 2 diabetes, whose physician planned to switch their basal insulin to degludec (ClinicalTrials.gov:NCT02392117). ReFLeCT comprised a four week baseline period (pre‐switch basal insulin) and a 12 month follow‐up period (degludec). For the Type 2 diabetes cohort presented here, primary endpoint was changed from baseline in the rate of overall hypoglycaemia recorded in patient diaries.

    Results: Baseline characteristics (mean [SD]) for patients with Type 2 diabetes (n = 611) were: age 65.2 (9.6) years, diabetes duration 18.0 (9.5) years, HbA1c 8.2 (1.4)% (66.1 [15.3]mmol/mol), fasting plasma glucose (FPG) 9.0 (3.1)mmol/l, pre‐switch basal insulin dose 37.5 (33.9)u/day, body mass index (BMI) 31.1 (6.3)kg/m2, body weight 87.6 (19.6)kg and 421 (68.9%) patients used a basal‐bolus regimen. Estimated rate ratios of overall (0.46 [0.38; 0.56]95%CI), non‐severe (0.46 [0.38; 0.56]95%CI) and nocturnal (00:01−05:59am; 0.35 [0.20; 0.62]95%CI) hypoglycaemia illustrated significantly lower rates during 12 month follow‐up vs baseline (severe hypoglycaemia [American Diabetes Association definition], too few events for statistical analysis). HbA1c and FPG decreased significantly by −0.32% [−0.42; −0.22]95%CI (−3.50 mmol/mol [−4.59; −2.40]95%CI) and −0.84mmol/l [−1.09; −0.60]95%CI, respectively, with no significant changes in basal insulin dose or body weight at 12 month follow‐up vs baseline.

    Conclusion: Switching from other basal insulins to degludec reduced the rates of hypoglycaemia and improved glycaemic control in patients with Type 2 diabetes in routine clinical practice.

  • 4.
    Fadl, Helena E.
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Östlund, I. K. M.
    Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Magnuson, A. F. K.
    Statistical and Epidemiology Unit, Örebro University Hospital, Örebro, Sweden.
    Hanson, U. S. B.
    Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Maternal and neonatal outcomes and time trends of gestational diabetes mellitus in Sweden from 1991 to20032010In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 27, no 4, p. 436-441Article in journal (Refereed)
    Abstract [en]

    Aims To determine maternal and neonatal outcomes for women with gestational diabetes mellitus (GDM) in Sweden during 1991–2003, and to compare the outcomes in the two time periods.

    Methods This is a population-based cohort study using the Swedish Medical Birth Register data for the period 1991–2003. There were 1 260 297 women with singleton pregnancies registered during this time, of whom 10 525 were diagnosed with GDM, based on a 75 g oral glucose tolerance test. The main diagnostic criteria were fasting capillary whole blood glucose ≥ 6.1 mmol⁄l and 2 h blood glucose ≥ 9.0 mmol⁄l.

    Results Maternal characteristics differed significantly between the GDM and non-GDM group. Adjusted odds ratios (OR) were as follows: for pre-eclampsia, 1.81 (95% confidence interval (CI) 1.64–2.00); for shoulder dystocia, 2.74 (2.04–3.68); and for Caesarean section, 1.46 (1.38–1.54).No difference was seen in perinatal mortality, stillbirth rates, Apgar scores, fetal distress or transient tachypnoea. There was a markedly higher risk of large for gestational age,OR3.43 (3.21–3.67), and Erb’s palsy, OR 2.56 (1.96–3.32), in the GDMgroup, and statistically significant differences in prematurity < 37 weeks, birthweight > 4.5 kg, and major malformation, OR 1.19–1.71. No statistically significant improvement in outcomes was seen between the two study periods.

    Conclusions Women with GDM have higher risks of pre-eclampsia, shoulder dystocia and Caesarean section. Their infants are often large for gestational age and have higher risks of prematurity, Erb’s palsy and major malformations. These outcomes did not improve over time.

  • 5. Freemantle, N
    et al.
    Meneghini, L
    Christensen, T
    Wolden, M L
    Jendle, Johan
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Ratner, R
    Insulin degludec improves health-related quality of life (SF-36(®) ) compared with insulin glargine in people with Type 2 diabetes starting on basal insulin: a meta-analysis of phase 3a trials2013In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 30, no 2, p. 226-232Article in journal (Refereed)
    Abstract [en]

    AIM: To compare the effect of insulin degludec and insulin glargine on health-related quality of life in patients with Type 2 diabetes starting on insulin therapy.

    METHODS: Patient-level data from three open-label, randomized, treat-to-target trials of 26 or 52 weeks' duration were pooled using a weighted analysis in conjunction with a fixed-effects model. Insulin-naive patients received either insulin degludec (n = 1290) or insulin glargine (n = 632) once daily, in combination with oral anti-diabetic drugs. Glycaemic control was assessed via HbA(1c) and fasting plasma glucose concentrations. Rates of hypoglycaemia, defined as plasma glucose < 3.1 mmol/l (< 56 mg/dl), were recorded. Health-related quality of life was evaluated using the 36-item Short Form (SF-36(®) ) version 2 questionnaire. Statistical analysis was performed using a generalized linear model with treatment, trial, anti-diabetic therapy at baseline, gender, region and age as explanatory variables.

    RESULTS: Insulin degludec was confirmed as non-inferior to insulin glargine based on HbA(1c) concentrations. In each trial comprising the meta-analysis, fasting plasma glucose and confirmed overall and nocturnal (00.01-05.59 h) hypoglycaemia were all numerically or significantly lower with insulin degludec vs. insulin glargine. At endpoint, the overall physical health component score was significantly higher (better) with insulin degludec vs. insulin glargine [+0.66 (95% CI 0.04-1.28)], largely attributable to a difference [+1.10 (95% CI 0.22-1.98)] in the bodily pain domain score. In the mental domains, vitality was significantly higher with insulin degludec vs. insulin glargine [+0.81 (95% CI 0.01-1.59)].

