Use of Sensors in the Treatment and Follow-up of Patients with Diabetes Mellitus

Glucose control is the cornerstone of Diabetes Mellitus (DM) treatment. Although self-regulation using capillary glycemia (SRCG) still remains the best procedure in clinical practice, continuous glucose monitoring systems (CGM) offer the possibility of continuous and dynamic assessment of interstitial glucose concentration. CGM systems have the potential to improve glycemic control while decreasing the incidence of hypoglycemia but the efficiency, compared with SRCG, is still debated. CGM systems have the greatest potential value in patients with hypoglycemic unawareness and in controlling daily fluctuations in blood glucose. The implementation of continuous monitoring in the standard clinical setting has not yet been established but a new generation of open and close loop subcutaneous insulin infusion devices are emerging making insulin treatment and glycemic control more reliable

Proposing Adaptive Insulin Dosage For Type 1 Diabetes By Fuzzy-based Controller

Tez (Yüksek Lisans) -- İstanbul Teknik Üniversitesi, Fen Bilimleri Enstitüsü, 2013Thesis (M.Sc.) -- İstanbul Technical University, Institute of Science and Technology, 2013Bu çalışmada, Tip 1 diyabet hastaları için insülin dozları öneren ve kan şekeri düzeylerindeki değişikliklere uyum sağlayabilen kapalı döngü bir kontrol sistemi önerilmektedir. Diğer çalışmalardan farklı olarak, önerilen bu sistem, hastaya ait, ard arda alınmış üç kan şekeri ölçüm değerini karşılaştırarak, hastaya kan şekeri düzeyini normal sınırlarda tutmaya yardımcı olacak insülin dozlarını hesaplar. Önerilen bu sistem gönüllü gerçek bir Tip 1 diyabet hastası üzerinde de test edilmiştir. Böylelikle hastanın normal tedavisinde kullandığı insülin miktarları ile sistem tarafından önerilen insülin miktarları karşılaştırılmıştır. Buna ek olarak, sistem farklı kan şekeri profilleri üzerinde denenerek, değişime uyum sağladığı ve tutarlı sonuçlar ürettiği gözlemlenmiştir. Böyle bir kontrol sisteminin tasarımı için en yaygın yapay zekâ tekniklerinden olan Bulanık Mantık tekniği kullanılmıştır. Bu amaçla, tasarlanan kontrol sistemi FIS editörü kullanılarak, MATLAB programlama dili ortamında gerçekleştirilmiştir.Emre ÇANAYAZ This study presents an adaptive closed loop system that proposes insulin dosage to regulate the blood glucose level of Type 1 diabetes patients. Developed prototype system contains of two Mamdani–type fuzzy logic controllers, database files with patient information, response of the system is stored, and insulin on board module prevents the user from overlapping injections. One fuzzy controller adjusts the amount of insulin by producing a coefficient factor according to the age and body mass index of the patient, another one purposes insulin doses comparing the patient’s glucose readings. In this prototype, Centroid method, which is the most common method used in fuzzy logic systems, was used for defuzzyfication process. Unlike prior studies, our proposed system compares three arbitrary blood glucose readings and proposes an insulin dosage to regulate blood glucose level of the patient. The system was tested using blood glucose readings of a real type 1 diabetes patient. Additionally, a second type-1 diabetes mellitus patient was used to test the system stability and adaptive abilities. Moreover, generated insulin dosages were compared with the multiple daily injection treatment dosage to prove system’s reliability. Finally, MATLAB programming environment and fuzzy logic toolbox were used to design the system.Yüksek LisansM.Sc

The lived experience of continuous subcutaneous insulin infusion in adults with Type 1 Diabetes Mellitus: a phenomenological inquiry

Continuous subcutaneous insulin infusion (CSII) is a complex, medical device for the management of Type 1 Diabetes Mellitus (T1DM) that has gained popularity due to reported improvements in metabolic control and flexibility. Despite the growing number of CSII users, there is limited research exploring the everyday experiences living with this device. The purpose of my study was to understand the lived experience of adults using CSII therapy to manage T1DM. Accounts of lived experiences from eight individuals were collected through semi-structured interviews and then analysed using Max van Manen’s (1990) hermeneutic approach to phenomenology. Four substantive themes with supporting subthemes were identified including transitioning: not a quick fix; CSII: making an invisible illness visible; the internal struggle and impact on mental health; and, the impact on relationships and the meaning of support. Viewed together, these themes and subthemes represent the essence of participant experiences; that is, living with CSII eventually took ascendancy over managing T1DM. This research is one of few qualitative studies that explores the lived experience of CSII and has significant implications for healthcare professional practice, education, research, and policy and administration

