This review finds that co-existing type 2 diabetes (T2D) and binge eating disorder (BED) may have significant individual and societal costs due to health and socioeconomic consequences. BED may worsen T2D management, potentially raising HbA1c levels and complicating treatment. ≤ 25% of T2D patients have BED, yet research and treatment are limited. Studies indicate that T2D treatment can trigger or worsen binge eating due to the focus on diet, exercise, and weight. Effective screening and tailored, evidence-based interventions are needed for this dual diagnosis to improve physical and psychosocial health outcomes.

Background: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear.Methods: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 x 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in com-bination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137). We present a detailed description of the methodology and statistical analysis of the clinical CIMT outcomes including a detailed description of tests of the assumptions behind the statistical analyses. The outcomes are quality of life (Short Form Health Survey (SF-36)), Diabetes Medication Satisfaction Questionnaire, and Insulin Treatment Satisfaction Questionnaire (assessed at entry and 18 months after randomisation) and cardiovascular outcomes including time to a composite of either myocardial infarction, stroke, peripheral amputation, coronary revascularisation, peripheral revascularisation, or death. Discussions: This statistical analysis plan ensure the highest possible quality of the subsequent post-hoc analyses.Trial registration: The protocol was approved by the Regional Committee on Biomedical Research Ethics (H -D-2007-112), the Danish Medicines Agency (EudraCT: 2007-006665-33 CIMT), and registered within ClinicalT rials.gov (NCT00657943, 8th of April 2008).

Background The indication for treatment of type 1 diabetes(T1D) with the sodium–glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin has been withdrawn in Europe likely because of concern for diabetic ketoacidosis (DKA). We calculated the incidence of DKA in people with T1D treated with SGLT2i in Denmark. Methods Clinical data from adults with T1D in Denmark were collected from nine outpatient clinics. Electronic health records made the search for DKA accurate. Results From a population of 10.500 we observed 134 people treated with SGLT2i over a total period of 222 patient-years. Of those 72% were female, mean age (SD) was 51.4 (13.6) years and median duration of treatment (median, IQR) with an SGLT2i were 12.0 (6.0–29.0) months. The incidence of DKA was zero%. Conclusion In 134 people with T1D treated with SGLT2i we found that none of the participants developed DKA during the treatment.

Background The implementation of an integrated electronic health record (EHR) system can potentially provide health care providers with support standardization of patient care, pathways, and workflows, as well as provide medical staff with decision support, easier access, and the same interface across features and subsystems. These potentials require an implementation process in which the expectations of the medical staff and the provider of the new system are aligned with respect to the medical staff’s knowledge and skills, as well as the interface and performance of the system. Awareness of the medical staff’s level of eHealth literacy may be a way of understanding and aligning these expectations and following the progression of the implementation process. Objective The objective of this study was to investigate how a newly developed and modified instrument measuring the medical staff’s eHealth literacy (staff eHealth Literacy Questionnaire [eHLQ]) can be used to inform the system provider and the health care organization in the implementation process and evaluate whether the medical staff’s perceptions of the ease of use change and how this may be related to their level of eHealth literacy. Methods A modified version of the eHLQ was distributed to the staff of a medical department in Denmark before and 3 months after the implementation of a new EHR system. The survey also included questions related to users’ perceived ease of use and their self-reported information technology skills. Results The mean age of the 194 participants before implementation was 43.1 (SD 12.4) years, and for the 198 participants after implementation, it was 42.3 (SD 12.5) years. After the implementation, the only difference compared with the preimplementation data was a small decrease in staff eHLQ5 (motivated to engage with digital services; unpaired 2-tailed t test; P=.009; effect size 0.267), and the values of the scales relating to the medical staff’s knowledge and skills (eHLQ1-3) were approximately ≥3 both before and after implementation. The range of scores was narrower after implementation, indicating that some of those with the lowest ability benefited from the training and new experiences with the EHR. There was an association between perceived ease of use and the 3 tested staff eHLQ scales, both before and after implementation. Conclusions The staff eHLQ may be a good candidate for monitoring the medical staff’s digital competence in and response to the implementation of new digital solutions. This may enable those responsible for the implementation to tailor efforts to the specific needs of segments of users and inform them if the process is not going according to plan with respect to the staff’s information technology–related knowledge and skills, trust in data security, motivation, and experience of a coherent system that suits their needs and supports the workflows and data availability.

