BACKGROUND In 2010, glycated haemoglobin A1c (HbA1c) was officially recommended as a screening tool to diagnose type 2 diabetes mellitus (T2DM) and pre-diabetes, with cut-off points 6.5% and 5.7% to 6.4% respectively. The implications of using the HbA1c criterion, compared to the general diagnostic criteria: fasting glucose test (FPG) and oral glucose tolerance test (OGTT), is however still being debated. OBJECTIVES The objectives of this study were to evaluate and compare the pooled prevalence of type 2 diabetes mellitus (T2DM) and pre-diabetes, as measured by the Haemoglobin A1c (HbA1c) test, or the fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT). Secondly, to determine and compare the diagnostic test characteristics (sensitivity, specificity) of these tests. METHODS Published papers, with a cross sectional study design, were selected for a systematic review and meta-analysis. The search strategy was an electronic review of journal articles listed on MEDLINE, PubMed and Google scholar between 1996 and 2012. Reference lists were checked, journals were hand searched and experts were contacted when necessary. Initially all studies related to the validation of HbA1c as a tool to detect pre-diabetes or T2DM in humans, published in English, were examined. Studies were excluded if they did not meet the above mentioned criteria, and/or were conducted with pregnant women. Further analysis was done if FPG or OGTT was compared to HbA1c. The diagnosis of diabetes had to have been based on ADA or WHO criteria. These criteria are: HbA1c 5.7%-6.4% for pre-diabetes and >=6.5% for T2DM; FPG 5.6mmol-7mmol/l for pre-diabetes and >=7mmol/l for T2DM; OGTT 7.8mmol-11.1mmol/l for pre-diabetes and >=11.1mmol/l for T2DM). The OGTT and FPG tests were used as the reference tests and the prevalence reflected as a positive or negative proportion. The sensitivity and specificity of HbA1c >=6.5% among cases defined by OGTT or FPG should have been reported, or it was possible to calculate these from the data provided. Study results relating to diagnostic accuracy were extracted and synthesized using multivariate random effects meta-analysis methods. This study focused on patients who were suspected of having T2DM, from two sub-groups (a community-based group and a high-risk group) to compare the detection rate of HbA1c with FPG and OGTT. / Dissertation (MSc)--University of Pretoria, 2014. / lk2014 / School of Health Systems and Public Health (SHSPH) / MSc / Unrestricted

Bakgrund: Diabetes Mellitus Typ 2 (DMT2) är en av våra vanligaste folksjukdomar med olika allvarliga senkomplikationer där hjärt-/kärlsjukdomar är den vanligaste dödsorsaken. Kostbehandling av sjukdomen är en av de viktigaste egenvårdsåtgärderna. 2008 godkände Socialstyrelsen lågkolhydratkost som kostrekommendation till DMT2-patienter.Syfte: Studiens syfte var att undersöka för- och nackdelar med lågkolhydratkost som kostrekommendation till DMT2-patienter.Metod: Studien är en systematisk litteraturstudie baserad på databassökningar. Tretton artiklar värderades, varav tio bedömdes hålla tillräckligt hög kvalitet för inklusion. Resultatet kopplades till Orems egenvårdsteori.Resultat: Fördelarna som studien visade på sammanfattades i fyra teman; viktminskning, sänkta glukos- och insulinhalter, förbättrade lipidvärden och minskad läkemedelsanvändning. De identifierade nackdelarna sammanfattades i två teman; compliance och kostrekommendation.Diskussion: Lågkolhydratkost har flera stora medicinska fördelar jämfört med lågfettkost. Nackdelarna är kopplade till problem att följa dieten på längre sikt och till avsaknaden av enhetliga kostråd. Mer forskning på dessa områden krävs samt en fastställd rekommendation från Socialstyrelsen.Nyckelord: Diabetes Mellitus typ 2, egenvård, Hba1c, kostrekommendationer, lipidvärde, lågkolhydratkost, viktminskning. / Background: Type 2 Diabetes Mellitus (DMT2) is one of our most common diseases with several serious complications, where cardiovascular disease is the most common cause of death. Dietary treatment is one of the most important parts of the patient’s management of the disease. In 2008 the National Swedish Board of Health and Welfare approved of Low Carbohydrate Diet to be used as dietary recommendation for patients with DMT2.Aim: The aim of the study was to study the benefits and the setbacks with low carbohydrate diets as dietary recommendation for patients with DMT2.Method: The study is a systematic literary study based on articles found in the PubMed database. Thirteen articles were valued and ten of them were considered to be of high enough quality to be included in the study. The result of the study was discussed with regard to Orem’s nursing theory.Result: The benefits of the study were sorted into four themes; weight loss, lowered levels of glucose and insulin, improved lipid levels and reduced use of anti-diabetic medication. The identified setbacks were sorted into two themes; compliance and dietary advice.Discussion: Low Carbohydrate Diets has several big medical benefits compared to a Low Fat Diet. The setbacks are connected to long-term adherence of dietary advice and the lack of standard dietary advice. More research in these areas is duly needed, together with a set recommendation from the National Swedish Board of Health and Welfare.Keywords: Type 2 Diabetes Mellitus, Dietary Recommendation, HbA1c, lipid levels, Low Carbohydrate Diet, Self-Care, weight loss.

