Factors affecting continuous participation in follow-up evaluations during a lifestyle intervention programme for type 2 diabetes prevention: The Feel4Diabetes-study.

AIMS: Community- and school-based lifestyle interventions are an efficient method of preventing type 2 diabetes in vulnerable populations. Many participants, however, fail to complete the necessary follow-ups. We investigated factors affecting the continuous participation in follow-up evaluations during the Feel4Diabetes-study, a multilevel intervention programme implemented across Europe. METHODS: Socioeconomic, sociodemographic and clinical factors were assessed for 2702 participants within six participating countries: Bulgaria and Hungary (low-to-middle-income countries, LMIC), Belgium and Finland (high-income countries, HIC) and Greece and Spain (high-income countries under austerity measures, HICAM). RESULTS: Statistically significant differences were detected with respect to sex, control group, education level, employment status, BMI and blood pressure measurements (systolic and diastolic blood pressure). Post hoc analysis revealed significant differences within socioeconomic regions. Higher levels of education were associated with significantly lower attrition in HIC (p < 0.05) and HICAM (p < 0.001), higher employment status was associated with lower attrition in HICAM (p < 0.001) and being female was associated with lower attrition in LMIC (p < 0.001). Surprisingly, the intervention group exhibited higher-than-expected attrition in HIC (p < 0.001) and HICAM (p = 0.003), and lower attrition in LMIC (p = 0.007). When tested together in the same multivariable predictive model, all sociodemographic and socioeconomic variables along with higher BMI retained their statistical significance, while systolic and diastolic blood pressure failed to remain significant. CONCLUSIONS: Key socioeconomic and sociodemographic factors along with BMI play a significant role in determining continuous participation in follow-up evaluations during school- and community-based intervention programmes.

[The effectiveness of digital care applications in people with need of home care: A systematic review]. / Effektivität digitaler Pflegeanwendungen bei Pflegebedürftigen im häuslichen Umfeld.

The effectiveness of digital care applications in people with need of home care: A systematic review Abstract: Background: The growing need for long-term care poses challenges for healthcare systems. In June 2021, digital care applications (DiPA) were introduced as a new service in the statutory long-term care insurance in Germany. Their aim is to counteract the increased care need and/or support independence in the home. Aim: This project systematically identified and reported on national and international evidence on DiPA effectiveness, as described by the Federal Institute for Drugs and Medical Devices (BfArM). Methods: The systematic review was conducted in accordance with the PRISMA statement by means of systematic searches in the databases Medline and Cinahl, and supplemented by an extensive manual search (08/2022). Study quality was assessed using the Risk of Bias Tool (RoB2). The results were synthesized narratively. Results: Eight randomized controlled studies were included; improvements in cognition, activities of daily living, and mobility in home care patients, were reported. Study quality was low to moderate, due to mostly unblinded study designs and low case numbers. Conclusions: The currently available evidence fails to provide a reliable basis for assessing the benefits of DiPA, to neither DiPA manufacturers, nor to responsible parties in the healthcare system. Further research on DiPA effectiveness, particularly with high-quality studies, are necessary to assess its potential in the German care sector.

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis.

BACKGROUND: With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. OBJECTIVE: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. METHODS: A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. RESULTS: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. DISCUSSION: It is striking that- although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes - all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. CONCLUSION: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.

[Development, Evaluation and Implementation of Digital Health Interventions (Part 1) - Discussion Paper of the Digital Health Working Group of the German Network for Health Services Research (DNVF)]. / Digitale Gesundheitsinterventionen entwickeln, evaluieren und implementieren (Teil I) ­ Diskussionspapier der Arbeitsgruppe Digital Health des Deutschen Netzwerk Versorgungsforschung (DNVF).

