Systematische Übersicht und Bewertung digitaler Interventionen zur Diabetesprävention und –versorgung

Background: The prevalence of type 2 diabetes mellitus (T2D) and the number of patients with comorbidities like hypertension, dyslipidemia and cardiovascular diseases are increasing worldwide. Evidence-based medicine uses the best available evidence from systematic research to make decisions about the care of individual patients. The systematisation and appraisal of evidence are done in care guidelines, which in turn aim to guide the application of effective diabetes prevention and care interventions in different age groups and settings. Patients with T2D need continuous and individualised care. They are therefore seen as the ideal target group for the use of digital health interventions like telemedicine. However, heterogeneous patient populations, telemedicine phenotypes and settings hamper the evaluation of digital health interventions. Comparing study results to provide evidence-based recommendations is further complicated by the diversity of applied study designs. Therefore, there is a need for a systematic review of the current state of research while considering the described variability. In line with this aim five research studies were conducted. Objective: The overall objective of this thesis was, to identify current needs of patients with diabetes (publication 1), to systematically analyse the effectiveness of different diabetes prevention and care interventions (publications 2+3) and to evaluate digital diabetes prevention and care interventions (publications 4+5). Material und Method: To analyse current needs of patients with diabetes, three substudies were conducted in the beginning (publication 1). They consisted of a standardised survey of experts to analyse existing chronic care programs, an expert workshop to identify patients’ needs and an online survey to prioritise the categorised needs dimensions seen from the perspective of patients and health care providers. Two literature overviews were performed to analyse the best available evidence in diabetes prevention and care. An umbrella review analysed the available evidence to identify effective interventions of blood sugar regulation on cardiovascular risk (publication 2). Study quality was assessed using OQAQ (Overview Quality Assessment Questionnaire). Afterwards, a literature overview aimed to identify effective measures of population-based prevention and communication strategies to provide recommendations for policy makers on how to prevent diabetes in different age groups and settings (publication 3). In a next step, digital diabetes prevention and care interventions were summarised. To evaluate digital health interventions with more than one active function, a study protocol was developed. It describes the evaluation of a hypothetical gamification-based smartphone application for weight loss in overweight and obese adolescents (publication 4). As a last step, an umbrella review (publication 5) systematically analysed the effectiveness of telemedicine interventions in diabetes, dyslipidaemia and hypertension. Potentially relevant records had to analyse the effectiveness of telemedicine on clinical outcomes under real-life conditions in patients with one of the defined target diseases using either a systematic review or meta-analysis based on RCTs. Results of meta-analyses and their subgroup analyses were used to identify effective components or other characteristics (e.g. intensity or frequency of feedback). Overall certainty of outcomes was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tool. Results and Implications: The standardised survey on current care models indicated that a lack of national guidelines, cost-ineffective and non-individualised health care as well as long waiting periods were criticised. Education of patients, communication within the team and with the patient, prevention and health promotion as well as the accessibility of services were significantly more important to patients when compared to health care providers. The identified differences in priorities support the early assessment of these preferences. The umbrella review on the potential of blood sugar regulation for the reduction of cardiovascular risk identified 44 records which were of good quality (OQAQ-median = 17). The results suggest that pharmacological and non-pharmacological interventions have the potential to improve cardiovascular outcomes. When deciding for a certain intervention as well as its intensity, baseline blood pressure and cardiovascular risks of the patient should be considered. Guidelines on cardiovascular prevention should take into account pathophysiological mechanisms as well as individual lifestyle interventions. While effective measures for individual level prevention including physical activity and diet programs were