Diabetes Technology & TherapeuticsVol. 17, No. S1 Original ArticlesFree AccessDiabetes Technology and the Human FactorAlon Liberman, Moshe Phillip, and Bruce BuckinghamAlon LibermanJesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.Search for more papers by this author, Moshe PhillipJesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.Search for more papers by this author, and Bruce BuckinghamStanford Medical Center, Division of Endocrinology and Diabetes, Stanford, CA.Search for more papers by this authorPublished Online:13 Feb 2015https://doi.org/10.1089/dia.2015.1513AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail IntroductionType 1 diabetes (T1D) is a common chronic childhood disease, and its prevalence is among the highest worldwide. This chronic condition significantly impacts quality of life of children, adolescents, and their parents. In order to maintain optimal glycemic control and to reduce the risk of severe diabetic complications, a very strict and demanding treatment regimen is required.The significant development achieved in the past few decades in diabetes technologies has made diabetes technological devices such as continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) an important component of diabetes treatment. Many studies conducted in recent years have emphasized the advantages of using these technologies to improve diabetes control, but the role of patients' understanding and continued use of these technologies remains central to these technologies being beneficial.The scientific field of “human factors” utilizes information from a variety of disciplines, including psychology, engineering, industrial design, statistics, biomechanics, ethnography, and physiology, and focuses on people and their interaction with products and technology in both home and work environments (1).In the medical field, it tests actual medical device use by representative users to identify risks for when humans interface with the device. This differs from market research that collects data on opinions and attitudes about the possibility of purchasing the device. The FDA has been increasingly asking for human factor studies before a device is placed on the market in users' hands (2). A sentinel event demonstrating the importance of human factors analysis was the release of a bedside infusion pump in which the “on/off” switch was located too close to the “start” key, and nurses were turning the pump off when they intended to start infusions (3). From this point of view, one can think of several aspects of human factors that might affect the patients' use and adherence to diabetes technology, for example, the technological aspect (e.g., if the pump's screen touch is “user friendly”), the physical contact of devices with the subject (e.g., ease of insertion, ease of wear, tape issues with sensors, and infusion sets), the perceived accuracy of the devices, the effect of knowledge gained from the devices on human interactions (ability of parents to monitor their children and adolescents), and whether these devices increase or decrease the perceived burden of taking care of diabetes. As an example, current CGM devices are not labeled to replace meter glucose readings when making management decisions such as giving insulin or treating hypoglycemia; however, if the user perceives that sensors are accurate, they could begin making insulin dose decisions based on the sensor and not meter readings. In the present article, some of the studies that have been published from July 2013 to June 2014 that involve human factors will be reviewed and discussed.Human factors research applied: the development of a personal touch screen insulin pump and users' perceptions of actual useSchaeffer NETandem Diabetes Care Inc., San Diego, CADiabetes Technol Ther 2013;15: 845–54AimsA short review of the field of human factors research is covered, along with how this field is leveraged within medical device companies to prevent design flaws in products in order to make them safe and effective for human use. The way in which human factors research was used to develop the t:slim® insulin delivery system (Tandem Diabetes Care® Inc., San Diego, CA) is also discussed. Following the development of the t:slim pump, a product evaluation study was conducted to assess users' perceptions of the t:slim pump under actual-use conditions versus their current pump system.Subjects and MethodsThis was a study of 74 subjects who used the t:slim insulin pump in their normal environment for 30 days. Participants were given the Insulin Delivery System Rating Questionnaire during their first visit to evaluate their current insulin pump and then at the end of the research to measure their views of the t:slim pump. A paired-samples t-test was completed to analyze the data.ResultsThe results indicated that 16 of the questionnaire variables