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PubMed | University of Aalborg, University of Aarhus, University of Tromsø, Nordsjaellands University Hospital and Aarhus University Hospital
Type: Journal Article | Journal: Journal of diabetes science and technology | Year: 2015

The use of continuous glucose monitoring (CGM) in clinical decision making in diabetes could be limited by the inaccuracy of CGM data when compared to plasma glucose measurements. The aim of the present study is to investigate the impact of CGM numerical accuracy on the precision of diabetes treatment adjustments.CGM profiles with maximum 5-day duration from 12 patients with type 1 diabetes treated with a basal-bolus insulin regimen were processed by 2 CGM algorithms, with the accuracy of algorithm 2 being higher than the accuracy of algorithm 1, using the median absolute relative difference (MARD) as the measure of accuracy. During 2 separate and similar occasions over a 1-month interval, 3 clinicians reviewed the processed CGM profiles, and adjusted the dose level of basal and prandial insulin. The precision of the dosage adjustments were defined in terms of the interclinician agreement and the intraclinician reproducibility of the decisions. The Cohens kappa coefficient was used to assess the precision of the decisions. The study was based on retrospective and blind CGM data.For the interclinician agreement, in the first occasion, the kappa of algorithm 1 was .32, and that of algorithm 2 was .36. For the interclinician agreement, in the second occasion, the kappas of algorithms 1 and 2 were .17 and .22, respectively. For the intraclinician reproducibility of the decisions, the kappas of algorithm 1 were .35, .22, and .80 and the kappas of algorithm 2 were .44, .52, and .32, for the 3 clinicians, respectively. For the interclinician agreement, the relative kappa change from algorithm 1 to algorithm 2 was 86.06%, and for the intraclinician reproducibility, the relative kappa change from algorithm 1 to algorithm 2 was 53.99%.Results indicated that the accuracy of CGM algorithms might potentially affect the precision of the CGM-based insulin adjustments for type 1 diabetes patients. However, a larger study with several clinical centers, with higher number of clinicians and patients is required to validate the impact of CGM accuracy on decisions precision.


PubMed | University of Aarhus, Copenhagen University, Aarhus University Hospital, University of Southern Denmark and 2 more.
Type: | Journal: Diabetes research and clinical practice | Year: 2016

The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level.Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4mmol/mol) lower HbA1c.Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p<0.0001)).Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach.


PubMed | Holbaek Hospital, Steno Diabetes Center, The Danish Diabetes Academy, Nordsjaellands University Hospital and University of Aarhus
Type: Journal Article | Journal: Diabetologia | Year: 2016

Screening programmes for type 2 diabetes inevitably find more people at high risk of developing diabetes than people with undiagnosed prevalent diabetes. We describe the incidence of diabetes for risk groups according to advancement in a screening process.In 2001-2006, a diabetes screening programme based on the Danish diabetes risk score and measures of HbA1c and glucose was carried out in Danish general practices. The present study includes 13,249 individuals with low diabetes risk scores and 22,726 with high diabetes risk scores but no diabetes according to WHO 1999 criteria. Seven incremental levels of diabetes risk were defined and followed for incident diabetes recorded in the Danish National Diabetes Register until December 2012. For each group, cumulative diabetes incidence was calculated. Incidence rates and rate ratios were estimated by Poisson regression analyses.After 10 years of follow-up 1,164 new diabetes cases were registered. Incidence rates were 1.0, 4.2, 14.5, 28.8 and 52.6 per 1,000 person-years in individuals at low risk and in those with normal glucose tolerance, impaired fasting glucose, impaired glucose tolerance and one diabetic glucose value, respectively. For each step in the screening algorithm, the risk of developing diabetes was higher than in the previous step.The risk of developing clinical diabetes in people who screen negative for diabetes depends on the level of risk stratification at screening, even at lower risk levels. This risk increases markedly in the presence of impaired glucose regulation. These results can inform policy recommendations concerning prevention strategies following screening.


PubMed | Aarhus University Hospital, Rigshospitalet, Nordsjaellands University Hospital and Copenhagen University
Type: | Journal: Journal of diabetes and its complications | Year: 2016

Obstructive Sleep Apnoea (OSA) is frequent in patients with type 2 diabetes. The aim of this study is to evaluate prevalence of OSA in patients with type 1 diabetes.In a cross-sectional design, all patients with type 1 diabetes attending the outpatient clinic were offered screening for OSA for one night with the ApneaLink+ home-monitoring device. OSA was classified by the Apnoea-Hypopnea index (AHI; apnoeas/hypopneas per hour sleep). Symptoms of OSA were scored using the Epworth Sleepiness Score. Presence of autonomic neuropathy was evaluated by the Vagus device.A total of 200 of 518 eligible patients with type 1 diabetes (39%) participated (68% men; age 5215years (meanSD), diabetes duration 2414years and BMI 25.33.3kg/mThe prevalence of asymptomatic OSA is high in a cohort of patients with type 1 diabetes. Older age, overweight, and presence of nephropathy are associated with OSA.