    CONCLUSIONS: Compared with insulin glargine, insulin degludec leads to improvements in both mental and physical health status for patients with Type 2 diabetes initiating insulin therapy.

  • 6.
    Hildén, K.
    et al.
    Department of Obstetrics & Gynaecology, School of Medical Sciences, Örebro University, Örebro, Sweden.
    Hanson, U.
    School of Medical Sciences, Örebro University, Örebro, Sweden; Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Persson, M.
    Department of Medicine, Clinical Epidemiology Unit, Karolinska Universitetssjukhuset, Solna, Sweden.
    Magnuson, A.
    Örebro University, Örebro, Sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. School of Medicine, Western Sydney University, Campbelltown, NSW, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics & Gynaecology.
    Gestational diabetes and adiposity are independent risk factors for perinatal outcomes: a population based cohort study in Sweden2019In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 36, no 2, p. 151-157Article in journal (Refereed)
    Abstract [en]

    AIMS: To evaluate the interaction effects of gestational diabetes (GDM) with obesity on perinatal outcomes.

    METHODS: A population-based cohort study in Sweden excluding women without pre-gestational diabetes with a singleton birth between 1998 and 2012. Logistic regression was performed to evaluate the potential independent associations of GDM and BMI with adverse perinatal outcomes as well as their interactions. Main outcome measures were malformations, stillbirths, perinatal mortality, low Apgar score, fetal distress, prematurity and Erb's palsy.

    RESULTS: ) had significantly increased risks of all outcomes including stillbirth 1.51 (1.40-1.62) to 2.85 (2.52-3.22) and perinatal mortality 1.49 (1.40-1.59) to 2.83 (2.54-3.15).

    CONCLUSIONS: There is no interaction effect between GDM and BMI for the studied outcomes. Higher BMI and GDM are major independent risk factors for most serious adverse perinatal outcomes. More effective pre-pregnancy and antenatal interventions are required to prevent serious adverse pregnancy outcomes among women with either GDM or high BMI.

  • 7.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Hanson, Ulf
    Örebro University, School of Health Sciences. DeDepartment of Obstetrics and Gynaecology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden; Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Persson, M.
    Department of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Overweight and obesity: a remaining problem in women treated for severe gestational diabetes2016In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 33, no 8, p. 1045-1051Article in journal (Refereed)
    Abstract [en]

    Aim: To analyse the impact of overweight and obesity on the risk of adverse maternal outcomes and fetal macrosomia in pregnancies of women treated for severe gestational diabetes.

    Methods This was a population-based cohort study including all singleton pregnancies in Sweden without pre-existing diabetes in the period 1998-2012. Only mothers with an early- pregnancy BMI of ≥18.5 kg/m² were included. Logistic regression analysis was used to determine odds ratios with 95% CIs for maternal outcomes and fetal growth. Analyses were stratified by maternal gestational diabetes/non-gestational diabetes to investigate the impact of overweight/obesity in each group.

    Results: Of 1 249 908 singleton births, 13 057 were diagnosed with gestational diabetes (1.0%). Overweight/obesity had the same impact on the risks of caesarean section and fetal macrosomia in pregnancies with and without gestational diabetes, but the impact of maternal BMI on the risk of preeclampsia was less pronounced in women with gestational diabetes. Normal-weight women with gestational diabetes had an increased risk of caesarean section [odds ratio 1.26 (95% CI 1.16-1.37)], preeclampsia [odds ratio 2.03 (95% CI 1.71-2.41)] and large-for-gestational-age infants [odds ratio 2.25 (95% CI 2.06-2.46)]. Risks were similar in the overweight group without gestational diabetes, caesarean section [odds ratio 1.34 (1.33-1.36)], preeclampsia odds ratio [1.76 (95% CI 1.72-1.81)], large-for-gestational-age [odds ratio 1.76 (95% CI 1.74-1.79)].

    Conclusions: Maternal overweight and obesity is associated with similar increments in risks of adverse maternal outcomes and delivery of large-for-gestational-age infants in women with and without gestational diabetes. Obese women with gestational diabetes are defined as a high-risk group. Normal-weight women with gestational diabetes have similar risks of adverse outcomes to overweight women without gestational diabetes.

  • 8.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics & Gynaecology.
    Hanson, Ulf
    Department of Women’s and Children’s Health, Uppsala University, Sweden; School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Persson, M.
    Department of Medicine, Clinical Epidemiology Unit, Karolinska Universitetssjukhuset Solna, Karolinska Institutet, Sweden.
    Magnuson, A.
    Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics & Gynaecology.
    Are gestational diabetes and adiposity independent risk factors for perinatal outcomes?: A population based cohort study in Sweden2018In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491Article in journal (Refereed)
  • 9.
    Home, P. D.
    et al.
    Institute of Cellular Medicine, Diabetes, Newcastle University, Newcastle upon Tyne, UK.
    Meneghini, L.
    Miller School of Medicine, University of Miami, Miami FL, USA.
    Wendisch, U.
    Gemeinschaftspraxis für Innere Medizin und Diabetologie, Hamburg, Germany.
    Ratner, R. E.
    MedStar Health Research Institute, Hyattsville MD, USA.
    Johansen, T.
    Novo Nordisk A ⁄ S, Søborg, Denmark.
    Christensen, T. E.
    Novo Nordisk A ⁄ S, Søborg, Denmark.
    Jendle, Johan
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Endocrine and Diabetes Centre, Karlstad Hospital, Karlstad, Sweden.
    Roberts, A. P.
    Endocrine and Metabolic Unit, Royal Adelaide Hospital, Adelaide SA, Australia.
    Birkeland, K. I.
    Faculty of Medicine, Department of Endocrinology, Oslo University Hospital, University of Oslo, Oslo, Norway.
    Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes2012In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 29, no 6, p. 716-720Article in journal (Refereed)
    Abstract [en]

    Aims: The efficacy and safety of insulin degludec (degludec), a new-generation ultra-long-acting basal insulin, was compared with insulin glargine (glargine) in people with Type 1 diabetes mellitus in a 16-week, open-label, randomized trial. Health status, an important aspect of effective diabetes management, was also assessed.