Typ 2 diabetes är en kronisk sjukdom som inte bara är en folksjukdom i Sverige utan även ett globalt problem. Den drabbar främst äldre personer och andra riskfaktorer är bl a övervikt, bukfetma som i många fall orsakats av felaktig kost och brist på fysisk aktivitet. Dessa faktorer påverkar även utveckling av sjukdomen vad gäller kroniska komplikationer som orsakas av skador på både stora och små blodkärl. Syftet med denna litteraturstudie var att studera effekten av kost och fysisk aktivitet på personer med typ 2 diabetes och därmed påverkan på framtida kroniska komplikationer. Metoden var en systematisk litteraturstudie bestående av 15 vetenskapliga artiklar baserade på kvantitativ forskning. Flera studier visade att en hälsosam kost och regelbunden fysisk aktivitet kan förhindra komplikationer genom att ge positiv effekt på exempelvis insulinkänslighet, blodtryck, HbA1c, bukfetma och övervikt som i sin tur är riskfaktorer för kroniska komplikationer. / Type 2 diabetes is a chronic national disease in Sweden but also a global problem. It mainly affects the elderly, those that are overweight and/or have significant abdominal fatness. In many cases, the aforementioned, are caused by physical inactivity and lack of a healthy diet. These factors also affect the progress of the disease when it comes to chronic complications that are caused by injuries in both large and small blood vessels. The aim of this study is to examine the effect of physical activity and diet on type 2 diabetes patients and the affectability on chronic complications. The method used was a systematic literature review consisting of 15 scientific articles based on quantitative studies. Several studies showed that a healthy diet and physical activity can prevent complications by adding a positive effect on insulin sensitivity, blood pressure, HbA1c, abdominal fatness and body weight.

No description available.

Den orala hälsan kan påverkas av flera faktorer, däribland olika systemsjukdomar. I Sverige ser man en ökning av T2D som är en vällevnadssjukdom. T2D tycks ha en inverkan på den orala hälsan, framförallt hos individer med parodontit. Syftet med detta examensarbete var att redovisa relationen mellan T2D och parodontit. Syftet var även att beskriva vilken effekt behandling av parodontit och T2D kan tänkas ha på respektive sjukdom. Examensarbetet har genomförts som en litteraturstudie. Artiklar hämtades från databasen PubMed. Det gjordes flera urval som slutligen genererade 17 originalartiklar. Det tycks finnas en komplex tvåvägsrelation mellan parodontit och T2D. Flera studier visar att T2D kan öka risken för parodontit. Dock kan man inte fullt ut förklara pardontitens påverkan på T2D eftersom olika studier har visat motsägande resultat. Då studierna säger emot varandra bör berörda individer informeras om riskerna vid parodontit och T2D. Det vore önskvärt att samarbetet mellan sjukvård och tandvård förbättras. För att fullständigt klargöra tvåvägsrelationen mellan T2D och parodontit krävs fler studier inom området.

