Approximately 5 percent of the Swedish population is diagnosed with either type 1 or type 2 diabetes. A growing treatment method for type 1 patients is to supply the body with insulin using a pump. This thesis investigates if the use of pumps improves the health of the patients using two-way fixed effects regressions on quality register data on Swedish diabetes patients. I find statistically significant results indicating health benefits for type 1 diabetes patients, though smaller than previous studies. For future research, I suggest estimating quality of life changes from using an insulin pump in order for policymakers to make fully informed decisions on insulin treatment.

Type 1 diabetes (T1D) is characterised by an absolute insulin deficiency resulting from the chronic and progressive destruction of pancreatic β-cells by the immune system cells. Continuous subcutaneous insulin infusion (CSII) is becoming a popular technique for insulin delivery among T1D patients. Exercise is known to exert anti-inflammatory effects and metabolic control. Therefore it was of interest to study this in T1D using CSII. The objectives of this thesis were to further understanding of the effect of exercise on blood glucose, hemoglobin A1c, lipids, insulin and inflammatory markers in healthy and T1D volunteers. Three studies have been investigated where the diabetic volunteers used multi daily injections (MDI) or CSII. Firstly a survey was conducted aimed to investigate the effect of exercise on T1D patients using CSII therapy. The second study examined the acute and chronic effects of resistance and cardio exercise at moderate intensity on inflammatory markers such as IL-6, IL-1β, TNF-α and IFN-γ in healthy and T1D using MDI or CSII. Finally, a study was undertaken to find out the effects of chronic moderate intensity exercise on lipids profile and glycaemic control in healthy and T1D using MDI or CSII. The statistical analysis of the survey showed that CSII therapy for T1D had a significant reduction on A1c, insulin requirement and improvement of lipids profile compared to MDI. Moreover, majority of CSII users (63%) rarely suffered from hypoglycemia during exercise. The second study demonstrated that acute and chronic exercises have a positive impact on the inflammatory markers among CSII users e.g. in CSII users statistically significant increase in IL-6 and TNF-α levels were observed (P=0.014 and P=0.001 respectively). The last study showed that lipids profile, total daily insulin units were improved and A1c levels were significantly reduced in CSII as well as MDI groups after 6 weeks of exercise. T1D affects major organs e.g. heart, kidneys, blood vessels etc. However, good glycaemic control can reduce the risk of diabetes complications. This study suggested that CSII therapy along with exercise can maintain the BG level close to normal, as all 5 participants of the study showed an improvement in their BG levels after exercise.

Introduction: The management of type 1 diabetes through the use of Continuous Subcutaneous Insulin Infusion (CSII); also known as insulin pump therapy, has become an increasingly popular option for children and adolescents. A systematic review of studies that measured Quality of Life (QoL) in children associated with CSII was conducted. Eighteen studies were reviewed, and the results showed insufficient evidence to conclude that CSII improves QoL in children and adolescents with type 1 diabetes. The current study aimed to address the gap in the literature by exploring children and parents’ perspectives on the use of CSII for managing diabetes. Method: Data were gathered from five children aged 8 – 14 years (and five parents), using one to one semi-structured interviews. Interviews were recorded, transcribed and analysed using Interpretative Phenomenological Analysis (IPA). Results: Five super-ordinate themes were identified for parents: ‘Parenting a Child with Diabetes’; ‘Worth the Hard Work’; ‘Strive for Normality’; The Pump as an Enabler’; and ‘An eye on the Future’. Three Super-ordinate themes were identified for children ‘Feeling Different’; Grappling for Control’; and ‘Better…’ which were associated with a central theme of ‘Developing a Relationship with the Pump’. Children’s data is presented separately within a journal article format. Discussion: Findings suggest that parents value the insulin pump, despite acknowledging the challenges, particularly the hard work required to manage it. Children seemed to have an ambivalent but developing relationship with the insulin pump. They experience a number of benefits and drawbacks associated with the use of CSII and it seems to affect their identity and their locus of control. Conclusion: This research provides a greater insight into the lived experience of CSII for children and their parents. The benefits of CSII seemed to outweigh the challenges involved particularly for parents; and children seemed to be developing a relationship with the pump within the realms of their relationship with diabetes.

Diabetes affects an estimated 29.1 million Americans, with approximately another 1/3 of Americans not yet diagnosed. Complications associated with diabetes include heart disease, stroke, hypertension, blindness, kidney disease, neuropathy and death. All of these complications can be prevented with optimal control of blood glucose levels. Advances in technology provide people living with diabetes (PLWD) a multitude of treatment options such as continuous subcutaneous insulin infusion (CSII) therapy. Unfortunately, sustained improvement in glycated hemoglobin A1c (HgA1c) is not always achieved even with this advanced therapy. The purpose of this doctoral project was to educate nurses on CSII therapy and promote improved patient compliance, knowledge and ultimately improve HgA1c control. This doctoral project is an evaluation of an Evidence-Based Quality Improvement Project (EB-QIP) that evaluated nurse-led educational sessions for PLWD using CSII therapy. The integrated theory of health behavior change was used to guide the project. The CDC process evaluation model was used to evaluate the outcomes of the education sessions. Results showed that patients who were instructed by the nurses who took part in the EB-QIP had a reduction in the overall HgA1c by an average of 1.1 points 3-months post-education. The project promotes positive social change through establishing the effectiveness of an EB-QIP that focused on the use of education on CSII therapy in improving outcomes for patients living with diabetes.