PubMed | University of Padua, 3 Hyposafe and Nordsjaellands University Hospital
Type: Journal Article | Journal: Diabetes technology & therapeutics | Year: 2016

Hypoglycemic events in patients with type 1 diabetes (T1D) are associated with measurable electroencephalography (EEG) changes. Previous studies have, however, evaluated these changes on a single EEG channel level, whereas multivariate analysis of several EEG channels has been scarcely investigated. The aim of the present work is to use a coherence approach to quantitatively assess how hypoglycemia affects mutual connectivity of different brain areas.EEG multichannel data were obtained from 19 patients with T1D (58% males; mean age, 552.4 years; diabetes duration, 28.52.6 years; glycated hemoglobin, 8.00.2%) who underwent a hyperinsulinemic-hypoglycemic clamp study. The information partial directed coherence (iPDC) function was computed through multivariate autoregressive models during eu- and hypoglycemia in the theta and alpha bands.In passing from eu- to hypoglycemia, absolute values of the iPDC function tend to decrease in both bands in all combinations of the considered channels. In particular, the scalar indicator [Formula: see text], which summarizes iPDC information, significantly decreased (P<0.01) in 17 of 19 subjects: from T5-A1A2 to C3-A1A2 from O1-A1A2 to C4-A1A2 and from O2-A1A2 to Cz-A1A2 in the theta band and from O1-A1A2 to T4-A1A2 and from O1-A1A2 to C4-A1A2 in the alpha band.The coherence decrease measured by iPDC in passing from eu- to hypoglycemia is likely related to the progressive loss of cognitive function and altered cerebral activity in hypoglycemia. This result encourages further quantitative investigation of EEG changes in hypoglycemia and of how EEG acquisition and real-time processing can support hypoglycemia alert systems.


PubMed | Nordsjaellands University Hospital, Aleris Hamlet Hospital, Zealand University Hospital and Copenhagen University
Type: | Journal: The Journal of laryngology and otology | Year: 2016

Saliva composition may affect sialolithiasis formation; thus, this study compared the salivary inorganic composition of sialolithiasis patients with that of healthy controls, and determined whether salivary inorganic composition changes after sialolithiasis surgery.The study included 40 patients with sialolithiasis and 40 matched healthy controls. Patients were examined before and after sialolithiasis surgery; controls were examined once. Flow rate and the inorganic saliva composition in unstimulated whole saliva were assessed.Patients salivary flow prior to surgery was significantly lower compared to that of healthy controls, but equalised after surgery. Prior to surgery, patients saliva exhibited higher concentrations of calcium, magnesium, phosphorous compared to that of healthy controls. The concentration of most ions remained high after sialolithiasis surgery.Sialolithiasis patients had increased salivary concentrations of the ions that constitute the main inorganic phase of most sialoliths, and this may confer a risk for developing sialolithiasis.


PubMed | Nordsjaellands University Hospital and Radboud University Nijmegen
Type: Journal Article | Journal: Diabetic medicine : a journal of the British Diabetic Association | Year: 2016

To examine whether severe hypoglycaemia and impaired hypoglycaemic awareness, a principal predictor of severe hypoglycaemia, are associated with all-cause mortality or cardiovascular mortality in Type 1 diabetes mellitus.Mortality was recorded in two cohorts, one in Denmark (n = 269, follow-up 12 years) and one in the Netherlands (n = 482, follow-up 6.5 years). In both cohorts, awareness class was characterized and numbers of episodes of severe hypoglycaemia either during lifetime (Danish cohort) or during the preceding year (Dutch cohort) were recorded. In addition, episodes of severe hypoglycaemia were prospectively recorded every month for 1 year in the Danish cohort. Follow-up data regarding mortality were obtained through medical reports and registries (Danish cohort).All-cause mortality was 14% (n = 39) in the Danish and 4% (n = 20) in the Dutch cohort. In either cohort, neither presence of episodes with severe hypoglycaemia nor impaired hypoglycaemia awareness were associated with increased mortality in age-truncated Cox proportional hazard regression models. Variables associated with increased risk of all-cause mortality in both cohorts were evidence of macrovascular disease and reduced kidney function.Severe hypoglycaemia and hypoglycaemia unawareness are not associated with increased risk of all-cause or cardiovascular mortality in people with Type 1 diabetes mellitus.