Inledning: Diabetes typ 2 är en metabol sjukdom som har ökat i hela världen. Diabetes medför stora hälsoproblem som kan leda till förtidig död och funktionshinder. Fysisk aktivitet är en faktor som kan förändra diabeteskomplikationer och förbättra människors möjlighet att hantera symptomen av diabetes. Syftet med litteraturöversikten är att identifiera effekterna av fysisk aktivitet vid diabetes typ 2 bland vuxna. Metod: Denna studie är en litteraturöversikt där tio originalartiklar har använts för att genomföra denna studie och fyra teman framkom som förklarar effekten av fysisk aktivitet vid diabetes typ 2. Resultat: Olika träningsform såsom aerob- kombinerad- och styrketräning samt effekt av medicinering vid diabetes typ 2 visar att diabetes kan förbättras genom fysisk aktivitet. Diskussion: Fysisk aktivitet anses som viktigt för att bekämpa symptom av diabetes typ 2. Olika former av träning förbättrar diabetes typ 2. Mer forskning behövs för att bidra till kliniska rekommendationer. / Introduction: Diabetes type 2 is a metabolic disease that has increased all over the world. Diabetes causes huge health problems that lead to premature death and disabilities. Physicalactivity is a factor that can improve diabetes complications and ameliorate the management of the symptoms related to diabetes. The aim of this literature review is to identify effects of physical activity in diabetes type 2 among adults. Methods: This study is a literature review where ten original articles were used to carry out this study and five themes were developed to explain the effects of physical activity in diabetes type 2. Results: Different types of training such as aerobic training, combined training, resistance training and also the effect of medicine showed that diabetes type 2 can be improved through physical activity. Discussion: Physical activity is important to fight the symptoms of diabetes type 2. Different types of training improve in various ways diabetes type 2. More researches are needed to contribute to clinical recommendations.

La prévalence du diabète ne cesse d’augmenter et la détection de sujets à risque de développer cette maladie reste une préoccupation importante afin qu’un programme de prévention leur soit proposé. Le dosage de l’HbA1c est utilisé pour l’évaluation de l’efficacité du traitement pris par les diabétiques. Il n’était pas utilisé pour le diagnostic des dysglycémies car les méthodes de ce dosage n’étaient pas standardisées. Actuellement l’IFCC (International Federation of Clinical Chemistry) propose une nouvelle méthode de référence pour cette mesure, et l’OMS (Organisation Mondiale de la Santé) a intégré ce paramètre dans les critères diagnostiques du diabète. but Evaluer la capacité de l’HbA1c à prédire un diabète incident, chercher des seuils, d’HbA1c, de GAJ et de glycémie deux heures (G2H) après un test d’hyperglycémie provoquée par voie orale (HGPO), au delà desquels les sujets sont plus à risque de développer un diabète incident et, enfin, étudier l’influence du tabac sur les variations de ces mesures. Méthodes Pour l’évaluation de la prédiction du diabète et la recherche de seuils, nous avons utilisé les données de l’étude australienne AusDiab, de l’étude danoise Inter99 et de l’étude française D.E.S.I.R. avec plus de 5500, 4500 et 3550 sujets, respectivement. Dans la troisième partie, nous avons utilisé les données du projet DETECT-2 (12 études, 26 000 sujets), ainsi que celles des études françaises D.E.S.I.R. et TELECOM (3700 sujets). Les distributions de l’HbA1c dans les trois premières études étaient différentes, nous avons donc, dans les deux premières parties d’analyses, ajusté les moyennes d’HbA1c à l’inclusion et après le suivi. Nous avons utilisé un modèle logistique pour la comparaison du pouvoir prédictif de l’HbA1c et de GAJ ; l’intervalle de confiance des Odds Ratios (ORs) à été obtenu par bootstrap. Pour rechercher les seuils de prédiction du diabète, nous avons comparé le modèle logistique (avec la variable glycémique) sans seuil au modèle avec seuil. Enfin, nous avons utilisé un modèle