showed statistically significant differences in scores (total number of questions is 70).ConclusionsThe authors found that the utilization of a systematic human factors process resulted in an insulin pump that was proved to be safe and effective for participants' use and was cleared by the Food and Drug Administration for use in the United States. In addition, the results of the product assessment research showed that, after use of the t:slim pump for 30 days, participants' perceptions of several variables improved.CommentThis article provides a quick overview of human factors analysis and gives an example of how human factor research was applied to the development of an insulin pump with a touch screen. They used a strategy called “prevention through design” (4), emphasizing the inclusion of representative users through the testing of actual touch screens to complete the typical tasks of a pump user (entering a BG and/or carbs; delivering a bolus; editing and reviewing a personal profile; responding to alarms and reminders; and loading a reservoir). The human factors studies were conducted simultaneously with the product design and were able to influence product design. This was an integrated process that allows design flaws to be uncovered through iterative usability testing.Accuracy and acceptability of the 6-day Enlite continuous subcutaneous glucose sensorBailey TS1, Ahmann A2, Brazg R3, Christiansen M4, Garg S5, Watkins E6, Welsh JB7, Lee S71AMCR Institute, Escondido, CA; 2Oregon Health and Sciences University, Portland, OR; 3Rainier Clinical Research Center, Renton, WA; 4Diablo Clinical Research, Walnut Creek, CA; 5Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, CO; 6Profil Institute for Clinical Research, Chula Vista, CA; and 7Medtronic MiniMed, Northridge, CADiabetes Technol Ther 2014;16: 277–83AimsThe authors of this study made an evaluation of the performance and acceptability of the Enlite® glucose sensor (Medtronic MiniMed, Inc., Northridge, CA).Participants and MethodsNinety adults with type 1 or type 2 diabetes wore two Enlite sensors on the abdomen and/or buttock for 6 days and calibrated them at different frequencies. On days 1, 3, and 6, accuracy was evaluated by comparison of sensor glucose values with frequently sampled plasma glucose values collected over a 12-h period. Accuracy was assessed at different reference glucose concentrations and during times when absolute glucose concentration rates of change were <1, 1–2, and >2 mg/dL/min. The sensor's ability to detect hypoglycemia or hyperglycemia was evaluated with simulated alerts. Subject satisfaction was evaluated with a 7-point Likert-type questionnaire, with a score of 7 indicating strong agreement.ResultsWith abdomen sensors under actual-use calibration (mean, 2.8±0.9 times/day), the overall mean (median) absolute relative difference (ARD) between sensor and reference values was 13.6% (10.1%); the corresponding buttock sensor ARD value was 15.5% (10.5%). With abdomen sensors under minimal calibration (mean, 1.2±0.9 times/day), the mean (median) ARD value was 14.7% (10.8%). Mean ARD values of abdomen sensors at rates of change of <1, 1–2, and >2 mg/dL/min were 13.6%, 12.9%, and 16.3%, respectively. With abdomen sensors, 79.5% and 94.1% of hypoglycemic and hyperglycemic events, respectively, were correctly detected; 81.9% and 94.9% of hypoglycemic and hyperglycemic alerts, respectively, were confirmed. The failure rates for abdomen and buttock sensors were 19.7% and 13.9%, respectively. Mean responses to survey questions for all subjects related to comfort and ease of use were favorable.ConclusionsThe Enlite sensor provided accurate data at different glucose concentrations and rates of change. Subjects found the sensor comfortable and easy to use.CommentThis study includes the subjective experience (i.e., acceptability) of patients' use of the 6-day Enlite continuous subcutaneous glucose sensor. In surveys not validated or tested for reproducibility, the sensor was described as easy to insert, comfortable to wear, and easy to use. Some patients had difficulty with unassisted buttocks insertions. It would be helpful if the authors had also used a validated CGM satisfaction questionnaire (5). In a previous study, convenience was the only significant determinant of satisfaction in using a sensor in pediatrics, whereas adults perceived clinical efficacy as also important (6). When initiating a new device for a patient, the diabetes team should address potential limitations of the technology and potential user interface issues (taping issues, insertion issues, wearability of the device, expected accuracy, reliability, and the potential for information overload and frequent alarms) as well as the positive aspects of the device. Realistic expectations will often result in higher acceptance and prolonged use of a device. It is important