Enjeux éthiques et psychosociaux soulevés par le pancréas artificiel

Le pancréas artificiel, une technologie médicale portative, est développé pour simplifier et améliorer la gestion et le contrôle du diabète de type 1. Il est constitué de deux dispositifs médicaux déjà commercialisés, soit la pompe à insuline et le lecteur de glycémie en continu. Un logiciel spécialisé, qui est la composante innovante de ce système, ajuste automatiquement les infusions d’insuline de la pompe à insuline aux lectures prises par le lecteur de glycémie en continu. Comme toute technologie médicale, le pancréas artificiel engendre des enjeux psychosociaux et éthiques qui influenceront son succès clinique auprès des personnes atteintes du diabète de type 1, mais ces enjeux n’ont pas été suffisamment approfondis. Ainsi, ce projet de recherche a pour objectif d’identifier et de caractériser les enjeux psychosociaux et éthiques soulevés par le pancréas artificiel. Pour y parvenir, nous avons effectué une analyse éthique de la littérature biomédicale sur le pancréas artificiel suivie d’une étude qualitative des perspectives de personnes atteintes du diabète de type 1 sur cette technologie. Les enjeux psychosociaux et éthiques identifiés par l’analyse éthique et l’étude qualitative se regroupent en cinq catégories : (1) le partage du contrôle du diabète de type 1 avec le pancréas artificiel, (2) l’image corporelle et la corporalité, (3) l’encadrement optimal et les attentes réalistes, (4) l’accès au pancréas artificiel et (5) la confidentialité, la sécurité et la sûreté. Puisque ces enjeux influenceront le succès du pancréas artificiel, ils sont pertinents pour les professionnels de la santé, les développeurs de la technologie et les décideurs publics.The artificial pancreas, a wearable medical technology, is being developed to simplify and improve type 1 diabetes management and control. It includes two medical devices that are already available on the market, notably the insulin pump and the continuous glucose monitor. Its innovative component is a software that automatically adjusts the insulin pump’s infusions to the continuous glucose monitor’s glycaemic readings. As with any other medical technology, the artificial pancreas likely raises psychosocial and ethical issues that could impact its clinical success among people with type 1 diabetes, but these issues have not been extensively studied. Consequently, the objective of this research project is to identify and characterize the psychosocial and ethical issues that could be raised by the artificial pancreas. To this end, we conducted an ethical analysis of the biomedical literature followed by a qualitative study of the perspectives of people with type 1 diabetes on this technology. The psychosocial and ethical issues identified through the ethical analysis and the qualitative study are grouped under five categories: (1) shared control of type 1 diabetes with the artificial pancreas, (2) body image and embodiment, (3) optimal support and realistic expectations, (4) access to the artificial pancreas, and (5) confidentiality, security, and safety. As these issues may influence the success of the artificial pancreas, they are relevant to healthcare professionals, technology developers, and policymakers

Studied in the context of medical device activities at the pharmaceutical company Novo Nordisk A/S in the period 1980-2008