found, available evidence for population-based intervention was scarce and insufficient. The literature overview conducted afterwards identified evidence-based interventions for population-based prevention, including taxation of unhealthy products and specific prevention strategies in certain settings (e.g. kindergartens, schools). These strategies may contribute to the development of policies and governmental regulations for the prevention of diabetes in different age groups and settings. To evaluate a digital mobile health intervention consisting of more than one component, a study protocol for a single-centre, two-arm, triple-blinded, randomised controlled trial following the CONSORT recommendations was developed. The intervention consists of a smartphone application that provides both tracking and gamification elements for lifestyle change. The control group uses an identically designed application, which solely features the tracking of health information. It appears favourable to use RCTs for proof of concept assessments, to evaluate the effectiveness of an app or specific components in controlled settings. The fifth publication of this thesis shows that telemedicine may lead to significant and clinically relevant reductions of HbA1c (≤ -0,5 %) in patients with T2D. The identified reduction rates are comparable to those of non-pharmacological and even some pharmacological interventions. Extracted subgroup analyses showed that certain population and intervention characteristics seem to be associated with improved clinical benefits. This applies to interventions with a rather short duration ( 8,0 %) were identified as population characteristics favourable for clinically relevant improvements of HbA1c. In addition to the characteristics, future updates of guidelines should carefully consider the low levels of certainty as indicated by the low GRADE results. The present thesis provides a systematic overview of effective measures in diabetes prevention and care. Overall, there is a potential for the early and structured assessment of patients’ preferences. The systematisation and appraisal of the best available evidence on the effectiveness of telemedicine in patients with diabetes and associated comorbidities revealed areas for the update of present guidelines. There is a need for methodologically robust studies on the effectiveness of telemedicine in specific populations and in consideration of combined digital health components. The results and identified research needs have the potential to motivate future studies.:Inhaltsverzeichnis I Abkürzungsverzeichnis III Abbildungsverzeichnis VI Tabellenverzeichnis VII Liste der entstandenen Publikationen VIII 1 Einführung in die Thematik 1 1.1 Diabetes 1 1.1.1 Epidemiologie 1 1.1.2 Krankheitstypen, Krankheitsstadien und Begleiterkrankungen 2 1.1.3 Diabetesprävention 5 1.1.4 Diabetesversorgung 6 1.2 Evidenzbasierte Medizin 9 1.3 Digitalisierung 14 1.4 Stand der Forschung 15 1.4.1 Unterstützungs- und Versorgungsprobleme 15 1.4.2 Individuelle und populationsbasierte Maßnahmen zur Diabetesprävention 16 1.4.3 Herausforderungen digitaler Diabetesprävention und -versorgung 22 1.5 Zieldefinition und Fragestellung 25 2 Thematischer Zusammenhang und Methodenüberblick 26 3 Individualising Chronic Care Management by Analysing Patients’ Needs – A Mixed Method Approach 28 4 Blood Sugar Regulation for Cardiovascular Health Promotion and Disease Prevention 31 5 What should governments be doing to prevent diabetes throughout the life course? 34 6 Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial 36 7 Mapping the Evidence on the Effectiveness of Telemedicine Interventions in Diabetes, Dyslipidemia, and Hypertension: An Umbrella Review of Systematic Reviews and Meta-Analyses 38 8 Diskussion und Ausblick 41 8.1 Einordnung der Ergebnisse 41 8.2 Limitationen und Methodenkritik 49 8.3 Wissenschaftliche Kontribution und Ausblick 50 9 Schlussfolgerung 51 10 Zusammenfassung 53 11 Summary 57 12 Literaturverzeichnis 60 13 Anhang 110 13.1 Wissenschaftliche Kontribution der Publikationen 110 13.2 Details zu Publikationen als Erstautor 112 13.3 Volltexte der entstandenen Veröffentlichungen 117 13.4 Curriculum Vitae 198 13.5 Danksagung 199 Anlage 1 200 Anlage 2 202Hintergrund: Die Häufigkeit des Typ-2-Diabetes mellitus (T2D) sowie die Zahl von Patienten mit Begleiterkrankungen wie Hypertonie, Lipidstoffwechselstörungen und kardiovaskulären Erkrankungen sind weltweit ansteigend. Die evidenzbasierte Medizin nutzt die beste verfügbare Evidenz aus systematischer Forschung um Entscheidungen für die individuelle Patientenversorgung zu treffen. Die Aufarbeitung und Bewertung der Evidenz erfolgt in Versorgungsleitlinien, welche wiederum zur Verwendung wirksamer Maßnahmen der Diabetesprävention und -versorgung in verschiedenen Altersgruppen und Settings anleiten können. Patienten mit T2D bedürfen der