    Methods: Degludec (n = 59) or glargine (n = 59) were injected once daily, with insulin aspart at mealtimes. Health status assessment utilized the validated Short Form 36 Health Survey, version 2, which has two summary component scores for mental and physical well-being, each comprising four domains.

    Results: At study end, HbA1c reductions were comparable between groups, but confirmed nocturnal hypoglycaemia was significantly less frequent with degludec [relative rate 0.42 (95% CI 0.250.69)], and overall hypoglycaemia numerically less frequent [relative rate 0.72 (95% CI 0.521.00)]. After 16 weeks, a significant improvement in Short Form 36 Health Survey mental component score of +3.01 (95% CI 0.325.70) was obtained for degludec against glargine, attributable to significant differences in the social functioning [+8.04 (95% CI 1.8914.18)] and mental health domains [+2.46 (95% CI 0.104.82)]. For mental component score, Cohens effect size was 0.42, indicating a small-to-medium clinically meaningful difference. The physical component score [+0.66 (95% CI 2.30 to 3.62)] and remaining domains were not significantly different between degludec and glargine.

    Conclusions: In the context of comparable overall glycaemic control with glargine, degludec improved mental well-being as measured using the mental component score of the Short Form 36 Health Survey. The improvements in overall mental component score and the underlying social functioning and mental health domains with degludec compared with glargine may relate to the observed reduction in hypoglycaemic events.

  • 10.
    Jansson, Stefan P. O.
    et al.
    Örebro University, School of Medicine, Örebro University, Sweden. Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden; Family Medicine Research Centre, Örebro County Council, Örebro, Sweden.
    Andersson, D. K. G.
    Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
    Svärdsudd, K.
    Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
    Mortality and cardiovascular disease outcomes among 740 patients with new-onset Type 2 diabetes detected by screening or clinically diagnosed in general practice2016In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 33, no 3, p. 324-331Article in journal (Refereed)
    Abstract [en]

    Aim: Screening for Type 2 diabetes among people at high risk is recommended by many organizations. The aim of this study was to analyse all-cause mortality and cardiovascular disease (CVD) outcomes in patients with Type 2 diabetes detected by screening or diagnosed clinically.

    Methods: A diabetes register was established at the primary healthcare centre in Laxa, Sweden beginning in 1972. The register was based on data from clinical records with information on medical treatment and laboratory data, as well as all-cause mortality, CVD, myocardial infarction and stroke events from national registers until 31 December 2013. A total of 740 patients with new-onset Type 2 diabetes were registered between 1972 and 2001. In addition, an opportunistic diabetes-screening programme involving people aged 35-79 years started in 1983 and was repeated onwards in 5-year cycles.

    Results: Baseline characteristics showed a significantly higher CVD risk, mainly depending on more prevalent CVD events in the screened compared with the clinically detected group (propensity score 0.59 vs. 0.46, P < 0.0001). After mean follow-up periods of 12.9 and 13.6 years for screening detected vs. clinically detected patients, respectively, hazard ratios were as follows: all-cause mortality, 0.99 (P = 0.89); CVD, 1.17 (P = 0.10); myocardial infarction, 1.08 (P = 0.49); and stroke, 1.03 (P = 0.83).

    Conclusions: No reduction in total mortality or CVD outcomes was found in patients with Type 2 diabetes that was detected by screening compared with those diagnosed clinically.

  • 11.
    Jansson, Stefan P. O.
    et al.
    Örebro University Hospital. Family Medicine Research Centre.
    Andersson, Dan K. G
    Department of Public Health and Caring Sciences, Family Medicine, Uppsala University, Uppsala, Sweden; Department of Preventive Medicine Section, Uppsala University, Uppsala, Sweden.
    Svärdsudd, Kurt F.
    Department of Public Health and Caring Sciences, Family Medicine, Uppsala University, Uppsala, Sweden; Department of Preventive Medicine Section, Uppsala University, Uppsala, Sweden.
    Effects of fasting blood glucose, diabetes treatment, blood pressure and anti-hypertension treatment on cardiovascular disease incidence: a 30-year follow-up study of 740 incident patients with Type 2 diabetes2013In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 30, no 3, p. 349-357Article in journal (Refereed)
    Abstract [en]

    Aims To analyse the effects of hyperglycaemia and blood pressure, diabetes and anti-hypertension treatment on total and various types of cardiovascular disease incidence in patients with Type 2 diabetes followed for 30years.

    Methods A total of 740 incident patients with Type 2 diabetes were registered at the Laxa Primary Health Care Centre, Sweden between 1972 and 2001. Information on systolic, diastolic, and mean arterial blood pressure, mean fasting blood glucose, type of diabetes and anti-hypertension treatment was obtained from the patient records, and information on cardiovascular disease, myocardial infarction and stroke events from National Registers.

    Results During the follow-up period the cumulative incidence of cardiovascular disease increased significantly with male sex (HR 1.52, 95% CI 1.251.85), age (HR 1.05, 95% CI 1.041.07), year of diabetes onset (HR 1.03, 95% CI 1.011.05), BMI, (HR 1.04, 95% CI 1.021.07), mean arterial blood pressure (HR 1.04, 95% CI 1.021.05) and number of previous cardiovascular disease events (HR 1.15, 95% CI 1.101.21), and decreased significantly with sulfonylurea treatment (HR 0.64, 95% CI 0.490.84), insulin (HR 0.57, 95% CI 0.330.98) and calcium channel blocker treatment (HR, 0.69, 95% CI 0.480.99). Cumulative incidence of myocardial infarction increased significantly with male sex, age, BMI, mean arterial blood pressure, number of previous myocardial infarction events and diuretic treatment, and decreased with metformin treatment. Cumulative incidence of stroke increased with age, year of diabetes onset, mean arterial blood pressure, and previous number of stroke events.