Insulin pumps are designed for the self-management of diabetes mellitus in patients and are known for their complexity of use. Pump manufacturers engage trainers to teach patients how to use the devices correctly to control the symptoms of their disease. Usability research related to insulin pumps and other infusion pumps with first-time users as participants has centered on the relationship between user interface design and the effectiveness of task completion. According to prior research, the characteristics of system behavior in a real life environment remain elusive. A suitable approach to acquire information about potential usability problems encountered by first-time users is to obtain this information from the health care professionals who train them. The purpose of the study was to discover the lived experiences and shared impressions of insulin pump trainers during training sessions with first-time users. Interpretative Phenomenological Analysis (IPA) was used to uncover the phenomena associated with usability challenges that first-time users of insulin pumps face when learning to use the device. Six participants representing a homogeneous sample were recruited from a wide geographic area in the United States, and semi-structured interviews containing open-ended questions were conducted with the respondents. The data from the lived experiences and shared impressions of the participants were used to develop the following five super-ordinate themes: Emotion-charged Environment, Personalized Training, Safety Issues and Disaster Planning, Professional Dedication, and The Voice. The essence of participants’ experience was described around the pivotal moment when the training sessions are successfully completed and insulin pump therapy becomes alive. The findings of this study have implications for information systems professionals who conduct research on the safe design and usability of safety critical medical devices. In addition, the findings from this study create opportunities for practice to improve the initiation of insulin pump therapy in patients with diabetes.

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Type 1 diabetes is one of the most common chronic conditions in childhood and adolescence. Despite ongoing development of more physiological insulin preparations, recent advancements in insulin pump technology and more accurate blood glucose monitoring, in clinical practice it remains challenging to achieve normoglycaemia whilst reducing the risk of hypoglycaemia, particularly in young people with type 1 diabetes. Closed-loop insulin delivery (the artificial pancreas) is an emerging technology gradually progressing from bench to clinical practice. Closed-loop systems combine glucose sensing with computer-based algorithm informed insulin delivery to provide real-time glucose-responsive insulin administration. The key objective of my thesis is to evaluate the safety, efficacy and utility of closed-loop insulin delivery in children and adolescents with type 1 diabetes outside of the research facility setting. Results of five clinical trials are presented in the main chapters of this thesis. In a mechanistic study, the impact of glucose sensor operation duration on efficacy of overnight closed-loop was investigated comparing closed-loop performance on day 1 of sensor insertion to day 3 to 4 of sensor. Twelve adolescents with type 1 diabetes attended the research facility for two overnight visits. The sequence of the interventions was random. Despite differences in sensor accuracy, overnight CL glucose control informed by sensor glucose on day 1 or day 3-4 after sensor insertion was comparable. The model predictive controller appears to mitigate against sensor inaccuracies. In home settings, overnight closed-loop application was evaluated over three months in 25 children and adolescents with type 1 diabetes aged six to 18 years. The study was conducted at three centres in the UK and adopted a randomised cross-over design. Compared to sensor-augmented pump therapy, overnight home use of closed-loop increased the proportion of time sensor glucose was in target, and reduced mean glucose and hypoglycaemia. Two randomised crossover studies evaluated the safety and efficacy of day-and-night hybrid closed-loop insulin delivery in young people with type 1 diabetes aged 10 to 18 years over seven days, and 21 days, respectively. A total of 24 subjects were enrolled in this single centre trial. Free-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes was safe, and improved glucose control without increasing the risk of hypoglycaemia. Finally, closed-loop technology was assessed in five very young children (aged one to seven years) with type 1 diabetes in a two-period, crossover study. Closed-loop was used during both 3-week intervention periods, either with standard strength insulin (U100), or with diluted insulin (U20). The order of intervention was random. Free-living home use of day-and-night hybrid closed-loop in very young children with type 1 diabetes was feasible and safe. Glucose control was comparable during both intervention periods. Thus, use of diluted insulin during closed-loop insulin delivery might not be of additional benefit in this population. In conclusion, studies conducted as part of my thesis demonstrate that use of hybrid closed-loop insulin delivery systems in children and adolescents aged one to 18 years in free daily living without remote monitoring or supervision is feasible, safe and effective. My work supports the progression of this technology from research to mainstream clinical practice.