kontinuierlichen und individualisierten Versorgung. Sie gelten daher als ideale Patientengruppe, um digitale Versorgungsformen wie Telemedizin zu nutzen. Heterogene Patientenpopulationen, Telemedizinanwendungen und Settings erschweren jedoch die Evaluation digitaler Gesundheitsanwendungen. Zusätzlich wird durch die Diversität der angewandten Studiendesigns ein Vergleich der Studienergebnisse, mit dem Ziel evidenzbasierte Empfehlungen zu formulieren, verkompliziert. Es fehlt daher an einer systematischen Aufarbeitung des Forschungsstands unter Berücksichtigung der geschilderten Variabilität. Mit diesem Ziel wurden fünf Forschungsarbeiten angefertigt. Fragestellung: Übergeordnetes Ziel der vorliegenden Arbeit war es, bestehende Unterstützungs- und Versorgungsprobleme von Patienten mit Diabetes zu identifizieren (Publikation 1), die Wirksamkeit verschiedener Maßnahmen der Prävention und Versorgung des Diabetes systematisch aufzubereiten (Publikationen 2+3) und digitale Diabetespräventions- und –versorgungsstrategien zu bewerten (Publikationen 4+5). Material und Methode: Mit dem Ziel, bestehende Unterstützungs- und Versorgungsprobleme von Patienten mit Diabetes zu analysieren, wurden zu Beginn drei Teilstudien durchgeführt (Publikation 1). Diese beinhalteten eine standardisierte Expertenbefragung zu bestehenden Versorgungsmodellen, einen Workshop zur Identifikation von Versorgungs- und Unterstützungsproblemen und die Durchführung einer mehrsprachigen Online-Befragung zur Priorisierung der kategorisierten Problembereiche aus Sicht der Patienten und Leistungserbringer. Zur Analyse der besten verfügbaren Evidenz zur Diabetesprävention und –versorgung wurden zwei Übersichtsarbeiten durchgeführt. Ein Umbrella Review untersuchte die verfügbare Evidenz effektiver Maßnahmen der Blutzuckerregulation auf das kardiovaskuläre Risiko (Publikation 2). Die Studienqualität wurde durch OQAQ (Overview Quality Assessment Questionnaire) bewertet. Im Anschluss hatte eine Literaturübersicht das Ziel, wirksame Maßnahmen der Verhältnisprävention sowie Kommunikations-strategien zu identifizieren, um Handlungsempfehlungen abzuleiten, wie politische Entscheidungsträger in verschiedenen Altersgruppen und Settings Diabetes verhindern können (Publikation 3). In einem nächsten Schritt wurden Ansätze der digitalen Diabetesprävention und –versorgung aufgearbeitet. Zur Evaluation von digitalen Interventionen mit mehr als einer aktiven Funktion wurde ein Studienprotokoll entwickelt. Dieses beschreibt die Evaluation einer (hypothetischen) spielbasierten mobilen Applikation zur Gewichtsreduzierung bei übergewichtigen und adipösen Jugendlichen (Publikation 4). Im letzten Schritt wurde ein Umbrella Review (Publikation 5) durchgeführt, um die Wirksamkeit von Telemedizin bei Patienten mit Diabetes, Lipidstoffwechselstörungen und Hypertonie systematisch zu erheben. Potentiell relevante Forschungsarbeiten mussten die Wirksamkeit (effectiveness) von Telemedizin auf klinische Outcomeparameter unter realweltlichen Bedingungen bei mindestens einer der definierten Erkrankungen in Form von systematischen Übersichtsarbeiten und Meta-Analysen auf Basis von RCTs untersucht haben. Ergebnisse von Meta-Analysen und deren Subgruppenanalysen wurden herangezogen, um effektive Funktionen oder andere Charakteristika (z.B. Intensität oder Häufigkeit von Feedback) zu identifizieren. Um das Vertrauen in den Effektschätzer der Subgruppenanalysen zu bewerten, wurde das GRADE-Schema (Grading of Recommendations Assessment, Development and Evaluation) angewandt. Ergebnisse und Schlussfolgerungen: Die standardisierte Befragung zu verfügbaren Versorgungsmodellen von Patienten mit Diabetes ergab, dass das Fehlen nationaler Versorgungsleitlinien, nicht kosteneffektive und nicht-individualisierte Versorgung sowie lange Wartezeiten häufig bemängelt wurden. Für die befragten Patienten waren im Vergleich zu den befragten Leistungserbringern die Patientenschulung, Kommunikation im Behandlungsteam und mit dem Patienten, die Prävention und Gesundheitsförderung, sowie die Verfügbarkeit der Versorgungsdienstleistungen signifikant wichtiger. Die identifizierten unterschiedlichen Prioritäten zwischen den an der Versorgung beteiligten Akteuren legen nahe, diese Präferenzen frühzeitig zu erfassen. Der Umbrella Review zum Potential der Blutzuckerregulation für Verbesserungen kardiovaskulärer Risiken identifizierte 44 Übersichtsarbeiten mit mehrheitlich guter Qualität (OQAQ-Median = 17). Unter Berücksichtigung unterschiedlicher Endpunkte legen die Erkenntnisse nahe, dass sowohl pharmakologische als auch nicht-pharmakologische Interventionen kardiovaskuläre Endpunkte verbessern können. Die Entscheidung für eine Intervention und ihre Intensität sollte neben dem Blutdruck auch das bestehende kardiovaskuläre Risiko zu Beginn der Behandlung berücksichtigen. Leitlinien im Bereich der kardiovaskulären Prävention