The development and application of digital interventions in health-related topics are gaining momentum in health service research. Digital interventions are often complex and need to be evaluated and implemented in complex settings. Due to their characteristics, this poses methodological challenges for health services research that have to be identified and addressed. Hence, the Working Group on Digital Health of the German Network for Health Services Research (DNVF) has prepared a discussion paper. This paper discusses methodological, practical and theoretical challenges associated with the development and evaluation of digital interventions from the perspective of health services research. Possible solutions are suggested and future research needs to address these methodological challenges are identified.

[Developing, Evaluating and Implementing Digital Health Interventions Part II - Discussion Paper of the Digital Health Working Group of the German Network for Health Services Research (DNVF)]. / Digitale Gesundheitsinterventionen entwickeln, evaluieren und implementieren Teil II ­ Diskussionspapier der Arbeitsgruppe Digital Health des Deutschen Netzwerk Versorgungsforschung (DNVF).

The methodological challenges of evaluating digital interventions (DI) for health services research are omnipresent. The Digital Health Working Group of the German Network for Health Services Research (DNVF) presented and discussed these challenges in a two-part discussion paper. The first part addressed challenges in definition, development and evaluation of DI. In this paper, which represents the second part, the definition of outcomes, reporting of results, synthesis of evidence, and implementation are addressed as methodological challenges of DI. Potential solutions are presented and the need to address these challenges in future research are discussed.

Parental insulin resistance is associated with unhealthy lifestyle behaviours independently of body mass index in children: The Feel4Diabetes study.

Parental health is associated with children's health and lifestyles. Thus, the aim of the present study was to assess lifestyle behaviours of children of parents with insulin resistance (IR) and at risk of type 2 diabetes. 2117 European families from the Feel4Diabetes-study were identified as being at risk for diabetes with the FINDRISC questionnaire and included in the present study. One parent and one child per family were included. Parental IR was considered when homeostasis model assessment (HOMA) was equal or higher than 2.5. Children's screen-time, physical activity and diet were assessed and clustered by K-means. Weight and height were measured and children's body mass index (BMI) was calculated. For children, a Healthy Diet Score (HDS) was calculated. Linear regression and multilevel logistic regression analyses were performed to assess the associations between parental IR and children's lifestyle behaviours in 2021. Children of parents with IR had higher BMI (p < 0.001) and spent more screen time (p = 0.014) than those of non-IR parents. Children of parents with IR had a lower value in the breakfast and vegetable components of the HDS (p = 0.008 and p = 0.05). Four lifestyle clusters were found. Children of IR parents had higher odds of being in a non-healthy cluster (OR: 1.19; 95%CI: 1.001-1.437). CONCLUSION: Having an IR parent was associated with a high screen time and an increased probability of having an unhealthy lifestyle pattern in children. These data point out that children's lifestyles should be assessed in families with IR parents to provide tailored interventions. WHAT IS KNOWN: • Children with diabetic or insulin-resistant parents could also develop this condition. • Unhealthy lifestyles are directly related with insulin resistance even in children. WHAT IS NEW: • Children from parents with insulin resistance have higher chances of unhealthy lifestyles. • A higher BMI was found for those children with an insulin-resistant parent.

[Treatment practice of patients with Parkinson's disease in Saxony : A secondary data-based analysis of utilization in the observation period 2011-2019]. / Versorgungssituation von Parkinson-Patienten in Sachsen : Eine sekundärdatenbasierte Analyse der Inanspruchnahme im Beobachtungszeitraum 2011 bis 2019.