A better understanding of explanatory factors for disease-specific health-related quality of life (HRQoL) in anorexia nervosa (AN) could help direct treatment providers to aspects of the most relevance for patient wellbeing and recovery. We aimed to investigate whether factors associated with HRQoL are the same for women with AN and normal-weight controls. The participants in this study were women with AN recruited from specialized eating disorder centers in Denmark and healthy, normal-weight controls invited via online social media. Participants completed online questionnaires on medical history, disease-specific HRQoL (Eating Disorders Quality of Life Scale, EDQLS) and generic HRQoL (SF-36), eating disorder symptomatology, depression, psychological wellbeing, and work and social adjustment. Questionnaires were fully completed by 211 women with AN (median age 21.7 years) and 199 controls (median age 23.9 years). Women with AN had poorer scores on all measures, i.e., worse HRQoL, psychological health, and work/social functioning. Eating disorder symptomatology affected EDQLS score in both groups, but poorer HRQoL in women with AN was also significantly associated with worse scores on bulimia, maturity fears, depression, vitality, and with older age. The factors investigated together explained 79% of the variance in EDQLS score. Management of disordered self-assessment and thought processes may be of particular importance to women with AN. Greater emphasis on these aspects alongside weight gain could enhance patient–clinician alliance and contribute to better treatment outcomes.

Background Treating patients with anorexia nervosa (AN) remains a major challenge. The choice between an inpatient or an outpatient care setting is an essential issue for the patients and for their relatives with major health economic implications. However, health services-related studies are lacking. The present study was a descriptive exploration of time-trends in treatment modes of patients with free and equal access to health services. Methods The study was based on a nationwide cohort of patients diagnosed for the first time with AN, each followed for 5 years in the registers covering the years 1994-2018. The per patient number of hospital admissions, cumulated number of days of hospitalization and number of outpatient visits during the first 5 years after initial diagnosis were considered. Results The cohort of patients with AN with at least 5 years of follow-up amounted toN= 7,505. A clear trend was observed in the per patient five-year cumulated number of inpatient days, decreasing by 6% per year after adjustment for age at diagnosis, parental mental diagnosis, and family income. The five-year number of hospital admissions after initial diagnosis decreased by 2% per year, while no trend was observed for outpatient visits. Conclusions The per patient number of hospitalizations and cumulated days of hospitalization during 5 years after diagnosis were reduced for patients initially diagnosed with AN while there was no change in the number of outpatient visits. The factors contributing to these changes of treatment modes over time are in need of further study.

Background: Health-related quality of life is severely affected in patients with anorexia nervosa due to both physical and psychological consequences of the disease, but it is still uncertain whether the same factors affect both clinical outcome and quality of life. It is also unknown whether there are differences between patients and controls in terms of self-reported physical, psychological and social well-being. Methods: Women with anorexia nervosa were recruited from specialized eating disorder centers in the five regions of Denmark. Healthy, normal-weight controls were invited via online social media to participate in the study. Six questionnaires including study characteristics, quality of life, eating disorder symptomatology, depression, work and social adjustment and psychological well-being were completed online by all participants. Results: 211 women with anorexia nervosa and 199 controls participated in the study. Women with anorexia nervosa reported significantly lower quality of life, both in terms of disease-specific HRQoL using the Eating Disorders Quality of Life Scale and on measures of general health, psychological well-being, and work functioning. Psychological and cognitive factors were highly associated with poor quality of life (p-value<0.05). Conclusions: Our findings suggest that attention to and management of disordered self-assessment and thought processes may be of special importance to women with anorexia nervosa and their families. It is possible that greater emphasis on such aspects alongside weight gain could enhance patient-clinician alliance and contribute to better treatment outcomes.