Increased globalization in business competition makes the ability to innovate and to redefine strategy crucial to a company. An interesting question however is if a management team can control innovation and strategic renewal of the company at all; or do such changes emerge, driven by external events or by bottom-up processes in the organization? The present research project addresses some of these issues through the overall research question “How does innovation strategy evolve?” The research question is examined in a specific empirical context. Since 2001, I have worked as an internal innovation consultant at Novo Nordisk A/S; a pharmaceutical firm founded in 1923 operating in a well established industry (insulin for diabetes treatment), characterized by intensive investments in Research and Development. I took advantage of this unique access to the internal life of an organization and consequently set up my research project as a longitudinal in-depth case study of the medical device innovation activities at Novo Nordisk A/S covering the period 1980-2008. The study specifically analyzes the relationship between the classic core product of the firm (insulin) and complementary products (medical devices, such as insulin ‘pens’), which hold the potential to either enhance the value of the core product, or to become a distinct business of its own. Burgelman’s evolutionary theory of strategy making, especially his ‘internal ecology model’ (Burgelman 1991, 2002), has been chosen as the basic theoretical framework for the project. Some expansions of this framework, however, were needed. First, the present study puts greater emphasis on analyzing the external environment and its influence on internal strategy processes. Second, the analysis includes the role of management cognition, especially the notion of the corporate dominant logic (Prahalad & Bettis, 1986; Bettis & Prahalad, 1995), understood as an enduring top management worldview or mindset based on reinforcement of experiences from the past. With regard to results, the present study identifies a more entrepreneurial role of the top management driven induced strategy process than traditionally described in evolutionary theory. In this case study, strategic variation and trial-and-error learning is not restricted to the autonomous initiatives in the ‘internal ecology’; on the contrary, top management cognition creates strategic visions or hypotheses, which are enacted as experiments in the market, for example in the form of new product categories. External feedback determines the destiny of these strategic experiments. Thereby innovation strategy (in case, for medical devices) serves as a strategic laboratory at corporate level, so to speak. The device-based strategic experiments face the challenge of escaping the gravity of the dominant logic, which repeatedly pulls the strategy back towards the well-known success formula, centered on the drug itself (i.e. the insulin). Thus, the induced strategy process mediates core assets (pharmaceutical drugs) and complementary assets (medical devices), by swinging the pendulum between cycles of innovation strategy which define the devices as core or complementary respectively. Hence, the balance between what is defined as core and what is defined as complementary in the corporate innovation strategy seems to be dynamic and negotiable. As a consequence of the cycles of strategic experimentation, the corporate induced strategy process acts as a force of strategic entrepreneurship, seen over extended time. The implications for research point towards a new paradigm of strategic research in the ‘middle ground’ between rational choice theory and evolutionary theory, as proposed by Gavetti & Levinthal (2004). The present research project suggests that a firm’s ability for strategic adaptation depends both on strategic context determination of autonomous initiatives in the ‘internal ecology’ and on ability to enact induced strategic experiments with alternating innovation strategies in the market. This theory of ‘inbound’ and ‘outbound’ strategic search establishes a dynamic understanding of the corporate induced strategy process. In this understanding, innovation strategies act as hypotheses, which create strategic dissonance between vision and reality and thereby drive strategic learning. The implications for management practice are first recognition of how fortunate it has been for Novo Nordisk to sustain the core business strategy, protected by the dominant logic. This fact relates to a background where the core market proved to hold immense growth potential, and the industry was relatively stable compared to for instance the IT industry. On the other hand, Novo Nordisk’s success is partly due to cycles of strategic experiments with complementary assets for innovation, in case medical devices. Top management initiated these explorative experiments and the learning was utilized for expansion of the position within the core business. Hence, one can conclude that a company should explore and utilize the value of complementary assets, since these are perfect tools for strategic experimentation without risking the core business

A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial.

BACKGROUND: Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. DESIGN: Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. SETTING: Eight secondary care diabetes centres in the UK. PARTICIPANTS: Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. INTERVENTIONS: Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm(®) Veo(TM) (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). MAIN OUTCOME MEASURES: Primary outcome - change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome - proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months - moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. RESULTS: We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was -0.24% [95% confidence interval (CI) -0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of -0.36% (95% CI -0.64% to -0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. LIMITATION: Blinding of pump therapy was not possible, although an objective primary outcome was used. CONCLUSION: Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. RESEARCH PRIORITY: To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61215213. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 20. See the NIHR Journals Library website for further project information

Teachers supporting learners with diabetes: a psycho-educational perspective

The purpose of this study was to develop a set of guidelines to enable teachers to support children with diabetes. The aspects of support include the physical, emotional, social and cognitive aspects that have an effect on a child with diabetes. A literature study and an empirical investigation were undertaken to investigate which factors would enable teachers to become better sources of support in school. Semi-structured interviews were conducted with teachers to determine their knowledge about diabetes. Parents who have children with diabetes were also interviewed to determine what support they required from teachers. The results of the study culminated in a set of guidelines for teachers.Psychology of EducationM. Ed. (Specialisation in Guidance and Counselling

Habitudes de vie et contrôle glycémique chez des adultes atteints de diabète de type 1 : des barrières envers l’activité physique au calcul des glucides