    Conclusions Cumulative cardiovascular disease, myocardial infarction and incidence of stroke increased with number of previous events and presence of hypertension and decreased with pharmacological anti-diabetic treatment and, to a lesser extent, with anti-hypertension treatment.

  • 12.
    Jansson, Stefan P. O.
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Family Medicine Research Centre, Region Örebro County, Örebro, Sweden.
    Fall, Katja
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Brus, O.
    Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Magnuson, A.
    Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Wändell, P.
    Department of Neurobiology, Care Sciences and Society, Unit of Family Medicine, Karolinska Institutet, Huddinge, Sweden.
    Östgren, C. J.
    Division of Community Medicine, Department of Medicine and Health Sciences, Faculty of Health Sciences, Linköping University, Linköping, Sweden; Department of Local Care West, County Council of Östergötland, Linköping, Sweden.
    Rolandsson, O.
    Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden.
    Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden2015In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 32, no 10, p. 1319-1328Article in journal (Refereed)
    Abstract [en]

    Aim: To investigate the changes in prevalence and incidence of pharmacologically and non-pharmacologically treated diabetes in Sweden during 2005 to 2013.

    Methods: We obtained data on gender, date of birth and pharmacologically and non-pharmacologically treated diabetes from national registers for all Swedish residents.

    Results: During the study period a total of 240 871 new cases of pharmacologically treated diabetes was found. The age-standardized incidence during the follow-up was 4.34 and 3.16 per 1000 individuals in men and women, respectively. A decreasing time trend in incidence for men of 0.6% per year (0.994, 95% CI 0.989-0.999) and for women of 0.7% per year (0.993, 95% CI 0.986-0.999) was observed. The age-standardized prevalence increased from 41.9 and 29.9 per 1000 in 2005/2006 to 50.8 and 34.6 in 2012/2013 in men and women, respectively. This corresponds to an annually increasing time trend for both men (1.024, 95% CI 1.022-1.027) and women (1.019, 95% CI 1.016-1.021). The total age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes (2012) was 46.9 per 1000 (55.6 for men and 38.8 for women). This corresponds to an annually increasing time trend (2010-2012) for both men (1.017, 95% CI 1.013-1.021) and women (1.012, 95% CI 1.008-1.016).

    Conclusions: The prevalence of pharmacologically treated diabetes increased moderately during 8 years of follow-up, while the incidence decreased modestly. This is in contrast to the results reported by most other studies. The total prevalence of diabetes (both pharmacologically and non-pharmacologically treated) in Sweden is relatively low, from a global viewpoint.

  • 13.
    Jansson, Stefan P. O.
    et al.
    Örebro University, School of Medical Sciences. University Health Care Research Center, Region Örebro County, Örebro, Sweden.
    Fall, Katja
    Örebro University, School of Medical Sciences.
    Brus, O.
    Magnuson, A.
    Wändell, P.
    Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.
    Östgren, C. J.
    Division of Community Medicine, Department of Medicine and Health Sciences, Linköping University, Linköping, Sweden; Department of Local Care West, County Council of Östergötland, Linköping, Sweden.
    Rolandsson, O.
    Department of Public Health and Clinical Medicine, Umea University, Umeå, Sweden.
    Response to Carlsson et al.: Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden2016In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 33, no 8, p. 1150-1152Article in journal (Refereed)
  • 14.
    Jansson, Stefan P. O.
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Family Medicine Research Centre, Örebro County Council, Örebro, Sweden; Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine Section, Uppsala University, Uppsala, Sweden.
    Svärdsudd, K.
    Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine Section, Uppsala University, Uppsala, Sweden.
    Andersson, D. K. G.
    Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine Section, Uppsala University, Uppsala, Sweden.
    Effects of fasting blood glucose levels and blood pressure and treatment of diabetes and hypertension on the incidence of cardiovascular disease: a study of 740 patients with incident Type 2 diabetes with up to 30 years' follow-up2014In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 31, no 9, p. 1055-1063Article in journal (Refereed)
    Abstract [en]

    Aims: To analyse the effects of hyperglycaemia and hypertension and treatment of diabetes and hypertension on cardiovascular disease incidence in patients with Type 2 diabetes with up to 30 years of follow-up.

    Methods: A total of 740 patients with incident Type 2 diabetes were registered at the Laxa Primary Health Care Centre, Sweden between 1972 and 2001. Annual data on mean fasting blood glucose, systolic, diastolic and mean arterial blood pressure, and type of diabetes and hypertension treatment were obtained from patient records, and information on cardiovascular disease, myocardial infarction and stroke events was obtained from national registers.

    Results: During the follow-up period, cumulative cardiovascular disease incidence increased significantly with male sex (hazard ratio 1.48, 95% CI 1.21-1.82), number of previous cardiovascular disease events (hazard ratio 1.13, 95% CI 1.08-1.18), age, per year (HR 1.05, 95% CI 1.04-1.07), mean fasting blood glucose, per mmol/l (hazard ratio 1.05, 95% CI 1.00-1.10) BMI (hazard ratio 1.04, 95% CI 1.01-1.06), mean arterial blood pressure, per mmHg (hazard ratio 1.02, 95% CI 1.01-1.03), and decreased significantly with metformin treatment (hazard ratio 0.58, 95% CI 0.38-0.90) and sulfonylurea (hazard ratio 0.73, 95% CI 0.55-0.97). Cumulative myocardial infarction incidence increased significantly with male sex, number of previous myocardial infarction events, mean fasting blood glucose level, BMI, age and mean arterial blood pressure, and decreased with metformin treatment. Cumulative stroke incidence increased with number of previous stroke events, age and mean arterial blood pressure.

    Conclusions: The cumulative incidence of cardiovascular disease and myocardial infarction increased with number of previous events and presence of hyperglycaemia and hypertension and decreased with pharmacological treatment of diabetes. A higher number of previous stroke events increased the cumulative incidence of stroke but no protective effect of pharmacological treatment was observed.