BACKGROUND: The consequences of demographic change are already noticeable in Saxony, the federal state with the highest average age in Germany and predominantly rural areas. In order to improve medical care for patients with Parkinson's disease (PwP), a status quo analysis of current care practice is required. OBJECTIVE: To what extent does the utilization of medical services by PwP differ a) between urban and rural areas in Saxony and b) between PwP with and without neurologist contact in the observation period from 2011 to 2019? MATERIAL AND METHODS: The cohort study was based on extensive routine data for Saxony from the health insurance company AOK PLUS from 2010 to 2019. A cohort of 15,744 PwP (n = 67,448 patient-years) was compared to a matched cohort (n = 674,480 patient-years; criteria: year of birth, gender, year of insurance, place of residence: urban/rural) without an ICD-10 coding of a movement disorder. RESULTS: Overall, there was a steady increase in the number of PwP in the dynamic cohort from 2011 (n = 6829) to 2019 (n = 8254). Urban-rural differences included a smaller proportion of patients being seen by a neurologist in rural areas. The PwP had a 3.5 to 4­fold higher risk of dying compared to those in the comparison cohort. Changes in drug therapy for Parkinson's disease (i.e., increases in COMT and MAO inhibitors) and in remedy delivery (i.e., increases in occupational therapy and speech therapy) over the observation period were primarily seen in PwP who were seen by a neurologist. DISCUSSION: The study identified increased morbidity and mortality in PwP who are suitable targets for innovative care concepts. The increasing number of patients and the described differences document the need for this. At the same time, changes in prescription practice show that innovative forms of treatment are being used by neurologists in outpatient care.

Cost-effectiveness analysis of a school- and community-based intervention to promote a healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: the Feel4Diabetes-study.

The Feel4Diabetes-study implemented a school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes mellitus (T2DM) in six European countries. The intervention included a special focus on families at increased T2DM risk. The current study evaluates the intervention's cost-effectiveness. A Markov-type health economic model was developed to predict the incidence of T2DM and its complications. Incremental cost-effectiveness ratios (lifetime horizon, societal perspective) were calculated based on the overall intervention effect on health behaviour, and stratified for low- and high-risk families. Sensitivity analyses captured input parameters uncertainty. A budget impact analysis was performed. The increase in children's water consumption and physical activity led to a modest gain in quality adjusted life years (QALYs) at a low intervention cost and budget impact. Medical cost savings due to avoided illness could only be achieved on the very long-term (>30 years). The intervention in its entirety was cost-effective (more QALYs at a reasonable investment) in Belgium, Finland, Bulgaria, and Hungary, while being dominant (net savings and more QALYs) in Greece and Spain. Results were cost-effective for the low-risk families, who only received the school- and community-based intervention component. Results for the high-risk families were only cost-effective (with considerable uncertainty) in Greece and Spain, but not when the intervention would need to be repeated. The Feel4Diabetes-intervention is potentially cost-effective, especially in countries with a high overweight and obesity prevalence, at a limited budget impact. The incremental financial investments to reach and support high-risk families did not result in the hoped-for health benefits.

European Childhood Obesity Risk Evaluation (CORE) index based on perinatal factors and maternal sociodemographic characteristics: the Feel4Diabetes-study.

The aim of this study was to develop and examine the predictive accuracy of an index that estimates obesity risk in childhood based on perinatal factors and maternal sociodemographic characteristics. Analysis was conducted by using cross-sectional and retrospective data collected from a European cohort of 2775 schoolchildren and their families participating in the Feel4Diabetes-study. The cohort was randomly divided by using two-thirds of the sample for the development of the index and the remaining one third for assessing its predictive accuracy. Logistic regression analyses determined a prediction model for childhood obesity. The area under the receiver operating characteristic curve (AUC-ROC), sensitivity, specificity, and positive and negative predictive values (PPV, NPV) were calculated. Cut-off analysis was applied to identify the optimal value of the index score that predicts obesity with the highest possible sensitivity and specificity. Eight factors were found to be significantly associated with obesity and were included as components in the European "Childhood Obesity Risk Evaluation" (CORE) index: region of residence, maternal education, maternal pre-pregnancy weight status, gestational weight gain, maternal smoking during pregnancy, birth weight for gestational age, infant growth velocity, and exclusive breastfeeding during the first 6 months. Risk score ranged from 0 to 22 corresponding to a risk from 0.9 to 54.6%. The AUC-ROC was 0.725 with optimal cut-off ≥9 (sensitivity = 74.1%, specificity = 61.0%, PPV = 11.3%, NPV = 97.2%).Conclusion: The European CORE index can be used as a screening tool for the identification of infants at high-risk for becoming obese at 6-9 years. This tool could assist healthcare professionals in initiating preventive measures from the early life.Trial registration: The Feel4Diabetes-intervention is registered at https://clinicaltrials.gov/ ; number, CT02393872; date, March 20, 2015. What is Known: • As prevention of obesity should start early in life, there is a compelling rationale for the early identification of high-risk children to facilitate targeted intervention. What is New: • This study developed and assessed the predictive accuracy of an index for the Childhood Obesity Risk Evaluation (CORE), combining certain perinatal factors and maternal sociodemographic characteristics in a large European cohort. • The European CORE index can be used as a screening tool for identifying infants at high-risk for becoming obese at 6-9 years and assist health professionals in initiating early prevention strategies.