sollten sowohl pathophysiologische Mechanismen als auch individuelle verhaltensorientierte Präventionsmaßnahmen einbeziehen. Während im Bereich der Verhaltensprävention wirksame Strategien, wie die Steigerung der körperlichen Aktivität und die Anpassung der Ernährungsgewohnheiten, identifiziert wurden, war die verfügbare Evidenz von populationsbasierten Maßnahmen der Verhältnisprävention im durchgeführten Umbrella Review begrenzt und nicht belastbar. Die im Anschluss durchgeführte Literaturübersicht konnte jedoch belastbare Evidenz zur Verhältnisprävention, wie die Besteuerung ungesunder Nahrungsmittel und spezifische Präventionsmaßnahmen in Settings (z.B. Kindergarten, Schule etc.), identifizieren. Diese Ansätze können dazu beitragen, regulatorische Maßnahmen zur Diabetesprävention in verschiedenen Altersgruppen und Settings zu entwickeln. Zur Evaluation einer mobilen digitalen Gesundheitsanwendung mit mehreren Funktionen wurde ein CONSORT-konformes Studienprotokoll für eine monozentrische, zweiarmige, dreifach verblindete, randomisierte, kontrollierte Studie entwickelt. Die Intervention bestand aus einer Smartphone-Applikation, die „Tracking“ und spielerische Anregungen zur Lebensstiländerung verbindet. Die Kontrollgruppe erhielt eine Smartphone-Applikation mit identischem Design, die jedoch ausschließlich Tracking von Gesundheitsinformationen anbietet. Im Rahmen des frühen Wirksamkeitsnachweises scheinen RCTs hilfreich, um die Wirksamkeit einer App bzw. ausgewählter Funktionen klinisch kontrolliert zu testen. Die fünfte Publikation der vorliegenden Dissertation zeigt, dass Telemedizin den HbA1c bei Patienten mit T2D klinisch relevant (≤ -0,5 %) reduzieren kann. Die identifizierten Reduktionsraten sind mit jenen von etablierten lebensstilmodifizierenden und selbst einigen pharmakologischen Interventionen vergleichbar. Extrahierte Subgruppenanalysen legen nahe, dass bestimmte Populations- und Interventionscharakteristika mit einer gesteigerten Wirksamkeit assoziiert sind. Hierzu gehören Interventionen mit relativ kurzer Dauer ( 8,0 %) wurden als Patientencharakteristika identifiziert, bei denen Telemedizin zu klinisch relevanten und signifikanten Verbesserungen des HbA1c führte. Neben diesen Charakteristika sollten zukünftige Leitlinienupdates das geringe Vertrauen in die Effektschätzer, in Form der schlechten GRADE Bewertungen, berücksichtigen. Die vorliegende kumulative Dissertation liefert einen Beitrag zur systematischen Übersicht über wirksame Ansätze der Diabetesprävention und –versorgung. In der Gesamtschau zeigt sich ein Potential für die frühzeitige und strukturierte Berücksichtigung von Patientenpräferenzen. Durch die Aufbereitung und methodische Bewertung der verfügbaren Evidenz zur Wirksamkeit von Telemedizin bei Diabetes und assoziierten Begleiterkrankungen wurden Ansätze für die gezielte Aktualisierung bestehender Leitlinien identifiziert. Es besteht ein Bedarf für methodisch robuste Studien zur Wirksamkeit von Telemedizin in spezifischen Populationen und unter Berücksichtigung der Kombination digitaler Interventionsfunktionen. Die Ergebnisse und identifizierten Forschungsbedarfe haben das Potential, zukünftige Studien zu motivieren.:Inhaltsverzeichnis I Abkürzungsverzeichnis III Abbildungsverzeichnis VI Tabellenverzeichnis VII Liste der entstandenen Publikationen VIII 1 Einführung in die Thematik 1 1.1 Diabetes 1 1.1.1 Epidemiologie 1 1.1.2 Krankheitstypen, Krankheitsstadien und Begleiterkrankungen 2 1.1.3 Diabetesprävention 5 1.1.4 Diabetesversorgung 6 1.2 Evidenzbasierte Medizin 9 1.3 Digitalisierung 14 1.4 Stand der Forschung 15 1.4.1 Unterstützungs- und Versorgungsprobleme 15 1.4.2 Individuelle und populationsbasierte Maßnahmen zur Diabetesprävention 16 1.4.3 Herausforderungen digitaler Diabetesprävention und -versorgung 22 1.5 Zieldefinition und Fragestellung 25 2 Thematischer Zusammenhang und Methodenüberblick 26 3 Individualising Chronic Care Management by Analysing Patients’ Needs – A Mixed Method Approach 28 4 Blood Sugar Regulation for Cardiovascular Health Promotion and Disease Prevention 31 5 What should governments be doing to prevent diabetes throughout the life course? 34 6 Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial 36 7 Mapping the Evidence on the Effectiveness of Telemedicine Interventions in Diabetes, Dyslipidemia, and Hypertension: An Umbrella Review of Systematic Reviews and Meta-Analyses 38 8 Diskussion und Ausblick 41 8.1 Einordnung der Ergebnisse 41 8.2 Limitationen und Methodenkritik 49 8.3 Wissenschaftliche Kontribution und Ausblick 50 9 Schlussfolgerung 51 10 Zusammenfassung 53 11 Summary 57 12 Literaturverzeichnis 60 13 Anhang 110 13.1 Wissenschaftliche Kontribution der Publikationen 110 13.2 Details zu Publikationen als Erstautor 112 13.3 Volltexte der entstandenen Veröffentlichungen 117 13.4 Curriculum Vitae 198 13.5 Danksagung 199 Anlage 1 200 Anlage 2 20