to remember that what engineers and physicians consider easy to use and successful may not be perceived by patients as easy to use and beneficial, and this will vary with the age group of the patient (7). The information drawn from patients' subjective experience can help the diabetes team to understand the way the patient perceives the device and help prevent diabetes technology dropouts.Real-time continuous glucose monitoring or continuous subcutaneous insulin infusion, what goes first?: results of a pilot studyMoreno-Fernandez J1, Gomez FJ2, Gazquez M1, Pedroche m2, García-Manzanares A2, Tenias Jm3, Benito P4, Gomez IR21Service of Endocrinology, Ciudad Real University Hospital, Ciudad Real, Spain; 2Service of Endocrinology, La Mancha-Centro Hospital, Ciudad Real, Spain; 3Research Support Unit, La Mancha-Centro Hospital, Ciudad Real, Spain; and 4Service of Endocrinology, Reina Sofia University Hospital, Cordoba, SpainDiabetes Technol Ther 2013;15: 596–600AimsDual devices allow both insulin pumps (CSII) and real-time (RT) continuous glucose monitoring (CGM). Patients often start with CSII, adding RT-CGM later (CGM post-CSII). Insufficient use of RT-CGM is the main cause for patients failing to use dual devices. Initiating RT-CGM ahead of CSII (CGM pre-CSII) could increase RT-CGM use and lead to better glycemic control.Subjects and MethodsIn this 26-week pilot study, the authors randomly assigned 16 subjects over 14 years of age with type 1 diabetes to either CSII prior to RT-CGM or RT-CGM prior to CSII. The Paradigm® Veo™ (Medtronic Inc., Northridge, CA) was the dual device used in all patients. The primary goal was frequency of use of RT-CGM between both groups at week 26.ResultsThe authors found significantly higher RT-CGM use in the CGM pre-CSII group compared to the CSII pre-CGM group at week 26 (78.4±10.9% vs. 56.0±40.8%; p=0.01). In addition, CGM pre-CSII patients presented less time in hypoglycemia (average daily area under curve <70 mg/dL per 24 h, 0.87±1.02 mg/dL/day vs. 3.32±2.19 mg/dL/day; p=0.021), and no severe hypoglycemia events were found during 26 weeks in this group. At the end of the study, the CGM pre-CSII had an A1c of 7.3±0.5 and the CGM post-CSII had an A1c of 6.6±0.8, but this was not statistically significant.ConclusionsCGM pre-CSII was found efficient in increasing RT-CGM frequency use in T1DM patients. This is in addition to a significant reduction in time in hypoglycemia.CommentMany studies showed consistently a significant improvement in diabetes control following use of RT-CGM. However, many patients report difficulties when using the sensor, which in turn leads to a significant reduction in adherence and even to sensor discontinuation (8). This pilot study suggested that gaining experience with CGM use for 3 weeks prior to beginning CSII therapy improved long-term (26-week) frequency of CGM use, although this effect was not seen at 12 weeks. This suggests that in order to improve adherence and use of CGM, patients should have adapted first to using CGM before connecting to CSII. This conclusion suggests that the adjustment time to the benefits and hassles of using CGM may be a latent factor influencing acceptance of this therapy.Alterations in white matter structure in young children with type 1 diabetesBarnea-Goraly N1, Raman M1, Mazaika P1, Marzelli M1, Hershey T2, Weinzimer SA3, Aye T4, Buckingham B4, Mauras N5, White NH6, Fox LA5, Tansey M7, Beck RW8, Ruedy KJ8, Kollman C8, Cheng P8, Reiss AL1,4,9; Diabetes Research in Children Network (DirecNet)1Department of Psychiatry and Behavioral Sciences, Center for Interdisciplinary Brain Sciences Research, Stanford, CA; 2Departments of Psychiatry, Neurology, and Radiology, Washington University in St. Louis, St. Louis, MO; 3Pediatric Endocrinology, Yale University, New Haven, CT; 4Department of Pediatrics, Stanford University, Stanford, CA; 5Pediatric Endocrinology, Nemours Children's Clinic, Jacksonville, FL; 6Departments of Pediatrics and Medicine, Washington University in St. Louis, St. Louis, MO; 7Pediatric Endocrinology, University of Iowa, Iowa City, IA; 8Jaeb Center for Health Research, Tampa, FL; and 9Department of Radiology, Stanford University, Stanford, CADiabetes Care 2014;37: 332–40This manuscript is also discussed in article on Diabetes Technology and Therapy in the Pediatric Age Group, p. S-97.AimsTo study if type 1 diabetes influences white matter (WM) structure in a large cohort of young children.Research Design and MethodsChildren aged 4 to 10 years diagnosed with type 1 diabetes (n=127) and age-matched nondiabetic control participants (n=67) had diffusion weighted magnetic resonance imaging scans in this multisite neuroimaging research. Subjects with type 1 diabetes were assessed for HbA1c history and lifetime adverse events, and glucose levels were monitored using a continuous glucose monitor (CGM) device