  • 15.
    Kaas, A.
    et al.
    Department of Paediatrics, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.
    Pfleger, C.
    Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research, Heinrich-Heine University, Düsseldorf, Germany.
    Kharagjitsingh, A. V.
    Department of Medical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands.
    Schloot, N .C.
    Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research, Heinrich-Heine University, Düsseldorf, Germany; Medical Faculty, Department of Metabolic Diseases, University of Düsseldorf, Düsseldorf, Germany .
    Hansen, L.
    Department of Paediatrics, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.
    Buschard, K.
    Bartholin Institute, Rigshospitalet, Copenhagen, Denmark.
    Koeleman, B. P. C.
    Department of Medical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands.
    Roep, B. O.
    Department of Immunohaematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands.
    Mortensen, H. B.
    Department of Paediatrics, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.
    Alizadeh, B. Z.
    Department of Medical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands.
    Association between age, IL-10, IFN gamma, stimulated C-peptide and disease progression in children with newly diagnosed Type 1 diabetes2012In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 29, no 6, p. 734-741Article in journal (Refereed)
    Abstract [en]

    AIMS: The relation of disease progression and age, serum interleukin 10 (IL-10) and interferon gamma (IFNγ) and their genetic correlates were studied in paediatric patients with newly diagnosed Type 1 diabetes.

    METHODS: Two hundred and twenty-seven patients from the Hvidoere Study Group were classified in four different progression groups as assessed by change in stimulated C-peptide from 1 to 6 months. CA repeat variants of the IL-10 and IFNγ gene were genotyped and serum levels of IL-10 and IFNγ were measured at 1, 6 and 12 months.

    RESULTS: IL-10 decreased (P < 0.001) by 7.7% (1 month), 10.4% (6 months) and 8.6% (12 months) per year increase in age of child, while a twofold higher C-peptide concentration at 1 month (p = 0.06), 6 months (P = 0.0003) and 12 months (P = 0.02) was associated with 9.7%, 18.6% and 9.7% lower IL-10 levels, independent of each other. IL-10 concentrations did not associate with the disease progression groups. By contrast, IFNγ concentrations differed between the four progression groups at 6 and 12 months (P = 0.02 and P = 0.01, respectively); patients with rapid progressing disease had the highest levels at both time points. Distribution of IL-10 and IFNγ genotypes was equal among patients from the progression groups.

    CONCLUSION: IL-10 serum levels associate inversely with age and C-peptide. As age and C-peptide also associate, a triangular association is proposed. Genetic influence on IL-10 production seems to be masked by distinct disease mechanisms. Increased serum IFNγ concentrations associate with rapid disease progression. Functional genetic variants do not associate with a single progression pattern group, implying that disease processes override genetically predisposed cytokine production.

  • 16.
    Kølendorf, K.
    et al.
    Diabetes Centre, Roskilde Amtssygehus, Køge, Denmark.
    Ross, G. P.
    The Diabetes Centre, Royal Prince Alfred Hospital, Sydney, Australia.
    Pavlic-Renar, I.
    Outpatient Diabetes Department, Vuk Vrhovac Institute, Zagreb, Croatia.
    Perriello, G.
    Department of Internal Medicine, University of Perugia, Perugia, Italy.
    Philotheou, A.
    Endocrine Diabetes Unit, University of Cape Town, Cape Town, South Africa.
    Jendle, Johan
    Department of Internal Medicine, Trelleborg Hospital, Trelleborg, Sweden.
    Gall, M.-A.
    Medical Development, NovoNordisk A/S, Bagsvaerd, Denmark.
    Heller, S. R.
    Clinical Sciences Centre, Northern General Hospital, Sheffield, UK.
    Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes2006In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 23, no 7, p. 729-735Article in journal (Refereed)
    Abstract [en]

    AIMS: Hypoglycaemia remains a major barrier preventing optimal glycaemic control in Type 1 diabetes due to the limitations of conventional insulin preparations. We investigated whether basal-bolus therapy with insulin detemir (detemir), a new soluble basal insulin analogue, was more effective in reducing the risk of hypoglycaemia compared with NPH insulin (NPH).

    METHODS: In this multinational, open-label, cross-over trial, 130 individuals with Type 1 diabetes received detemir and NPH twice daily in a randomized order in combination with premeal insulin aspart (IAsp) during two 16-week treatment periods. Risk of hypoglycaemia was based on self-measured plasma glucose (SMPG) and self-reported episodes during the last 10 weeks of each period.

    RESULTS: Risk of nocturnal and overall hypoglycaemia was, respectively, 50% and 18% lower with detemir than with NPH (P < 0.001). A total of 19 severe hypoglycaemic episodes occurred during treatment with detemir compared with 33 with NPH (NS). HbA(1c) decreased by 0.3% point with both treatments and was comparable at 7.6% (+/- sem 0.06%, 95% confidence interval -0.106, 0.108) after 16 weeks with similar doses of basal insulin. Within-person variation in mean plasma glucose was lower with detemir than with NPH (sd 3.00 vs. 3.33, P < 0.001), as was prebreakfast SMPG (P < 0.0001).

    CONCLUSIONS: Detemir was associated with a significantly lower risk of hypoglycaemia compared with NPH at similar HbA1c when used in combination with mealtime IAsp. The more consistent plasma glucose levels observed with detemir may allow people to aim for tighter glycaemic control without an increased risk of hypoglycaemia.

  • 17.
    Linden, Karoline
    et al.
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care, University of Gothenburg, Gothenburg, Sweden.
    Berg, Marie
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care, University of Gothenburg, Gothenburg, Sweden.
    Adolfsson, Annsofie
    Örebro University, School of Health Sciences. Faculty of Health Sciences, Department of Nursing Science, University College of Southeast Norway, Kongsberg, Norway.
    Sparud Lundin, Carina
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care, University of Gothenburg, Gothenburg, Sweden.
    Person-centred web-based support in pregnancy and early motherhood for women with Type 1 Diabetes Mellitus: a randomized controlled trial2018In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 5, no 2, p. 232-241Article in journal (Refereed)
    Abstract [en]

    Aims: To report results from and explore use of a multicentre, parallel-group, unblinded, randomized controlled trial testing the effectiveness in terms of well-being and diabetes management of a person-centred, web-based support programme for women with Type 1 diabetes, in pregnancy and postpartum.