Le diabète de type 1 (DT1) est une maladie complexe qui requiert une implication importante des patients pour contrôler leur glycémie et ainsi prévenir les complications et comorbidités. L’activité physique (AP) régulière et une attention constante pour les glucides ingérés sont des adjuvants essentiels au traitement insulinique. Nous avons démontré que le questionnaire BAPAD-1, spécifiquement développé pour des adultes atteints de DT1, est un outil valide (validité prédictive, fiabilité interne et reproductibilité) pour définir des barrières associées à l’AP. Bien que le niveau de barrières envers l’AP soit faible, la crainte de l’hypoglycémie est la barrière la plus importante chez cette population. L’adoption d’un mode de vie actif est associée à un profil corporel favorable. Les adultes, avec un DT1 et non diabétique, qui maintiennent un bon niveau d’AP, soit un ratio entre la dépense énergétique totale et celle au repos ≥ 1.7, ont une masse grasse, un indice de masse corporelle et un tour de taille significativement inférieurs à ceux d’adultes moins actifs. Le niveau d’AP peut être estimé au moyen d’un moniteur d’AP comme le SenseWear Armband™. Afin de compléter les études de validation de cet outil, nous avons évalué et démontré la reproductibilité des mesures. Toutefois, la dépense énergétique est sous-estimée durant les 10 premières minutes d’une AP d’intensité modérée sur ergocycle. L’utilisation de cet appareil est donc justifiée pour une évaluation de la dépense énergétique sur de longues périodes. Le calcul des glucides est une méthode largement utilisée pour évaluer la quantité d’insuline à injecter lors des repas. Nous avons évalué dans un contexte de vie courante, sans révision de la technique, la précision des patients pour ce calcul. L’erreur moyenne est de 15,4 ± 7,8 g par repas, soit 20,9 ± 9,7 % du contenu glucidique. L’erreur moyenne est positivement associée à de plus grandes fluctuations glycémiques mesurées via un lecteur de glucose en continu. Une révision régulière du calcul des glucides est probablement nécessaire pour permettre un meilleur contrôle glycémique. Nous avons développé et testé lors d’un essai clinique randomisé contrôlé un programme de promotion de l’AP (PEP-1). Ce programme de 12 semaines inclut une séance hebdomadaire en groupe ayant pour but d’initier l’AP, d’établir des objectifs et d’outiller les adultes atteints de DT1 quant à la gestion de la glycémie à l’AP. Bien que n’ayant pas permis d’augmenter la dépense énergétique, le programme a permis un maintien du niveau d’AP et une amélioration de la condition cardio-respiratoire et de la pression artérielle. À la fin du programme, une plus grande proportion de patients connaissait la pharmacocinétique de l’insuline et une plus grande variété de méthodes pour contrer l’hypoglycémie associée à l’AP était utilisée. En conclusion, le diabète de type 1 engendre des défis quotidiens particuliers. D’une part, le calcul des glucides est une tâche complexe et son imprécision est associée aux fluctuations glycémiques quotidiennes. D’autre part, l’adoption d’un mode de vie actif, qui est associée à un meilleur profil de composition corporelle, est limitée par la crainte des hypoglycémies. Le programme PEP-1 offre un support pour intégrer l’AP dans les habitudes de vie des adultes avec un DT1 et ainsi améliorer certains facteurs de risque cardio-vasculaire.Type 1 diabetes (T1D) is a complex disease requiring continuous self-management. Physical activity (PA) and carbohydrate counting are essential counterparts to insulin therapy for blood glucose control in order to prevent complications and comorbidities. We have demonstrated the validity (predictive validity, internal validity and reproducibility) of the BAPAD-1 scale to assess perceived barriers associated with PA practice. Fear of hypoglycemia is the strongest perceived barrier among adults with T1D. An active lifestyle, as described by a physical activity level (ratio of total over resting energy expenditure) ≥ 1.7, is associated with a better body composition compared to less active adults. Adults who are more active show significantly less fat mass, smaller body mass index and smaller waist circumference. Motion sensors, like the SenseWear Armband™, are useful to estimate PA level. To complement prior validation studies, we evaluated and confirmed the reproducibility of the SenseWear Armband™ measurements. However, we also observed that energy expenditure is underestimated at the onset of moderate intensity ergocycling. Thus, this motion sensor should be used to evaluate energy expenditure over long periods of time rather than short length exercise. Carbohydrate counting is a widely used method to evaluate prandial insulin doses. We evaluated, in a real-life setting without prior method revision, the accuracy of adults with T1D for carbohydrate estimation. The mean meal error was 15.4 ± 7.8 g or 20.9 ± 9.7 % of total carbohydrate content. The mean meal error was positively associated with larger daily glucose fluctuations measured by a continuous glucose monitoring system. Regular educational tips regarding carbohydrate counting may be necessary to improve glycemic control. In order to improve PA practice, we developed and tested in a randomized controlled trial a PA promotion program (PAP-1). This 12-week program includes a weekly group session designed for PA initiation, goal setting and improving knowledge about glycemic control during PA. Even if the program failed to improve total energy expenditure, participants improved their cardiorespiratory fitness and blood pressure. At the end of the program, a larger proportion of the participants were knowledgeable of insulin pharmacokinetics and they used more various methods to prevent hypoglycemia related to PA. In conclusion, type 1 diabetes obtrudes many daily challenges. On one hand, carbohydrate counting is a complex job and its inaccuracy is associated with glycemic fluctuations. On the other hand, even if having an active lifestyle is associated with a better body composition, fear of hypoglycaemia may impede PA practice. The PAP-1 program offers support to adults with T1D to adopt an active lifestyle and thus improve some cardivascular risk factors