Glucagon-like receptor agonists (GLP-1RAs) are included in current national and international guidelines as second-line treatment especially in patients with type 2 diabetes and concomitant cardiovascular disease (CVD). First-generation GLP-1RAs were two- or once-daily injectables, but longer-acting GLP-1RAs have now been developed for once-weekly administration - e.g., exenatide ER, dulaglutide and semaglutide. With semaglutide, the same prolongation principle as designed in liraglutide is used (spacer and fatty acid chain). However, the similarity to endogenous human GLP-1 is well preserved, sharing 94% homology. It is administered with a simple device and without resuspension before use. The efficacy and safety of semaglutide have been investigated in an extensive clinical development program including more than 9,000 patients with type 2 diabetes. Semaglutide has been compared head-to-head with a dipeptidyl peptidase-4 (DPP4)-inhibitor, GLP-1RAs and basal insulin. Further head-to-head studies are awaiting that compare semaglutide against a sodium-dependent-glucose transporter-2 (SGLT2)-inhibitor. In these studies, semaglutide was found to provide significant and clinically relevant reductions in HbA1c, fasting plasma glucose (FPG), glucose excursions, body weight and blood pressure. The reduction in glycaemic parameters was more pronounced than that in the comparator GLP-1RAs. The rate of hypoglycemia is very low during treatment with semaglutide if not combined with sulphonylureas or insulin. A cardiovascular outcome trial (CVOT) was performed before the approval of semaglutide, at the request of legal authorities. Not only non-inferiority was confirmed, but also superiority compared with placebo used in a population of patients with type 2 diabetes and CVD treated with oral antihyperglycaemic drugs (OADs) and/or insulin with regard to the primary composite endpoint: death from cardiovascular (CV) causes, nonfatal myocardial infarction or nonfatal stroke. The safety of treatment with semaglutide in patients with type 2 diabetes has been extensively investigated. Overall, gastrointestinal side effects dominate, as observed with other GLP-1RAs, and was observed in the same range as for comparator GLP-1RAs. As observed with other GLP-1RAs, side effects such as nausea and vomiting diminished over time during continuous treatment. Regarding microvascular complications, an unexpected increase in diabetes-related retinopathy was observed in the CVOT; Semaglutide Unabated Sustainability in Treatment of Type 2 diabetes' [SUSTAIN 6]), but not in other studies. The reason for this increase is not finally elucidated, but may be due to a nonspecific effect of a rapid decrease in glycaemic parameters in patients with preexisting retinopathy with high HbA1c at the start of the treatment. There is currently a warning in the Summary of Product Characteristics (SmPC) for semaglutide concerning treatment in patients with preexisting retinopathy. Further studies are needed to clarify this.

Background Digitalization of health services ensures greater availability of services and improved contact to health professionals. To ensure high user adoption rates, we need to understand the indicators of use and nonuse. Traditionally, these have included classic sociodemographic variables such as age, sex, and educational level. Electronic health literacy (eHL) describes knowledge, skills, and experiences in the interaction with digital health services and technology. With our recent introduction of 2 new multidimensional instruments to measure eHL, the eHL questionnaire (eHLQ) and the eHL assessment (eHLA) toolkit, eHL provides a multifaceted approach to understand use and nonuse of digital health solutions in detail. Objective The aim of this study was to investigate how users and nonusers of digital services differ with respect to eHL, in a group of patients with regular contact to a hospital outpatient clinic. Furthermore, to examine how usage and nonusage, and eHL levels are associated with factors such as age, sex, educational level, and self-rated health. Methods Outpatients were asked to fill out a survey comprising items about usage of digital services, including digital contact to general practitioner (GP) and communication via the national health portal sundhed.dk, the eHLQ, and the eHLA toolkit, as well as items on age, sex, education, and self-rated health. In total, 246 patients completed the survey. A Mann-Whitney test was used to test for differences between users and nonusers of digital services. Correlation tests described correlations between eHL scales (eHEALSs) and age, education, and self-rated health. A significance level of .0071 was used to reject the null hypothesis in relation to the eHEALSs and usage of digital services. Results In total, 95.1% (234/246) of the participants used their personal digital ID (NemID), 57.7% (142/246) were in contact with their GPs electronically, and 54.0% (133/246) had used the national health portal (sundhed.dk) within the last 3 months. There were no differences between users and nonusers of sundhed.dk with respect to age, sex, educational level, and self-rated health. Users of NemID scored higher than nonusers in 6 of the 7 dimensions of eHLQ, the only one which did not differ was dimension 2: Understanding of health concepts and language. Sundhed.dk users had a higher score in all of the 7 dimensions except for dimension 4: Feel safe and in control. The eHLA toolkit showed that users of sundhed.dk and NemID had higher levels of eHL with regard to tools 2, 5, 6, and 7. Furthermore, users of sundhed.dk had higher levels of eHL with regard to tools 3 and 4. Conclusions Information about patients’ eHL may provide clinicians an understanding of patients’ reasons for not using digital health services, better than sociodemographic data or self-rated health.