    Methods: Between 2011 and 2014, 174 pregnant women with Type 1 diabetes were randomly allocated (1:1) to web-based support and standard care (intervention group, n=83), or standard care (control group, n=91). The web-based support consisted of evidence-based information; a self-care diary for monitoring of daily activities; and peer support in a discussion forum. The primary outcomes (mean difference, measured at 6 months after childbirth) were well-being and diabetes management.

    Results: No differences were found with regard to the primary outcome measure scores for general well-being [1.04 (95% CI -1.28 to 3.37); P= 0.68] and self-efficacy of diabetes management [0.076 (95% CI -0.123 to 0.275); P= 0.75], after adjustment for baseline differences in the insulin administration method, nor with regard to the secondary outcome measures.

    Conclusions: At 6 months after childbirth, the web-based support plus standard care was not superior to standard care in terms of general well-being or self-efficacy of diabetes management. This might be explained by the low number of participants who had a high activity level. Few simultaneously active participants in the web-based programme and stressors in motherhood and diabetes postpartum were the main barriers to its use. Further intervention studies that offer web-based support are needed, with lessons learned from the present study.

  • 18.
    Lodefalk, Maria
    et al.
    Department of Paediatric Diabetology and Endocrinology, Astrid Lindgren Children’s Hospital, Karolinska University Hospital, Stockholm; Department of Paediatrics, Örebro University Hospital, Örebro.
    Åman, Jan
    Department of Paediatric Diabetology and Endocrinology, Astrid Lindgren Children’s Hospital, Karolinska University Hospital, Stockholm; Department of Paediatrics, Örebro University Hospital, Örebro.
    Food habits, energy and nutrient intake in adolescents with Type 1 diabetes mellitus2006In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 23, no 11, p. 1225-1232Article in journal (Refereed)
    Abstract [en]

    AIMS: The aims were to describe the food habits of adolescents with Type 1 diabetes (Type 1 DM) and to compare them with healthy control subjects; to describe the distribution of energy-providing nutrients in patients and compare it with current recommendations and previous reports; and finally, to investigate associations between dietary intake and glycaemic control. METHODS: One hundred and seventy-four adolescents with Type 1 DM and 160 age- and sex-matched healthy control subjects completed a validated food frequency questionnaire, and 38 randomly chosen patients completed a prospective 4-day food record. RESULTS: Patients ate more regularly, and more often ate fruit and fruit juice, potatoes and root vegetables, meat, fish, egg, offal and sugar-free sweets than control subjects. Control subjects more often ate ordinary sweets and snacks. Patients chose coarse rye bread and dairy products with less fat to a greater extent than control subjects. Patients were heavier than control subjects. The intake of saturated fat was higher in patients compared with recommendations and, for boys with diabetes, the intake of protein was higher than recommended. Patients with poorer glycaemic control ate vegetables, fruit and fish less often than patients with better control. CONCLUSIONS: The food habits of adolescents with Type 1 DM were healthier than those of control subjects. The intake of energy-providing nutrients was in line with current recommendations and showed improvements compared with previous reports, with the exception of fibre intake. The association between dietary intake and glycaemic control needs further investigation in prospective studies.

  • 19.
    Lodefalk, Maria
    et al.
    Örebro University, School of Health and Medical Sciences. Paediatric Endocrinology and Diabetes Unit, Department of Woman and Child Health, Karolinska Institute, Stockholm; Department of Paediatrics, Örebro University Hospital, Örebro, Sweden.
    Åman, Jan
    Örebro University, School of Health and Medical Sciences. Departm ent of Paediatrics, Örebro University Hospital, Örebro, Sweden.
    Bang, P.
    Paediatric Endocrinology and Diabetes Unit, Department of Woman and Child Health, Karolinska Institute, Stockholm.
    Effects of fat supplementation on glycaemic response and gastric emptying in adolescents with Type 1 diabetes2008In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 25, no 9, p. 1030-1035Article in journal (Refereed)
    Abstract [en]

    AIMS: To compare the glycaemic response to meals with different fat content in adolescents with Type 1 diabetes mellitus (T1DM) and to investigate associations with gastric emptying.

    METHODS: In this randomized, cross-over study, paired results were obtained from seven adolescents with T1DM who ingested on different days two meals with the same carbohydrate and protein content, but different fat and energy content (2 and 38 g fat, 320 and 640 kcal, respectively). Paracetamol was mixed into the meals and gastric emptying was estimated by the paracetamol absorption method. All subjects were normoglycaemic and given 7 IU insulin aspart at commencement of ingestion. Postprandial blood samples were taken during 4 h.

    RESULTS: The areas under the curves for plasma glucose and serum paracetamol concentrations were larger after the low-fat than after the high-fat meal during the first 2 h (P = 0.047 and P = 0.041, respectively). The difference between meals in time-to-peak in glucose and paracetamol concentrations did not reach statistical significance (high-fat vs. low-fat meal: 210 min (120-240) vs. 120 min (50-240), P = 0.080 and 120 min (75-180) vs. 60 min (60-120), P = 0.051, respectively). Changes in glucose concentrations correlated with simultaneous changes in paracetamol concentrations (P < 0.001).

    CONCLUSIONS: For the first time, we have shown that the initial glycaemic response is reduced after a meal with higher compared with a meal with lower fat content in adolescents with T1DM given a rapid-acting insulin analogue preprandially. The type and dose of preprandial insulin may need adjustment to the fat content of the meal to reach postprandial normoglycaemia.