Sociodemographic and lifestyle-related risk factors for identifying vulnerable groups for type 2 diabetes: a narrative review with emphasis on data from Europe.

BACKGROUND: Type 2 diabetes mellitus (T2DM) comprises the vast majority of all diabetes cases in adults, with alarmingly increasing prevalence over the past few decades worldwide. A particularly heavy healthcare burden of diabetes is noted in Europe, where 8.8% of the population aged 20-79 years is estimated to have diabetes according to the International Diabetes Federation. Multiple risk factors are implicated in the pathogenesis of T2DM with complex underlying interplay and intricate gene-environment interactions. Thus, intense research has been focused on studying the role of T2DM risk factors and on identifying vulnerable groups for T2DM in the general population which can then be targeted for prevention interventions. METHODS: For this narrative review, we conducted a comprehensive search of the existing literature on T2DM risk factors, focusing on studies in adult cohorts from European countries which were published in English after January 2000. RESULTS: Multiple lifestyle-related and sociodemographic factors were identified as related to high T2DM risk, including age, ethnicity, family history, low socioeconomic status, obesity, metabolic syndrome and each of its components, as well as certain unhealthy lifestyle behaviors. As Europe has an increasingly aging population, multiple migrant and ethnic minority groups and significant socioeconomic diversity both within and across different countries, this review focuses not only on modifiable T2DM risk factors, but also on the impact of pertinent demographic and socioeconomic factors. CONCLUSION: In addition to other T2DM risk factors, low socioeconomic status can significantly increase the risk for prediabetes and T2DM, but is often overlooked. In multinational and multicultural regions such as Europe, a holistic approach, which will take into account both traditional and socioeconomic/socioecological factors, is becoming increasingly crucial in order to implement multidimensional public health programs and integrated community-based interventions for effective T2DM prevention.

Methodology of the health economic evaluation of the Feel4Diabetes-study.

BACKGROUND: The clinical and economic burden of type 2 diabetes mellitus on society is rising. Effective and efficient preventive measures may stop the increasing prevalence, given that type 2 diabetes mellitus is mainly a lifestyle-driven disease. The Feel4Diabetes-study aimed to tackle unhealthy lifestyle (unhealthy diet, lack of physical activity, sedentary behaviour, and excess weight) of families with a child in the first grades of elementary school. These schools were located in regions with a relatively low socio-economic status in Belgium, Bulgaria, Finland, Greece, Hungary and Spain. Special attention was paid to families with a high risk of developing type 2 diabetes mellitus. METHODS: The aim of this paper is to describe the detailed methodology of the intervention's cost-effectiveness analysis. Based on the health economic evaluation of the Toybox-study, both a decision analytic part and a Markov model have been designed to assess the long-term (time horizon of 70 year with one-year cycles) intervention's value for money. Data sources used for the calculation of health state incidences, transition probabilities between health states, health state costs, and health state utilities are listed. Intervention-related costs were collected by questionnaires and diaries, and attributed to either all families or high risk families only. CONCLUSIONS: The optimal use of limited resources is pivotal. The future results of the health economic evaluation of the Feel4Diabetes-study will contribute to the efficient use of those resources.