Cross-sectional associations between mothers and children’s breakfast routine : the Feel4Diabetes study

Positive influences of family members have been associated with a high probability of children's daily breakfast consumption. Therefore, the aim of this study was to scrutinize the association of breakfast routines between mothers and their children. The baseline data of the Feel4Diabetes-study was obtained in 9760 children (49.05% boys)-mother pairs in six European countries. A parental self-reported questionnaire gauging the frequency of breakfast consumption and of breakfast ' foods and beverages consumption was used. Agreement in routines of mothers and their children's breakfast consumption was analyzed in sex-specific crosstabs. The relationship of breakfast routine and food groups' consumption between mothers and their children was assessed with analysis of covariance. The highest proportion of children who always consumed breakfast were those whose mothers always consumed it. Children consuming breakfast regularly had a higher intake of milk or unsweetened dairy products and all kind of cereal products (low fiber and whole-grain) than occasional breakfast consumers (p < 0.05). The strong similarity between mothers and children suggests a transfer of breakfast routine from mothers to their children, as a high proportion of children who usually consume breakfast were from mothers also consuming breakfast. All breakfast foods and beverages consumption frequencies were similar between children and their mothers

Longitudinal Associations between Food Parenting Practices and Dietary Intake in Children: The Feel4Diabetes Study