and standardized measures of cognition.ResultsBetween-group analysis demonstrated that children with type 1 diabetes had significantly reduced axial diffusivity (AD) in widespread brain regions matching with control subjects. Within the type 1 diabetes group, earlier onset of diabetes was evaluated with increased radial diffusivity (RD) and longer duration was correlated with reduced AD, reduced RD, and increased fractional anisotropy (FA). In addition, HbA1c values were significantly negatively correlated with FA values and were positively correlated with RD values in widespread brain regions. Significant correlations of AD, RD, and FA were found for CGM measures of hyperglycemia and glucose variability but not for hypoglycemia. Lastly, the authors of this study observed a significant correlation between WM structure and cognitive ability in children with type 1 diabetes but not in control subjects.ConclusionsThe results of this study propose vulnerability of the developing brain in young children to effects of type 1 diabetes correlated with chronic hyperglycemia and glucose variability.CommentThe psychological concept of “cognition” (e.g., intellectual ability, visuospatial abilities, attention, memory, processing speed, and executive function) is based mostly on results drawn from assessments and evaluations based on observations, subjects' self-reports (i.e., questionnaires), and psychometric evaluations (i.e., Wechsler intelligence tests). The use of an MRI with diffusion tensor imaging (DTI) allows for a better understanding of possible white matter damage that could lead to cognitive changes in young children with type 1 diabetes. Previous studies suggest that the age of onset of type 1 diabetes (especially in children younger than 4) contributes to the presence of cognitive dysfunction (9). In addition, a snapshot of glycemic control was obtained with 6 days of CGM data within weeks of the MRI scan and cognitive testing. Measures of hyperglycemia and glucose variability were significantly associated with white matter structural changes, although measures of hypoglycemia were not. This suggests that not only hypoglycemia but also hyperglycemia needs to be controlled in young children and may support trying to achieve lower target A1c levels in this age group. A significant association between WM structure and cognitive ability in type 1 children in this age group was observed.Real-time continuous glucose monitoring significantly reduces severe hypoglycemia in hypoglycemia-unaware patients with type 1 diabetesChoudhary P1,2, Ramasamy S3, Green L2, Gallen G2, Pender S3, Brackenridge A3, Amiel SA1,2, Pickup JC1,31Division of Diabetes and Nutritional Sciences, King's College London, London, UK; 2Department of Diabetes, King's College Hospital, London, UK; and 3Department of Diabetes, Guy's and St. Thomas' NHS Foundation Trust, London, UKDiabetes Care 2013;36: 4160–62This manuscript is also discussed in article on Continuous Glucose Monitoring in 2014, p. S-14 and article on Insulin Pumps, p. S-22.AimsTo assess the effect of continuous glucose monitoring (CGM) on the frequency of severe hypoglycemia (SH) in participants with established hypoglycemia unawareness.Research Design and MethodsRetrospective examination of 35 participants with type 1 diabetes and problematic hypoglycemia unawareness, despite optimized medical therapy (continuous subcutaneous insulin infusion/multiple daily insulin injections), who used CGM for >1 year.ResultsOver a 1-year follow-up period, the median rates of SH were diminished from 4.0 (interquartile range [IQR] 0.75–7.25) episodes/patient-year to 0.0 (0.0–1.25) episodes/patient-year (p<0.001), and the mean (±SD) rates were reduced from 8.1±13 to 0.6±1.2 episodes/year (p=0.005). HbA1c was diminished from 8.1±1.2% to 7.6±1.0% over the year (p=0.005). The mean Gold score, measured in 19 participants, remained the same: 5.1±1.5 vs. 5.2±1.9 (p=0.67).ConclusionsIn a specialist experienced insulin pump center, in carefully selected participants, CGM diminished SH while improving HbA1c but was unable to restore hypoglycemia awareness.Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2×2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS)Little SA1, Leelarathna L2, Walkinshaw E3, Tan HK4, Chapple O5, Lubina-Solomon A3, Chadwick TJ6, Barendse S7, Stocken DD6, Brennand C6, Marshall SM1, Wood R6, Speight J7–9, Kerr D10, Flanagan D4, Heller SR3, Evans ML2, Shaw JA11Institute of Cellular Medicine, Newcastle University, Newcastle, UK; 2Wellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, UK; 3School of Medicine and Biomedical Sciences, Sheffield University, UK; 4Peninsula College of Medicine and Dentistry, Plymouth, UK; 5Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, UK; 6Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, Newcastle, UK; 7AHP Research, Hornchurch, UK; 