Objectives: Family affects the perception of diabetes self-management in patients with diabetes. Family-related questionnaires have been used to assess family function, but the Brief Family Assessment Measure (Brief FAM-III) has not been used previously in a diabetes population. We aimed to determine whether the family function is associated with glycated hemoglobin levels and quality of life as potential predictors of diabetes self-management. Methods: An exploratory study of patients with type 2 diabetes and incipient complications and their relatives using the Brief FAM-III, a self-report questionnaire comprising 3 scales assessing family function according to different perspectives: a general score, a dyadic relationship score and a self-rating score. Results: We included 127 patients: 72.4% males, mean age 65.23 (SD=10.26) years; glycated hemoglobin levels, 6.9% (SD=0.9%); diabetes duration, 9.1 (SD=0.6) years; and body mass index, 30.8 (SD=0.5) kg/m(2). Mean FAM-III scores for the 3 scaleswere 41.7 (SD=1.0), 41.5 (SD=0.9) and 38.5 (SD=1.1), respectively. Correlation coefficients were -0.06 (p=0.37), -0.09 (p=0.18) and -0.12 (p=0.06), showing no significant correlation between scales and glycated hemoglobin levels levels in the 3 perspectives before and after adjustment for confounders. Family function correlated with burden of diabetes at 0.14 (p=0.02), 0.24 (p=0.0003) and 0.16 (p=0.01), respectively, and mental health at -0.21 (p=0.0007), -0.23 (p=0.0005) and -0.25 (p<0.0001), respectively. Conclusion: The results of our study suggest that in patients with type 2 diabetes, family function does not predict the level of glycemic control. However, we found an association among healthy family function, low burden of diabetes and strong mental health, issues that are important for the patients' quality of life, compliance with lifestyle factors and diabetes self-management. (C) 2018 Canadian Diabetes Association.

To evaluate whether management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care has noninferior HbA1c outcomes compared with mono‐sectorial management in a specialized outpatient clinic.

AIM:To describe the patient's experience of family function and its importance in diabetes-related self-management.BACKGROUND:Many patients fail to reach the targeted glycemic level due to low self-management adherence. Knowledge is needed regarding the impact of family function on diabetes self-management.DESIGN:A qualitative descriptive design.METHODS:A purposive sample of 20 patients with type 2 diabetes. Data were collected in March-June 2017 via audio-recorded semi-structured interviews, field notes and Eco-maps. Analysed using thematic framework matrix and thematic analysis.RESULTS:Four themes were identified: (1) Downplaying disease. The disease was trivialized creating a barrier to family involvement; (2) Second guessing. When diabetes was not discussed, patient and family made their own assumptions; (3) Going it alone. The participants preferred sole disease responsibility to maintain usual family life; (4) No regrets. The participants managed their disease with medications only to maintain family cohesion and 'the good life'.CONCLUSION:The participants in our study downplayed the consequences of type 2 diabetes and chose to control their disease medically rather than by lifestyle changes. They renounced family involvement to maintain their lifestyle and promote family cohesion.IMPACT:During clinical check-ups, patients should be encouraged to involve their family in lifestyle changes. Healthcare professionals need to recognize illness- and treatment beliefs and the impact of family function in disease management.