Food parenting practices (FPPs) have an important role in shaping children’s dietary behaviors. This study aimed to investigate cross-sectional and longitudinal associations over a twoyear follow-up between FPP and dietary intake and compliance with current recommendations in 6- to 11-year-old European children. A total of 2967 parent-child dyads from the Feel4Diabetes study, a randomized controlled trial of a school and community-based intervention, (50.4% girls and 93.5% mothers) were included. FPPs assessed were: (1) home food availability; (2) parental role modeling of fruit intake; (3) permissiveness; (4) using food as a reward. Children’s dietary intake was assessed through a parent-reported food frequency questionnaire. In regression analyses, the strongest cross-sectional associations were observed between home availability of 100% fruit juice and corresponding intake (β = 0.492 in girls and β = 0.506 in boys, p < 0.001), and between parental role modeling of fruit intake and children’s fruit intake (β = 0.431 in girls and β = 0.448 in boys, p < 0.001). In multilevel logistic regression models, results indicated that improvements in positive FPPs over time were mainly associated with higher odds of compliance with healthy food recommendations, whereas a decrease in negative FPP over time was associated with higher odds of complying with energy-dense/nutrient-poor food recommendations. Improving FPPs could be an effective way to improve children’s dietary intake.European Union’s Horizon 2020Aragón’s Regional Government (Diputación General de Aragón, DGA

Accuracy of 1-Hour Plasma Glucose During the Oral Glucose Tolerance Test in Diagnosis of Type 2 Diabetes in Adults : A Meta-analysis

OBJECTIVE One-hour plasma glucose (1-h PG) during the oral glucose tolerance test (OGTT) is an accurate predictor of type 2 diabetes. We performed a meta-analysis to determine the optimum cutoff of 1-h PG for detection of type 2 diabetes using 2-h PG as the gold standard. RESEARCH DESIGN AND METHODS We included 15 studies with 35,551 participants from multiple ethnic groups (53.8% Caucasian) and 2,705 newly detected cases of diabetes based on 2-h PG during OGTT. We excluded cases identified only by elevated fasting plasma glucose and/or HbA(1c). We determined the optimal 1-h PG threshold and its accuracy at this cutoff for detection of diabetes (2-h PG >= 11.1 mmol/L) using a mixed linear effects regression model with different weights to sensitivity/specificity (2/3, 1/2, and 1/3). RESULTS Three cutoffs of 1-h PG, at 10.6 mmol/L, 11.6 mmol/L, and 12.5 mmol/L, had sensitivities of 0.95, 0.92, and 0.87 and specificities of 0.86, 0.91, and 0.94 at weights 2/3, 1/2, and 1/3, respectively. The cutoff of 11.6 mmol/L (95% CI 10.6, 12.6) had a sensitivity of 0.92 (0.87, 0.95), specificity of 0.91 (0.88, 0.93), area under the curve 0.939 (95% confidence region for sensitivity at a given specificity: 0.904, 0.946), and a positive predictive value of 45%. CONCLUSIONS The 1-h PG of >= 11.6 mmol/L during OGTT has a good sensitivity and specificity for detecting type 2 diabetes. Prescreening with a diabetes-specific risk calculator to identify high-risk individuals is suggested to decrease the proportion of false-positive cases. Studies including other ethnic groups and assessing complication risk are warranted.Peer reviewe

Video-based smartphone app (‘VIDEA bewegt’) for physical activity support in German adults: a single-armed observational study