abstract: Type 1 diabetes (T1D) is a chronic disease that affects 1.25 million people in the United States. There is no known cure and patients must self-manage the disease to avoid complications resulting from blood glucose (BG) excursions. Patients are more likely to adhere to treatments when they incorporate lifestyle preferences. Current technologies that assist patients fail to consider two factors that are known to affect BG: exercise and alcohol. The hypothesis is postprandial blood glucose levels of adult patients with T1D can be improved by providing insulin bolus or carbohydrate recommendations that account for meal and alcohol carbohydrates, glycemic excursion, and planned exercise. I propose an evidence-based decision support tool, iDECIDE, to make recommendations to improve glucose control by taking into account meal and alcohol carbohydrates, glycemic excursion and planned exercise. iDECIDE is deployed as a low-cost and easy to disseminate smartphone application. A literature review was conducted on T1D and the state-of-the-art in diabetes technology. To better understand self-management behaviors and guide the development of iDECIDE, several data sources were collected and analyzed: surveys, insulin pump paired with glucose monitoring, and self-tracking of exercise and alcohol. The analysis showed variability in compensation techniques for exercise and alcohol and that patients made unaided decisions, suggesting a need for better decision support. The iDECIDE algorithm can make insulin and carbohydrate recommendations. Since there were no existing in-silico methods for assessing bolus calculators, like iDECIDE, I proposed a novel methodology to retrospectively compare insulin pump bolus calculators. Application of the methodology shows that iDECIDE outperformed the Medtronic insulin pump bolus calculator and could have improved glucose control. This work makes contributions to diabetes technology researchers, clinicians and patients. The iDECIDE app provides patients easy access to a decision support tool that can improve glucose control. The study of behaviors from diabetes technology and self-report patient data can inform clinicians and the design of future technologies and bedside tools that integrate patient’s behaviors and perceptions. The comparison methodology provides a means for clinical informatics researchers to identify and retrospectively test promising insulin blousing algorithms using real-life data. / Dissertation/Thesis / Doctoral Dissertation Biomedical Informatics 2017

Bakgrund: Med bättre behandlingar och en förlängd livslängd i samhället ökar antalet äldre personer med typ 1 diabetes. En god metabol kontroll och undvikande av låga och höga glukosvärden kan resultera i minskad risk för fall, malnutrition, nedsatt kognition och även diabeteskomplikationer hos äldre, vilka alla är kostsamma för såväl individen som för samhället. Avancerade hjälpmedel som insulinpumpar med integrerad kontinuerlig glukosmätning kan underlätta för äldre som lever med typ 1 diabetes och leder till förbättrad metabol kontroll. Syfte: Att beskriva upplevelsen av att leva med avancerad insulinpump och tillhandahållet stöd för äldre personer med typ 1 diabetes. Metod: Denna uppsats har utförts med kvalitativ, induktiv ansats och med semistrukturerade intervjuer med tio deltagare. Resultatet har förankrats teoretiskt med personcentrerad vård. Resultat: Deltagarna hade övervägande positiva upplevelser av behandlingen med avancerad insulinpump. De såg systemet som god hjälp och ett användbart verktyg för att bibehålla en god glukoskontroll och för att minska bördan av diabetes. De hade en lång erfarenhet av att leva med diabetes och insulinpump och upplevde relativt få praktiska svårigheter. Det kunde vara utmaningar att införliva ny kunskap och att släppa på kontrollen, samtidigt som deras erfarenheter till stor del underlättade hanteringen av insulinpumpen. Många var nöjda med det stöd de fick från vårdpersonal och ansvarigt företag, men efterlyste tätare uppföljning och enklare teknisk support. Slutsats: Äldre personer med typ 1 diabetes upplever behandlingen med avancerad insulinpump som oumbärlig. De har god hjälp av sin tidigare erfarenhet, de löser behandlingen på ett ändamålsenligt sätt och kan bibehålla en god metabol kontroll. Det är av stor vikt att diabetessjuksköterskan har kunskap om diabetesteknik och genom personcentrerad vård möjliggör för äldre personer med typ 1 diabetes att fortsätta använda avancerad insulinpump. / Background: With better treatments and an extended lifespan in society, the number of elderly people with type 1 diabetes is increasing. Good metabolic control and avoidance of low and high glucose levels can result in a reduced risk of falls, malnutrition, impaired cognition and diabetes complications in the elderly, all of which are costly for both the individual and society. Advanced devices such as insulin pumps with integrated continuous glucose monitoring can help seniors living with type 1 diabetes and has led to improved metabolic control. Purpose: To describe the experience of living with an advanced insulin pump and the provided support for older people with type 1 diabetes. Method: The present academic essay was conducted with a qualitative, inductive approach and with semi-structured interviews with ten participants. The result has been grounded theoretically with person-centered care. Results: The participants had predominantly positive experiences of the advanced insulin pump treatment. They saw the device as good help and a useful tool to maintain adequate glucose control and to reduce the burden of diabetes. They had a lifelong experience of living with diabetes and an insulin pump and experienced relatively few practical difficulties. Incorporating new knowledge and to let go of control could be challenging, while their experiences greatly facilitated the management of the insulin pump. Many were satisfied with the support they received from healthcare professionals and the supporting company but called for closer follow-up and easier technical support. Conclusion: Older people with type 1 diabetes find treatment with an advanced insulin pump to be indispensable. They have good help from their previous experience, they solve the treatment in an effective way and can maintain an adequate metabolic control. It is of great importance that the diabetes nurse has knowledge of diabetes technique and through person-centered care make it possible for older people with type 1 diabetes to continue using advanced insulin pumps.