As many as 50% of patients with chronic diarrhea may suffer from bile acid malabsorption (BAM).1Wilcox C. et al.Aliment Pharmacol Ther. 2014; 39: 923-939Crossref PubMed Scopus (68) Google Scholar BAM is associated with spillover of bile acids from the small intestine to the colon, triggering osmotic-induced fluid secretion with subsequent watery diarrhea and high stool frequency alongside gastrointestinal symptoms, such as abdominal pain and bloating.1Wilcox C. et al.Aliment Pharmacol Ther. 2014; 39: 923-939Crossref PubMed Scopus (68) Google Scholar The gold standard for the diagnosis of BAM is the 75selenium-homotaurocholic acid test (SeHCAT), which evaluates the 7-day retention of orally administered 75selenium-labeled bile acids. Retention of ≥15% is consistent with normal bile acid reabsorption, 10% to 15% is considered mild BAM, 5% to 10% moderate, and <5% retention severe BAM.2Vijayvargiya P. et al.Clin Gastroenterol Hepatol. 2013; 11: 1232-1239Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar Bile acid sequestrants are the only approved pharmacological treatment for BAM. These drugs act through luminal binding of bile acids, which eliminates the osmotic effects of bile and thereby causes a reduction of colonic fluid secretion. However, many patients respond poorly to bile acid sequestrant treatment1Wilcox C. et al.Aliment Pharmacol Ther. 2014; 39: 923-939Crossref PubMed Scopus (68) Google Scholar and new treatment options for BAM are highly needed. Here we present 2 cases of BAM in which the glucagon-like peptide 1 (GLP-1) receptor agonist liraglutide (Victoza) was initiated as a treatment of overweight and type 2 diabetes, respectively, and caused complete remission of BAM symptoms. A 65-year-old woman experienced diarrhea with up to 7 watery stools per day, abdominal pain, and bloating following a cholecystectomy in 2011. The woman was diagnosed with severe BAM by SeHCAT (5% retention) in 2013. Treatment with the bile acid sequestrant cholestyramine was initiated with only modest effect and the woman continued to experience high stool frequency and reduced quality of life. In 2015, the woman initiated subcutaneous liraglutide treatment for her overweight (initiated at 0.6 mg once-daily and up-titrated to 1.2 mg once-daily). A few days after treatment initiation, the woman experienced total remission of BAM symptoms, including normalization of stool frequency and consistency. Relapses of BAM symptoms were reported on days when the liraglutide dose was missed and during an attempt to down-titrate liraglutide from 1.2 mg to 0.6 mg daily. SeHCAT performed following initiation of liraglutide treatment demonstrated a normal 75selenium-labeled bile acid retention above 20%. At control visits in 2016, 2017, and 2018, the woman reported no BAM-related symptoms, and at her last visit, she reported 1 daily bowel movement with normal consistency and a high quality of life on liraglutide treatment. A 49-year-old man experienced watery diarrhea with high stool frequency and was diagnosed with severe BAM by SeHCAT (5% retention) in 2013. Treatment with cholestyramine caused no relief of BAM symptoms. In September 2017, the man was diagnosed with type 2 diabetes and initiated liraglutide treatment, which resulted in an immediate and total remission of gastrointestinal symptoms. At a control visit in February 2018, the man reported 1 bowel movement per day with normal consistency. SeHCAT performed in June 2018 showed an unchanged 75selenium-labeled bile acid retention of 5%, but the man continued to be without BAM-related symptoms and experienced increased quality of life on liraglutide treatment. The incretin hormone GLP-1 is well known for its glucose-lowering and satiety-promoting actions. In addition, GLP-1 delays upper gastrointestinal motility, and treatment with the GLP-1 receptor agonist liraglutide increases small intestinal transit time.3Hellström P.M. et al.Neurogastroenterol Motil. 2008; 20: 649-659Crossref PubMed Scopus (87) Google Scholar, 4Nakatani Y. et al.Diabetes Metab. 2017; 43: 430-437Crossref PubMed Scopus (19) Google Scholar Likely, this enhances passive reabsorption of bile acids from the gut to the bloodstream with a subsequent reduction in spillover of bile acids to the colon (Figure 1). During the process of passive reabsorption, bile acids stimulate the nuclear farnesoid X receptor (FXR) in enterocytes.1Wilcox C. et al.Aliment Pharmacol Ther. 2014; 39: 923-939Crossref PubMed Scopus (68) Google Scholar The activation of FXR stimulates the synthesis and secretion of fibroblast growth factor 19 (FGF19), which in turn reduces the de novo synthesis of bile acids via suppression of CYP7a1 activity in the liver.5Holt J.A. et al.Genes Dev. 2003; 17: 1581-1591Crossref PubMed Scopus (500) Google Scholar, 6Inagaki T. et al.Cell Metab. 2005; 2: 217-225Abstract Full Text Full Text PDF PubMed Scopus (1161) Google Scholar Interestingly, individuals with BAM have reduced plasma concentrations of FGF19 compared with healthy subjects,7Walters J.R.F. et al.Clin Gastroenterol Hepatol. 2009; 7: 1189-1194Abstract Full Text Full Text PDF PubMed Scopus (215) Google Scholar which points to a compromised negative feedback on bile acid synthesis that could potentially add fuel to the fire by which BAM symptoms burn. Thus, liraglutide-induced deceleration of small intestinal transit time and ensuing greater passive reabsorption of bile acids in these patients may not only reduce spillover of bile acids to the colon, it may also increase FXR activation and restore FGF19-mediated negative feedback on bile acid synthesis (Figure 1), grabbing BAM pathophysiology by the root.