  • 20.
    Persson, M.
    et al.
    Clinical Epidemiological Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
    Fadl, Helena
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Obstetrics and Gynecology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Perinatal outcome in relation to fetal sex in offspring to mothers with pre-gestational and gestational diabetes-a population-based study2014In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 31, no 9, p. 1047-1054Article in journal (Refereed)
    Abstract [en]

    Aim: The objective of the present study was to investigate if perinatal outcome differs with fetal sex in pregnancies with maternal Type 1 diabetes, Type 2 diabetes or gestational diabetes.

    Methods: This was a population-based cohort study, with data from the Medical Birth Registry in Sweden throughout the period 1998-2007. Singleton pregnancies with maternal Type 1 diabetes (n = 4092), Type 2 diabetes (n = 412) and gestational diabetes (n = 8602) were identified based on the International Classification of Diseases, 10th edition code. For comparison, 905 565 pregnancies without diabetes were included. The primary outcome was a composite outcome, consisting of any of the following diagnoses: perinatal mortality rate, major malformation, preterm delivery, acute respiratory disorders and neonatal hypoglycaemia. Logistic regression was used to obtain odds ratios for adverse outcomes in male offspring within the diabetic and reference cohorts, respectively.

    Results: In pregnancies with diabetes, maternal characteristics did not differ with fetal sex, except for a higher rate of Caesarean delivery in male offspring of women with Type 1 diabetes. Male infants to mothers with Type 1 diabetes and gestational diabetes had significantly increased odds of respiratory disorders [adjusted odds ratio (confidence interval) Type 1 diabetes: 1.50 (1.12-2.02); gestational diabetes: 1.81 (1.27-2.57)]. Male infants to mothers with gestational diabetes also had significantly increased odds of major malformations [adjusted odds ratio: 1.44 (1.07-1.93)]. In offspring of mothers with Type 2 diabetes, odds ratios of most outcomes were higher in male infants; however, not significantly different from female infants. In pregnancies without diabetes, male infants had significantly higher odds of all adverse outcomes, except perinatal mortality rate.

    Conclusion: The risk of adverse perinatal outcome in offspring of mothers with Type 1 diabetes and gestational diabetes did not differ by sex, except for a higher risk in male infants for respiratory disorders. The risk of major malformations was also significantly increased in male offspring to mothers with gestational diabetes. In offspring of mothers with Type 2 diabetes, no significant differences between sexes were found.

  • 21.
    Roze, S.
    et al.
    HEVA HEOR, Lyon, France.
    Saunders, R.
    Ossian Health Economics and Communications, Basel, Denmark .
    Brandt, A. -S
    Medtronic Danmark A/S, Copenhagen, Denmark .
    de Portu, S.
    Medtronic International Trading Sarl, Tolochenaz, Switzerland.
    Papo, N. L.
    Medtronic International Trading Sarl, Tolochenaz, Sweden .
    Jendle, Johan
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Endocrine and Diabetes Centre, Karlstad Hospital, Karlstad, Sweden .
    Health-economic analysis of real-time continuous glucose monitoring in people with Type 1 diabetes2015In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 32, no 5, p. 618-626Article in journal (Refereed)
    Abstract [en]

    Aim: To evaluate the clinical benefits and cost-effectiveness of the sensor-augmented pump compared with self-monitoring of plasma glucose plus continuous subcutaneous insulin infusion in people with Type 1 diabetes.

    Methods: The CORE Diabetes Model was used to simulate disease progression in a cohort of people with baseline characteristics taken from a published meta-analysis. Direct and indirect costs for 2010-2011 were calculated from a societal payer perspective, with cost-effectiveness calculated over the patient's lifetime. Discount rates of 3% per annum were applied to the costs and the clinical outcomes.

    Results: Use of the sensor-augmented pump was associated with an increase in mean discounted, quality-adjusted life expectancy of 0.76 quality-adjusted life years compared with continuous subcutaneous insulin infusion (13.050.12 quality-adjusted life years vs 12.290.12 quality-adjusted life years, respectively). Undiscounted life expectancy increased by 1.03years for the sensor-augmented pump compared with continuous subcutaneous insulin infusion. In addition, the onset of complications was delayed (by a mean of 1.15years) with use of the sensor-augmented pump. This analysis resulted in an incremental cost-effectiveness ratio of 367,571 SEK per quality-adjusted life year gained with the sensor-augmented pump. The additional treatment costs related to the use of the sensor-augmented pump were partially offset by the savings attributable to the reduction in diabetes-related complications and the lower frequency of self-monitoring of plasma glucose.

    Conclusions: Analysis using the CORE Diabetes Model showed that improvements in glycaemic control associated with sensor-augmented pump use led to a reduced incidence of diabetes-related complications and a longer life expectancy. Use of the sensor-augmented pump was associated with an incremental cost-effectiveness ratio of 367,571 SEK per quality-adjusted life year gained, which is likely to represent good value for money in the treatment of Type 1 diabetes in Sweden.

    What's new? This study builds on a recent meta-analysis to provide further insights into the clinical and safety aspects of real-time continuous glucose monitoring. Simulations of disease progression show how these aspects translate into long-term patient benefits and healthcare costs. Simulations indicate that continuous glucose monitoring leads to later onset and reduced incidence of acute and long-term diabetes-related complications. The findings may have an important influence on informing treatment choices with respect to providing value both for patients and healthcare payers.

  • 22. Stenninger, Erik
    et al.
    Lindqvist, A.
    Åman, Jan
    Örebro University, School of Health and Medical Sciences.
    Östlund, I.
    Schvarcz, E.
    Continuous Subcutaneous Glucose Monitoring System in diabetic mothers during labour and postnatal glucose adaptation of their infants2008In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 25, no 4, p. 450-454Article in journal (Refereed)
    Abstract [en]

    Aims  To assess a new technique for continuous monitoring of glucose concentration during labour in diabetic mothers. A second objective was to study maternal glucose levels in relation to postnatal glucose adaptation and the need for intravenous (IV) glucose treatment in the newborn infant.