Objectives The primary objective of this study was to investigate the effect of the video-based smartphone app ‘VIDEA bewegt’ over eight programme weeks on physical activity in German adults. - Design The study used a single-arm observational design, assessing the app’s effectiveness under real-life conditions. Data were collected from July 2019 to July 2020. - Setting The app is enabling users to access video-based educational content via their smartphone. A clinical visit or in-person contact was not required. Participants All individuals registered in the freely available app were invited to take part in the study. - Interventions The app aims to increase physical activity in everyday life. It combines educative videos on lifestyle-related benefits and instructional videos of strength and endurance exercises to do at home with motivational components like goal setting, documentation of progress and personalised messages. - Primary and secondary outcome measures Primary outcomes were physical activity based one MET minutes per week (metabolic equivalent) and step numbers. Secondary outcomes included physical self-efficacy (motivational, maintenance, recovery self-efficacy), health-related quality of life: Mental Health Component Summary score and Physical Health Component Summary score. - Results Of 97 people included in the data analysis, 55 successfully completed the programme and all questionnaires. Significant increases over eight programme weeks (between T0 and T2) were observed in physical activity based on MET minutes per week, health-related quality of life, and recovery self-efficacy. Time spent sitting and body mass index significantly decreased for those completing the programme. Conclusions Although significant benefits of physical activity were observed following a complete-case analysis, results should be dealt with caution. Studies with a larger and less heterogeneous sample and robust study designs able to measure causal effects would be desirable. Trial registration number DRKS00017392

A qualitative study of users’ experiences after 3 months: the first Rwandan diabetes self-management Smartphone application “Kir’App”

Background: Owing to the increasing popularity of smartphones in Rwanda, almost 75% of the entire population currently has access to the internet. Although it has been shown that smartphone applications can support diabetes self-management, there was no diabetes selfmanagement application available in Rwanda until April 2019. Based on the findings of a prior study assessing the needs and expectations of potential users, ‘Kir’App’ was developed to fill that void. The aim of this study was to evaluate users’ experiences after 3 months of use of the first Kir’App prototype. Methods: The participants of the previous study were recruited to take part in the current study. Semi-structured, in-depth, face-to-face interviews were conducted. Findings were analysed thematically using Mayring’s method of qualitative content analysis. Both deductive and inductive approaches were used to analyse transcripts according to the original categories and subcategories of the previous study. Results: A total of 14 people with either type 1 or type 2 diabetes participated in the study. Age of participants ranged from 19 to 70 years, with a mean age of 34.4 years. Seven of the eight original themes and one additional theme were subjoined: diabetes education and desired information provision; increased diabetes knowledge and awareness; monitoring and reminder functions; nutrition; physical activity; coping with burden of disease; app features; use behaviour and usability. Overall, participants stated that the app increased their diabetes knowledge and assisted them with their diabetes self-management. Conclusions: We found that the first prototype of Kir’App meets the overall needs and expectations of participating Rwandan diabetics. Having followed a strict user-centred design process, their qualitative insights will help to further improve the app

Impact of a Digital Lifestyle Intervention on Diabetes Self-Management: A Pilot Study

The aim of this study was to provide preliminary evidence on the impact of the digital health application Vitadio on improving glycemic control in patients with type 2 diabetes mellitus. This was a 3-month, prospective, multicenter, open-label trial with an intraindividual control group. Participants received a digital lifestyle intervention. HbA1c levels were observed at 3 time points: retrospectively, at 3 months before app use; at baseline, at the start of usage; and 3 months after the start of use. In addition, changes in other metabolic parameters (fasting glucose, body weight, and waist circumference), patient reported outcomes (quality of life, self-efficacy, and depression), and data generated within the app (frequency of use, steps, and photos of meals) were evaluated. Repeated measures analysis of variance with the Bonferroni correction was used to assess the overall difference in HbA1c values between the intervention and the intraindividual control group, with p n = 42) were 57 ± 7.4 years old, 55% male, and with a mean baseline HbA1c of 7.9 ± 1.0%. An average HbA1c reduction of −0.9 ± 1.1% (p 2), waist circumference (−5.7 ± 15 cm), and fasting glucose (−0.6 ± 1.3 mmol/L). The digital therapy achieved a clinically meaningful and significant HbA1c reduction as well as a positive effect on metabolic parameters. These results provide preliminary evidence that Vitadio may be effective in supporting patient diabetes management by motivating patients to adopt healthier lifestyles and improving their self-management