linéaire mixte pour évaluer la différence entre les moyennes d’HbA1c, de GAJ et de G2H en fonction du tabagisme, en attribuant un effet aléatoire à la variable ‘centre’. Résultats Avant ajustement des moyennes d’HbA1c, l’incidence du diabète (défini par la prise de traitement antidiabétique, une HbA1c≥6.5% ou une GAJ≥7mmol/l) était de 3.1% dans AusDiab, 2.7% dans Inter99 et 2.5% dans D.E.S.I.R. Les sujets dépistés comme étant diabétiques par l’HbA1c et par la GAJ n’étaient pas toujours les mêmes. L’incidence estimée du diabète augmente bien avec l’augmentation du taux de l’HbA1c et de la GAJ à l’inclusion. Pour chaque critère, l’aire sous la courbe de ROC (Receiver Operating Characteristic) était supérieure à 0.80 témoignant d’une bonne discrimination des deux tests entre les diabétiques incidents et les non diabétiques et le test de Hosmer-Lemeshow témoigne d’une bonne adéquation des modèles utilisés (p>0.05). Dans les trois populations, les ORs qui mesurent l’association entre les taux d’HbA1c et de GAJ et la survenue du diabète étaient presque toujours supérieurs pour l’HbA1c. Les seuils d’HbA1c et de GAJ au-delà desquels les sujets étaient plus à risque de développer un diabète variaient en fonction de la définition du diabète incident sauf pour l’HbA1c dans l’étude D.E.S.I.R. (5.3%) et la GAJ dans l’étude AusDiab (5.5mmol/l). Enfin, la moyenne d’HbA1c chez les fumeurs actuels était 0.10%(0.08,0.12) plus élevée que chez ceux qui n’ont jamais fumé ; la moyenne de G2H était -0.44(-0.51,-0.36) moins élevée chez les fumeurs actuels que chez ceux qui n’ont jamais fumé.Conclusion Ces résultats soulignent : 1) l’importance de l’utilisation de l’HbA1c comme critère diagnostique de dysglycémies, 2) la nécessité de mieux explorer les limites inférieures des stades intermédiaires qui précèdent la survenue du diabète, 3) l’importance de prendre en considération les facteurs qui peuvent influencer les taux d’HbA1c / The increasing prevalence of diabetes worldwide makes the detection of people at risk of developing diabetes a major concern, so that they can benefit from diabetes prevention programs. HbA1c is used to evaluate the effectiveness of treatment taken by diabetic patients. HbA1c had not been used to diagnose dysglycemia because the assay methods were not standardized. The International Federation of Clinical Chemistry has proposed a reference method, and in 2011 the World Health Organization included HbA1c as one of the criteria for the diagnosis of diabetes. aims: 1) To evaluate the ability of HbA1c to predict incident diabetes compared with fasting plasma glucose (FPG); 2) to find thresholds for HbA1c, FPG and two hour plasma glucose (G2H) after an oral glucose tolerance test (OGTT) beyond which subjects are more at risk for developing incident diabetes and finally; 3) to study the influence of smoking on HbA1c, FPG and G2H.Methods: Several populations were studied. To evaluate the prediction of diabetes and the search for thresholds, we used data from the Australian study (AusDiab), a Danish study (Inter99) and a French study (D.E.S.I.R.) with respectively more then 5500, 4500 and 3550 participants. In the third part, we used data from the DETECT-2 consortium (12 studies with more than 26 000 men and women) and from two French studies: D.E.S.I.R. and TELECOM (with more than 3700 participants). The distribution of HbA1c in AusDiab, Inter99 and D.E.S.I.R. differed, so in the first two parts of this thesis, we adjusted HbA1c so that all three studies had the same mean HbA1c at baseline and the same mean HbA1c at follow-up. We used a logistic model to quantify the predictive ability of HbA1c and FPG for diabetes, and then derived confidence intervals for the difference in Odds Ratios (ORs) by bootstrap. To search for thresholds to predict incident diabetes, based on HbA1c, FPG and G2H at inclusion, we compared logistic regression models that were linear in the glycaemic variable, without a threshold, with a spline model with a threshold. Linear mixed models with ‘centre’ as a random variable, were used to assess the difference