Mapping the Evidence on the Effectiveness of Telemedicine Interventions in Diabetes, Dyslipidemia, and Hypertension: An Umbrella Review of Systematic Reviews and Meta-Analyses.

BACKGROUND: Telemedicine is defined by three characteristics: (1) using information and communication technologies, (2) covering a geographical distance, and (3) involving professionals who deliver care directly to a patient or a group of patients. It is said to improve chronic care management and self-management in patients with chronic diseases. However, currently available guidelines for the care of patients with diabetes, hypertension, or dyslipidemia do not include evidence-based guidance on which components of telemedicine are most effective for which patient populations. OBJECTIVE: The primary aim of this study was to identify, synthesize, and critically appraise evidence on the effectiveness of telemedicine solutions and their components on clinical outcomes in patients with diabetes, hypertension, or dyslipidemia. METHODS: We conducted an umbrella review of high-level evidence, including systematic reviews and meta-analyses of randomized controlled trials. On the basis of predefined eligibility criteria, extensive automated and manual searches of the databases PubMed, EMBASE, and Cochrane Library were conducted. Two authors independently screened the studies, extracted data, and carried out the quality assessments. Extracted data were presented according to intervention components and patient characteristics using defined thresholds of clinical relevance. Overall certainty of outcomes was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. RESULTS: Overall, 3564 references were identified, of which 46 records were included after applying eligibility criteria. The majority of included studies were published after 2015. Significant and clinically relevant reduction rates for glycated hemoglobin (HbA1c; ≤-0.5%) were found in patients with diabetes. Higher reduction rates were found for recently diagnosed patients and those with higher baseline HbA1c (>8%). Telemedicine was not found to have a significant and clinically meaningful impact on blood pressure. Only reviews or meta-analyses reporting lipid outcomes in patients with diabetes were found. GRADE assessment revealed that the overall quality of the evidence was low to very low. CONCLUSIONS: The results of this umbrella review indicate that telemedicine has the potential to improve clinical outcomes in patients with diabetes. Although subgroup-specific effectiveness rates favoring certain intervention and population characteristics were found, the low GRADE ratings indicate that evidence can be considered as limited. Future updates of clinical care and practice guidelines should carefully assess the methodological quality of studies and the overall certainty of subgroup-specific outcomes before recommending telemedicine interventions for certain patient populations.

What should governments be doing to prevent diabetes throughout the life course?

Health systems and governments are increasingly required to implement measures that target at-risk populations to prevent noncommunicable diseases. In this review we lay out what governments should be doing to prevent diabetes throughout the life course. The following four target groups were used to structure the specific recommendations: (1) pregnant women and young families, (2) children and adolescents, (3) working age population, and (4) the elderly. The evidence to date supports the effectiveness of some known government policy measures, such as sugar taxes and regulatory measures in the (pre-)school setting for children and adolescents. Many of these appear to be more effective if they are part of a bundle of strategies and if they are supplemented by communication strategies. Although there is a current focus on strategies that target the individual, governments can make use of evidence-based population-level prevention strategies. More research and continuous evaluation of the overall and subgroup-specific effectiveness of policy strategies using high-quality longitudinal studies are needed.

[Release of antibiotics into urban wastewater: A secondary-data based analysis for the input assessment using the city of Dresden as an example]. / Antibiotikaeintrag in das urbane Abwasser : Eine sekundärdatenbasierte Analyse zur Eintragsabschätzung am Beispiel der Stadt Dresden.