A large (apparently, infinite!) number of internal symmetries of the lattice ZN is identified.

Decreased quality of life is described more often in hypothyroid patients, who are treated with a synthetic form of thyroxine (L-T4), than in euthyroid controls. A combination of L-T4 and a synthetic form of triiodothyronine (L-T3) has been suggested; however, previous meta-analyses on unselected patients did not find any effect. Recent studies demonstrate, that the overall hypothalamic-pituitary-thyroid-tissue homeostasis could be more complex than previously suggested. Polymorphisms in deiodinase and thyroid hormone transporter genes could theoretically explain, why a minor subgroup of hypothyroid patients seem to have an effect of L-T4/L-T3 combination therapy.

Treatment of patients with type 2 diabetes is directed against treating symptoms of hyperglycemia, minimizing the risk of hypoglycemia, and the risk of microvascular and macrovascular complications. The majority of patients with type 2 diabetes die from cardiovascular or cerebrovascular disease. Future therapies should therefore focus on reducing cardiovascular morbidity in this high-risk population. Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose co-transporter 2 inhibitors (SGLT2-i) are two drug classes with proven antihyperglycemic effect in type 2 diabetes. However, these drugs seem to have other effects such as weight reduction, low risk of hypoglycemia, and blood pressure reduction. Emerging evidence suggests pleiotropic effects, which potentially could be important in reducing cardiovascular risk. Prompted by regulatory authorities demanding cardiovascular outcome trials (CVOTs) assessing the cardiovascular safety of new antihyperglycemic drug candidates, many CVOTs are ongoing and a few of these are finalized. Somewhat surprising recent CVOTs in both drug classes have shown promising data on cardiovascular morbidity and mortality in patients with a very high risk of cardiovascular events. It is uncertain whether this is a class effect of the two drug classes, and it is yet unproven whether long-term cardiovascular benefits of these drugs can be extrapolated to populations at lower risk of cardiovascular disease. The aim of the present review is to give an overview of our current knowledge of the GLP-1RA and SGLT2-i classes, with specific focus on mechanisms of action, effects on cardiovascular risk factors and cardiovascular morbidity and mortality from the CVOTs presently available. The clinical potential of these data is discussed.