between the means of HbA1c, FPG and G2H in current-, ex- and never-smokers.Results: With unadjusted HbA1c data, the incidence of diabetes (defined by treatment, HbA1c≥6.5% or FPG≥7 mmol/l) was 3.1% in AusDiab, 2.7% in Inter99 and 2.5% in D.E.S.I.R.. Subjects detected as having diabetes by HbA1c and FPG were not always the same. The incidence of diabetes increased with increasing HbA1c and FPG at baseline. For each test, the area under the Receiver Operating Characteristic curve was greater than 0.80, indicating good discrimination for these two measures between those with and without incident diabetes, and the Hosmer-Lemeshow test indicated that the models fitted well (p>0.05). In all three populations, the ORs measuring the association between HbA1c and FPG and the development of diabetes were almost always higher for HbA1c than for FPG. The thresholds of HbA1c and FPG above which the incidence of diabetes were higher, varied according to the definition of incident diabetes - except for HbA1c in D.E.S.I.R. (always 5.3%) and for FPG in AusDiab (always 5.5mmol/l). Finally, in current-smokers, the mean HbA1c was 0.10%(0.08,0.12) higher than in never-smokers; the mean G2H was 0.44( 0.51,-0.36) lower in current-smokers than in never-smokers. Conclusion: The results that we found emphasize: 1) the importance of using HbA1c as a diagnostic criterion for dysglycemia, as those diagnosed diabetic by HbA1c did not have always an FPG ≥ 7 mmol/l, 2) the need to better explore the lower limits of the “pre-diabetic” stage as the thresholds of HbA1c, FPG and 2H-PG that we found were lower than those used in clinical practice, 3) the importance to consider factors that may influence HbA1c and G2H, such as smoking.

Hämoglobin-A1c (HbA1c) ist ein Hämoglobin (Hb)-Subtypus, der durch nicht-enzymatische Glykierung des N-terminalen Valinrestes der Hämoglobin-beta-Kette entsteht. Das gemessene Verhältnis von HbA1c zum Gesamt-Hämoglobin (5-20 % bei Diabetikern) repräsentiert den Mittelwert der Blutglucosekonzentration über einen zweimonatigen Zeitraum und stellt zur Beurteilung der diabetischen Stoffwechsellage eine Ergänzung zur Akutkontrolle der Glukosekonzentration dar.<br /> Ziel der vorliegenden Arbeit war es, einen amperometrischen Biosensor für die Bestimmung des medizinisch relevanten Parameters HbA1c zu entwickeln. Durch Selektion geeigneter Bioerkennungselemente und deren Immobilisierung unter Erhalt der Bindungsfunktion für die Zielmoleküle Hämoglobin bzw. HbA1c wurden spezifische, hochaffine und regenerationsstabile Sensoroberflächen geschaffen. Für die Entwicklung des HbA1c-Biosensors wurden zwei Konzepte - Enzymsensor und Immunosensor - miteinander verglichen. <br /> Die enzymatische Umsetzung von HbA1c erfolgte mit der Fructosylamin Oxidase (FAO) aus Pichia pastoris N 1-1 unter Freisetzung von H2O2, welches sowohl optisch über eine Indikatorreaktion als auch elektrochemisch nach Einschluss der FAO in PVA-SbQ und Fixierung des Immobilisats vor einer H2O2-Elektrode nachgewiesen wurde. Die Kalibration des Enzymsensors mit der HbA1c-Modellsubstanz Fructosyl-Valin ergab Nachweisgrenzen, die ausserhalb des physiologisch relevanten HbA1c-Konzentrationsbereich lagen. Aus der Umsetzung von glykierten Peptiden mit einer nicht HbA1c analogen Aminosäurensequenz, z.B. Fructosyl-Valin-Glycin wurde zudem eine geringe HbA1c-Spezifität abgeleitet.<br /> Für den Immunosensor wurden zwei heterogene Immunoassay-Formate unter Verwendung von hochaffinen und spezifischen Antikörpern in Kombination mit Glucose Oxidase (GOD) als Markerenzym zum Nachweis von HbA1c untersucht. Beim indirekt-kompetitiven Immunoassay wurde anstelle des kompletten HbA1c-Moleküls das glykierte Pentapeptid Fructosyl-Valin-Histidin-Leucin-Threonin-Prolin (glkPP) als Kompetitor und Affinitätsligand immobilisiert und so eine regenerierfähige Oberfläche geschaffen. Beim Sandwich-Immunoassay wurde im ersten Schritt Gesamt-Hämoglobin an die mit Haptoglobin (Hp) modifizierte Festphase angereichert und im zweiten Schritt der gebundene HbA1c-Anteil nachgewiesen. <br /> Für die Konstruktion des