Antibiotics are essential for the successful treatment of bacterial infections. Recently, the increasing number of resistant bacteria and the occurrence of residues of antibiotics in the environment has become the focus of scientific interest. The aim of the cooperative project ANTI-Resist was to investigate the release of antibiotics and the occurrence and distribution of antibiotic resistance in the urban waste water system of the city of Dresden.This article presents the main results of the secondary data analysis for the determination of outpatient and inpatient antibiotic consumption and provides an insight into the complexity of the topic antibiotics in waste water.Based on the data of outpatient prescriptions provided by the AOK PLUS for the period 2005 to 2013, thirteen focus substances were identified to estimate antibiotic consumption. Furthermore, delivery data from the pharmacies of three hospitals in Dresden were available.Depending on the substances investigated, seasonality and age dependency were determined. The results at a regional level were mostly in good accordance with general trends throughout Germany. It should be noted that the total amount of antibiotics used remained nearly constant over the whole period investigated, but the prescription of fluoroquinolones increased. This must be questioned when taking into account the increasingly critical situation in the treatment of Gram-negative bacteria in particular. Examinations of waste water conducted indicated that sewage treatment plants are not able to remove antibiotics or their metabolites completely from waste water. The residues are released into surface waters via the treatment plants. The impact cannot be assessed at the moment and further investigations are necessary.

Impact of COPD on mortality: An 8-year observational retrospective healthcare claims database cohort study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality. Here we present a large observational study on the association of COPD and exacerbations with mortality (AvoidEx Mortality). METHODS: A real-world, observational cohort study with longitudinal analyses of German healthcare claims data in patients ≥40 years of age with a COPD diagnosis from 2011 to 2018 (n = 250,723) was conducted. Patients entered the cohort (index date) upon the first COPD diagnosis. To assess the impact of COPD on all-cause death, a propensity score-matched control group of non-COPD patients was constructed. The number and severity of exacerbations during a 12-month pre-index period were used to form subgroups. For each exacerbation subgroup the exacerbations during 12 months prior to death were analysed. RESULTS: COPD increases the all-cause mortality risk by almost 60% (HR 1.57 (95% CI 1.55-1.59)) in comparison to matched non-COPD controls, when controlling for other baseline covariates. The cumulative risk of death after 8 years was highest in patients with a history of more than one moderate or severe exacerbation. Among all deceased COPD patients, 17.2% had experienced a severe, and 34.8% a moderate exacerbation, within 3 months preceding death. Despite increasing exacerbation rates towards death, more than the half of patients were not receiving any recommended pharmacological COPD therapy in the year before death. CONCLUSION: Our study illustrates the impact of COPD on mortality risk and highlights the need for consequent COPD management comprising exacerbation assessment and treatment.

Elucidating the risk of cardiopulmonary consequences of an exacerbation of COPD: results of the EXACOS-CV study in Germany.

BACKGROUND: Exacerbations of chronic obstructive pulmonary disease (COPD) represent a period of vulnerability. This study explored the association between time periods following an exacerbation and the risk of severe cardiovascular (CV) events or death in Germany. METHODS: A longitudinal cohort study was conducted using routinely collected healthcare data. Individuals with COPD were identified between 2014 and 2018. Exposure was moderate or severe exacerbation of COPD. Periods at risk were the 1-7, 8-14, 15-30, 31-180 and 181-365 days following each exacerbation onset occurring after cohort entry. The main outcome of interest was the first hospitalisation for a CV event or all-cause death. Time-dependent Cox proportional hazards models estimated the HR for the association between subperiods versus periods outside exacerbations, and the risk of outcome. RESULTS: Among 126 795 patients, 58 720 (46.3%) exacerbated at least once and 48 982 (38.6%) experienced at least one CV event or died during a median follow-up of 36 months. The rate of outcome was increased during 1-7 days following a severe exacerbation onset (HR 15.84, 95% CI 15.26 to 16.45), and remained elevated for up to a year (181-365 days HR 1.17, 95% CI 1.11 to 1.23). In the 1-7 days following a moderate exacerbation onset, the increased rate was HR 1.17, 95% CI 1.05 to 1.31). CONCLUSION: The risk of a CV event or death increased in time periods following both moderate and severe exacerbations of COPD, emphasising the need to promptly manage the risk of CV events following the onset of an exacerbation, to prevent exacerbations of any severity, and more generally, to address the cardiopulmonary risk in patients with COPD.