    Methods  Fifteen pregnant women with insulin-treated diabetes mellitus participated in this prospective pilot study. To measure their glucose control during labour we used the Continuous Subcutaneous Glucose Monitoring System (CGMS; Medtronic, Minneapolis, MN, USA) to calculate the mean glucose concentration and the area under the curve (AUC) in the last 120 min before delivery. All infants of these women were transferred to the neonatal care unit for early oral feeding and blood glucose measurements up to 14 h after delivery. Infants received IV glucose if blood glucose values were repeatedly < 2.2 mmol/l.

    Results  All women coped well with the CGMS monitoring. AUC 0–120 min before delivery, mean glucose concentration 0–120 min before delivery and cord plasma insulin level were all significantly associated with the need for IV glucose in the newborn children.

    Conclusions  In this study we found an association between maternal glucose concentrations during labour and postnatal glucose adaptation and need for IV glucose treatment in the infants. Online monitoring of glucose levels during delivery might help us to achieve maternal normoglycaemia and further reduce the risk of postnatal hypoglycaemia in the offspring.

  • 23.
    Söderström, Ulf
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Centre for Clinical Research Sörmland, Uppsala University, Uppsala, Sweden; Department of Pediatrics, Mälarsjukhuset Hospital, Eskilstuna, Sweden.
    Samuelsson, Ulf
    Division of Paediatrics, Department of Molecular and Clinical Medicine, Linköping University, Linköping, Sweden; Department of Pediatrics, University Hospital in Linköping, Linköping, Sweden.
    Sahlqvist, Lotta
    Centre for Clinical Research Sörmland, Uppsala University, Uppsala, Sweden.
    Åman, Jan
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Department of Pediatrics, Örebro University Hospital, Örebro, Sweden.
    Impaired metabolic control and socio-demographic status in immigrant children at onset of type 1 diabetes2014In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 31, no 11, p. 1418-1423Article in journal (Refereed)
    Abstract [en]

    Aim: The aim of the present study was to compare clinical and socio-demographic conditions at the onset of Type1 diabetes in children born to immigrant families and children born to Swedish families, and to assess whether those conditions had an impact on metabolic status.

    Methods and design: This was an observational nationwide population-based matched cohort study on prospectively recorded registry data of all children with diabetes in Sweden and their families during 2000-2010. Out of a total of 13415 children from the Swedish Childhood Diabetes Registry (SWEDIABKIDS), 879 children born to immigrant parents were collected. To these we added 2627 children with Swedish-born parents, matched for gender, age and year of onset of Type1 diabetes.

    Results: The proportion of low capillary pH (<7.30) at onset was higher in the immigrant cohort [25.8% vs. 16.4% in the Swedish cohort (P<0.001)]. HbA(1c) was also higher [95mmol/mol (10.8%) vs. 88mmol/mol (10.2%), respectively (P<0.001)]. In a logistic regression model with low pH as the dependent variable, we were unable to reveal any significant association to socio-demographic factors, but the odds ratio for HbA(1c) was 0.983 (95%CI 0.976-0.991) and for plasma glucose was 0.953 (95%CI 0.933-0.973).

    Conclusion: Children born to immigrant parents have lower capillary pH and higher HbA(1c) at diabetes onset. Immigrant families harbour lower socio-demographic living conditions, but this fact does not seem to influence the inferior metabolic condition at diabetes onset.

  • 24.
    Valentine, W. J.
    et al.
    Ossian Health Economics and Communications GmbH, Basel, Switzerland.
    Jendle, Johan
    Örebro University, School of Medical Sciences.
    Saraheimo, M.
    Folkhälsan Research Centre, Helsinki University, Helsinki, Finland.
    Thorsteinsson, B.
    Department of Cardiology and Endocrinology, Hillerød Hospital, Hillerød, Denmark; Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
    Pollock, R. F.
    Ossian Health Economics and Communications GmbH, Basel, Switzerland.
    Lammert, M.
    Novo Nordisk Scandinavia, Copenhagen, Denmark.
    Evaluating the cost-effectiveness of reduced mild hypoglycaemia in subjects with Type 1 diabetes treated with insulin detemir or NPH insulin in Denmark, Sweden, Finland and the Netherlands2012In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 29, no 3, p. 303-312Article in journal (Refereed)
    Abstract [en]

    AIMS: To estimate short-term cost-effectiveness of insulin detemir vs. NPH insulin based on the incidence of mild hypoglycaemia in subjects with Type 1 diabetes in Denmark, Sweden, Finland and the Netherlands.

    METHODS: A model was developed to evaluate cost-effectiveness based on mild (self-treated) hypoglycaemia and pharmacy costs over 1 year. Published rates of mild hypoglycaemia were used for NPH insulin and insulin detemir. Effectiveness was calculated in terms of quality-adjusted life expectancy. Pharmacy costs were accounted using published prices and defined daily doses for both insulins. Costs were expressed in 2010 euros (€).

    RESULTS: Treatment with insulin detemir was associated with fewer mild hypoglycaemic events than NPH insulin (mean rates of 26.3 vs. 35.5 events per person-year), leading to an improvement in mean quality-adjusted life expectancy of approximately 0.019 (0.030) quality-adjusted life years (standard deviation). Annual costs were € 573.55 (110.42) vs. € 332.76 (62.18) in Denmark for insulin detemir and NPH insulin, respectively. These values were € 545.79 (106.54) vs. € 306.12 (57.78) in Sweden, € 720.10 (140.74) vs. € 408.73 (78.61) in Finland and € 584.01 (109.47) vs. € 359.60 (64.84) in the Netherlands. Incremental cost-effectiveness ratios were approximately € 12,644 (Denmark), € 12,612 (Sweden), € 16,568 (Finland) and € 12,216 (the Netherlands) per quality-adjusted life year gained for insulin detemir vs. NPH insulin.

    CONCLUSIONS: Insulin detemir is likely to be cost-effective vs. NPH insulin in subjects with Type 1 diabetes in Denmark, Sweden, Finland and the Netherlands. Increased pharmacy costs with insulin detemir should not be a barrier to therapy based on these findings.

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