Molsted S.,Nordsjaellands University Hospital | Andersen J.L.,Copenhagen University | Eidemak I.,Copenhagen University | Harrison A.P.,Copenhagen University | Jorgensen N.,Copenhagen University
BioMed Research International | Year: 2014

Background. We investigated serum testosterone and insulin-like growth factor 1 (IGF-1) levels' associations with muscle fibre size and resistance training in male dialysis patients. Methods. Male patients were included in a 16-week control period followed by 16 weeks of resistance training thrice weekly. Blood samples were obtained to analyse testosterone, luteinizing hormone (LH), IGF-1, and IGF-binding protein 3. Muscle fibres' size was analysed in biopsies from m. vastus lateralis. Results. The patients' testosterone levels were within the normal range at baseline (n=20) (19.5 (8.2-52.1) nmol/L versus 17.6 (16.1-18.0), resp.) whereas LH levels were higher (13.0 (5.5-82.8) U/L versus 4.3 (3.3-4.6), P<0.001, resp.). IGF-1 and IGF-binding protein 3 levels were higher in the patients compared with reference values (203 (59-590) ng/mL versus 151 (128-276), P=0.014, and 5045 (3370-9370) ng/mL versus 3244 (3020-3983), P<0.001, resp.). All hormone levels and muscle fibre size (n=12) remained stable throughout the study. Age-adjusted IGF-1 was associated with type 1 and 2 fibre sizes (P<0.05). Conclusion. Patients' total testosterone values were normal due to markedly increased LH values, which suggest a compensated primary insufficiency of the testosterone producing Leydig cell. Even though testosterone values were normal, resistance training was not associated with muscle hypertrophy. This trial is registered with ISRCTN72099857. © 2014 Stig Molsted et al.


PubMed | Zealand University Hospital, Statens Serum Institute, Nordsjaellands University Hospital, Copenhagen University and Private Ear
Type: | Journal: European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery | Year: 2016

Sialolithiasis is a frequent disorder affecting the salivary glands. The incidence rate (IR) has been reported to be 2.9-5.5 per 100,000 person-years, but all previous studies have been based on selected hospital data. In this study, we conducted a population-based study evaluating the IR of sialolithiasis and the IR variation according to age, gender and geography in Denmark. We included data from hospitals as well as from private ear, nose and throat (ENT) clinics. The study was based on registry data on all sialolithiasis cases in Denmark between 2003 and 2009 extracted from the Danish National Patient Registry (hospital cohort) and the Danish Regions Centre for Healthcare Statistics (private ENT clinic cohort). To validate the diagnosis, the proportion of visually confirmed cases was estimated based on patient records from subsamples of the two cohorts. The IR was 7.27 and 14.10 per 100,000 person-years based on visually confirmed cases only and on all cases, respectively. The highest IR was observed among 60- to 70-year-olds, in the North Denmark region and among females. In the validation subsamples, 35% of assumed sialoliths were visually confirmed in the private ENT clinic cohort and 59% in the hospital cohort. In this first population-based study of IR on sialolithiasis, we found a substantially higher IR. With respect to both visually confirmed cases and all cases, this is higher than previously reported from studies based on selected hospital data.


Molsted S.,Nordsjaellands University Hospital | Johnsen N.F.,University of Southern Denmark | Snorgaard O.,Hvidovre University Hospital
Diabetes Research and Clinical Practice | Year: 2014

Aims: In recent decades there has been an increased focus on non-pharmacological treatment of diabetes. The aim of this study was to investigate trends in leisure time physical activity (PA), smoking, body mass index (BMI), and alcohol consumption reported in 2000, 2005 and 2010 by Danish subjects with diabetes. Methods: Data comprised level of leisure time PA (inactive; moderate active; medium active; high active); smoking; BMI; and alcohol consumption, provided by The Danish Health and Morbidity Surveys. Participants older than 45 years with or without diabetes were included from cross-sectional analyses from 2000, 2005 and 2010. Results: In participants with diabetes, leisure time PA levels increased from 2000 to 2010: The percentage of those that were physically active increased from 53.5% to 78.2% (p<0.001; women) and from 67.8% to 79.1% (p=0.01; men). The prevalence of daily smokers was reduced from 27.2% to 16.4%, p=0.015, in women with diabetes. In men with diabetes, BMI increased from 27.2±4.0 to 28.6±5.1kgm-2, p=0.003, and men who exceeded the maximum recommendation for alcohol consumption increased from 9.4% to 19.0%, p=0.007. The leisure time PA level was reduced in participants with diabetes compared to participants without diabetes throughout the study. Conclusions: The percentage of physically active Danish participants older than 45 years with diabetes increased from 2000 to 2010, and the most beneficial trends in life style were observed among the women. These trends may have serious implications for cardiovascular risk in Danish patients with diabetes. © 2014 Elsevier Ireland Ltd.

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