HbA1c-Immunosensors wurden Affinitätsmatrizen durch Modifizierung von Cellulose-Dialysemembranen mit glkPP bzw. Hp hergestellt. Grundlegend studiert wurde die Aktivierung der Cellulose-Membranen mit 1,1'-Carbonyldiimidazol (CDI) und 1-Cyano-4-dimethylaminopyridintetrafluoroborat (CDAP) als Aktivierungsagenzien. Eine gerichtete Immobilisierung der Liganden wurde realisiert, indem glkPP über dessen C-Terminus (einzige Carboxylatgruppe) und Hp über dessen periodat-oxidiertem Kohlenhydratrest an die amino- oder hydrazidfunktionalisierte Membranen kovalent gekoppelt wurden. <br /> Mit dem Einsatz der glkPP- und Hp-modifizierten Membranen in der elektrochemischen Messzelle war erstmalig der biosensorische Nachweis von HbA1c möglich. Als Transduktor diente eine Pt-Elektrode, an der das von der GOD generierte H2O2 umgesetzt und ein mit der HbA1c-Konzentration korrelierendes Stromsignal erzeugt wurde. Die Immunosensoren zeigten Ansprechzeiten von 3 s. Mit dem Immunosensor auf Basis des indirekt-kompetitiven Testprinzips wurde eine Kalibrationskurve für HbA1c im Bereich von 0,25-30 &#181;g/ml (3,9-465 nM, CV 3-9 %) mit Assayzeiten von 60 min und mit dem Immunosensor im Sandwich-Format eine Kalibrationskurve im Bereich von 0,5-5 &#181;g/ml (7,8-78 nM; 5-50 % HbA1c vom Gesamt-Hb, CV 6-10 %, 3 h) aufgenommen. / Hemoglobin-A1c (HbA1c) is a hemoglobin subtype formed by non-enzymatic reaction of glucose with the N-terminus of the beta-polypeptide chains. As it reflects the glycemic status of diabetics over the preceding 8-12 weeks, the determination of HbA1c has become an established procedure in the management of diabetes mellitus. It is measured as the percentage of total hemoglobin. Up to 5 % HbA1c are considered as normal whereas in diabetic subjects it could be elevated from 5-20 %. In addition to amperometric biosensors for glucose self monitoring which have been successfully applied in diabetes management, biosensors for HbA1c would be an useful supplement for a comprehensive diabetes control. <br /> <br /> Objective of this work was to develop and compare amperometric biosensors for determination of HbA1c based on enzymatic and immunochemical methods. <br /> <br /> For the enzyme based HbA1c assay a novel fructosamine oxidase (FAO) derived from marine yeast Pichia pastoris, strain N1-1 was utilized. It recognizes and oxidatively degrades fructosyl-valine (FV) which corresponds to the glycated N-terminus of the beta-chain of HbA1c and therefore is regarded as a model compound for HbA1c. Hydrogen peroxide which is liberated by the FAO during FV conversion was indicated optically in a horseradish peroxidase (POD) coupled reaction and electrochemically. For the biosensor the FAO was embedded in polyvinyl alcohol-stylbazole (PVA-SbQ) and fixed it in front of a Pt-electrode. So far, the measuring range of FV did not cover the clinically relevant range of HbA1c. Low specificity was assumed since enzyme activity also was obtained with glycated peptides, e.g. fructosyl-valine-glycine, not corresponding to the glycated N-terminus of the hemoglobin-beta-chain.<br /> <br /> For the immunosensor two immunoassays formats - heterogeneous sandwich and heterogeneous competitive - were tested. The assays were designed as follows: The competitive immunoassay was based on the immobilized synthetic glycated pentapeptide fructosyl-valine-histidine-leucine-threonine-proline (glkPP) utilized as HbA1c analogue. The peptide has an amino acid sequence corresponding to the N-terminus of the hemoglobin beta-chains and is capable for competition together with the HbA1c of the sample for the amount of a glucose oxidase (GOD)-labelled anti-HbA1c antibody. In the sandwich-type assay haptoglobin (Hp), a natural hemoglobin binding molecule with antibody characteristic properties, was used as bioreceptor for enrichment of total hemoglobin onto the surface. In a subsequent step the HbA1c fraction was quantified by a GOD-labelled HbA1c specific antibody. <br /> <br /> Cellulose dialysis membrane was used as the solid support for immobilization of Hp and glkPP near the sensor