Design of the DAVOS Study: Diabetes Smartphone App, a Fully Automatic Transmission of Data From the Blood Glucose Meter and Insulin Pens Using Wireless Technology to Enhance Diabetes Self-Management-A Study Protocol for a Randomized Controlled Trial.

BACKGROUND: In the treatment of diabetes mellitus, the challenge is to integrate adequate self-management into clinical care. Customization including goal setting, monitoring, and feedback could be achieved through digitization. Digital linking between different devices could simplify and promote self-management. The aim of this study is to evaluate the outcome of diabetes treatment assisted by a digital health application compared with standard diabetes therapy. METHODS: The DAVOS study is a 6-month-period prospective, multicentric, randomized controlled trial. In total, 154 diabetes patients (age ≥18; treated with insulin) will be recruited and randomized into control group or intervention group. Both groups will receive standard diabetes care. The intervention group will additionally use a diabetes app. HbA1c value will be monitored on three separate defined visits. Primary endpoint is the overall reduction of HbA1c value. Secondary endpoints (eg, usability of the app) will be determined through patient-reported outcome questionnaires. DISCUSSION: Through enhanced interaction of health care professionals, providers of the app, and patients, the study aims to demonstrate improvement in the self-management of diabetes. As part of the closure management, all patients will be invited to use the examined application after completion of the study. The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization-Good Clinical Practice (ICH-GCP) Guidelines. Special attention will be paid to European, national, and regional requirements for the approval, provision, and use of medical devices. The study was registered in the German Register of Clinical Trials (DRKS) with number DRKS00025996.

Effectiveness of Digital Health Interventions Containing Game Components for the Self-management of Type 2 Diabetes: Systematic Review.

BACKGROUND: Games and game components have become a major trend in the realm of digital health research and practice as they are assumed to foster behavior change and thereby improve patient-reported and clinical outcomes for patients with type 2 diabetes. OBJECTIVE: The aim of this systematic review was to summarize and evaluate the current evidence on the effectiveness of digital health interventions containing game components on behavioral, patient-reported, and clinical outcomes for patients with type 2 diabetes. METHODS: An electronic search was conducted in MEDLINE and PsycINFO in April 2020; updated in April 2022; and supplemented by additional searches via Google Scholar, Web of Science (which was used for forward citation tracking), and within the references of the included records. Articles were identified using predefined inclusion and exclusion criteria. In total, 2 reviewers independently conducted title, abstract, and full-text screening and then individually performed a critical appraisal of all the included studies using the Cochrane risk-of-bias tool version 2. A consensus was reached through discussion. RESULTS: Of 2325 potentially relevant titles (duplicates excluded), 10 (0.43%) randomized controlled trials were included in this review. Quality assessment revealed a high risk of bias for all randomized controlled trials except for 10% (1/10), with performance bias due to the lack of blinding being the major source of bias. There is evidence suggesting that digital health interventions containing game components can substantially improve motivation for physical activity (1/1, 100% of the studies dealing with PA motivation), exercise intensity (3/5, 60%), dietary behavior (4/4, 100%), health literacy (1/3, 33%), mental quality of life (2/2, 100%), glycated hemoglobin level (2/6, 33%), BMI (1/3, 33%), fasting plasma glucose level (1/2, 50%), waist circumference (1/1, 100%), and aerobic capacity (1/1, 100%). CONCLUSIONS: Published studies indicated that digital health interventions containing game components might improve health behavior patterns, quality of life, and clinical outcomes in patients with type 2 diabetes. However, the intervention types and outcomes studied were heterogeneous, and study quality was mostly low, which translates to ambiguous results. Future research should focus on sound methodology and reporting as well as on identifying game components that contribute to significant positive effects. TRIAL REGISTRATION: PROSPERO CRD42020209706; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=209706.