surface. For activation of the membrane two reagents, 1,1&prime;-carbonyldiimidazole (CDI) and 1-cyano-4-dimethylamino pyridinium tetrafluoroborate (CDAP), were compared with respect to the degree of activation and coupling efficiency. Site-directed immobilization of Hp and glkPP was achieved by coupling Hp via its carbohydrate residue and glkPP via its C-terminus to the activated membrane using a bis-amine or bis-hydrazide spacer. <br /> <br /> The affinity membranes were placed in front of a modified Clark-type hydrogen peroxide electrode in an electrochemical measuring cell and HbA1c analysis was carried out within the stirred cell. Detection of the bound GOD-label was achieved by measurement of the electrocatalytic oxidation of hydrogen peroxide at +600 mV vs. Ag/AgCl. The indication was done in only 3 s. For the competitive principle a typical inhibition curve with a linear range between 0,25-30 &#181;g/ml (3,9-465 nM, CV 3-9 %, 60 min per sample) HbA1c was obtained. Due to the high functional stability of the peptide multiple regeneration of the affinity surface was possible without loss of binding capacity. With the sandwich assay configuration the clinically relevant range could easily be covered (calibration curve: 5-50 % HbA1c corresponding to 7,8-78 nM, CV 6-10 %, 3 h per sample).

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.

Mental health problems are increasing in Swedish adolescents and mortality rates are higher in this age group than among younger. 10-20% of all adolescents suffer from a chronic medical condition (CC). Few protective factors (PF) and clustering of health-risk behaviours (HRB) are frequent among adolescents with CCs. One of the most common CC in Swedish adolescents is type 1 diabetes mellitus (T1DM). Metabolic control often deteriorates during adolescence, especially in girls. Poor metabolic control is associated with increased risk for long-term complications, of which cognitive problems are common. However, the implication of cognitive/executive problems in patients with T1DM has not been sufficiently studied. Neither has the impact of neurodevelopmental problems (NDP), such as ADHD, on HRB in adolescents with CCs been analysed. Methods: In paper I and II the questionnaire ”Life and Health in Youth” was distributed to all students in year nine and year two of the upper secondary school in the county of Sörmland, 2008 (n=5771) and 2011 (n=5550). Adolescents with CCs were compared to healthy peers with regard to PFs and HRBs. In paper III, the ”Five to Fifteen” questionnaire was used in 175 paediatric patients with T1DM. Patients with indications of NDPs were compared with patients without such problems with regard to metabolic control. In paper IV, the BRIEF questionnaire and the ADHD Rating Scale as well as data from the Swedish Childhood Diabetes Registry was used in 241 adolescents with T1DM. Patients with indications of executive problems were compared with patients without such problems with regard to diabetes control. Results: CCs were associated with few PFs and clustered HRBs. The combination of CCs and low numbers of PFs was found to be associated with an increased risk of clustered HRBs. In the presence of coexisting ADHD the pattern of few PFs and clustering of HRBs was aggravated. ADHD was more common among adolescents with other CCs. Definite memory and learning problems as well as mild executive problems were associated with poor metabolic control, especially among adolescents. Executive problems were also associated with many outpatient visits and low physical activity. Girls with T1DM tended to self-report executive problems to a larger extent than boys, while parents more often reported these problems in boys. Conclusion: Knowledge about factors influencing treatment adherence and life in general is essential in the work with chronically ill adolescents. Focus must be put on enhancing PFs in order to avoid HRBs. Identification of coexisting NDPs, such as ADHD, is crucial, since such problems can adversely influence treatment adherence, HRBs and school achievements