8The Australian Centre for Behavioural Research in Diabetes, Diabetes Australia–Vic, Melbourne, Australia; 9Centre for Mental Health and Wellbeing Research, School of Psychology, Deakin University, Burwood, Australia; and 10Centre for Postgraduate Medical Research and Education, Bournemouth University, UKDiabetes Care 2014;37: 2114–22AimsThe objective of this study was to decide whether impaired awareness of hypoglycemia (IAH) can be improved and severe hypoglycemia (SH) prevented in type 1 diabetes. The authors compared an insulin pump (continuous subcutaneous insulin infusion [CSII]) with multiple daily injections (MDIs) and adjuvant real-time continuous glucose monitoring (RT) with conventional self-monitoring of blood glucose (SMBG).Research Design and MethodsA 24-week 2×2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted. All the subjects accepted matching education, support, and congruent therapeutic goals aimed at rigorous avoidance of biochemical hypoglycemia without relaxing overall control. Main end point was between-intervention difference in 24-week hypoglycemia awareness (Gold score).ResultsA total of 96 participants (mean diabetes duration 29 years) were randomized. Overall, biochemical hypoglycemia (≤3.0 mmol/L) decreased (53±63 to 24±56 min/24 h; P=0.004 [t test]) without decline in HbA1c. Hypoglycemia awareness had better results (5.1±1.1 to 4.1±1.6; P=0.0001 [t test]) with decreased SH (8.9±13.4 to 0.8±1.8 episodes/patient-year; P=0.0001 [t test]). At 24 weeks, there was no significant difference in awareness matching CSII with MDI (4.1±1.6 vs. 4.2±1.7; difference 0.1; 95% CI −0.6 to 0.8) and RT with SMBG (4.3±1.6 vs. 4.0±1.7; difference −0.3; 95% CI −1.0 to 0.4). Between-groups analyses demonstrated comparable reductions in SH, fear of hypoglycemia, and insulin doses with equivalent HbA1c. Treatment satisfaction was higher with Insulin Pump Therapy than MDI (32±3 vs. 29±6; P=0.0003 [t test]), but comparable with SMBG and RT (30±5 vs. 30±5; P=0.79 [t test]).ConclusionsHypoglycemia awareness can be improved and repeated SH prevented in long-standing type 1 diabetes without relaxing HbA1c. Similar biomedical results can be achieved with conventional MDI and SMBG regimens compared with CSII/RT, although satisfaction was higher with CSII.CommentSevere hypoglycemia events and hypoglycemia unawareness can be dangerous and damage quality of life. Diabetes technology (both CSII as well as CGM) have previously been reported to reduce severe hypoglycemic events and restore hypoglycemic awareness (10–12). Structured psychoeducational interventions such as Blood Glucose Awareness Training (BGAT) (13), a protocol that trains individuals with type 1 diabetes to detect and interpret internal cues to better detect extreme blood glucose levels, and to interpret external cues to detect current and anticipate future extreme blood glucose levels, can significantly reduce severe hypoglycemia and restore awareness in almost half of the patients who report hypoglycemia unawareness. In the present study, a similar education program given to all the participants at the onset of the study appeared to have the most significant effect in restoring hypoglycemia awareness and decreasing severe hypoglycemic events; however, other interventions such as introducing a weekly overnight meter blood glucose reading at 4:00 AM may also have had a significant impact. It was of interest that neither CSII nor real-time CGM had a significant impact on restoring hypoglycemia awareness or in decreasing the incidence of severe hypoglycemic events.Optimizing insulin pump therapy: a quality improvement projectMeade LT1,2, Rushton WE11Department of Endocrinology, Piedmont HealthCare, Statesville, NC; and 2School of Pharmacy, Wingate University, Wingate, NCDiabetes Educ 2013;39: 841–47AimsThe aim of the research was to evaluate insulin pump use and provide ongoing education.MethodsA quality improvement project using a pump evaluation questionnaire was implemented at an endocrinology office in the southeastern United States. The questionnaire was designed to assess all aspects of insulin pump therapy, including pump operations, infusion set failure, management of acute complications, and usage of advanced device features. Eighty-nine participants (80% with type 1 diabetes and 20% with type 2 diabetes) filled the questionnaire at the endocrinology practice. A certified diabetes educator reviewed the questions with each participant, identifying deficiencies and training opportunities.ResultsThe most frequent areas of deficiency identified from the questionnaire included the following domains: expired or no basal insulin prescription in the event of pump failure or removal, no mupirocin (Bactroban®; GlaxoSmithKline, Research Triangle Park, North Carolina) prescription for suspected site infections, lack of insulin syringe if pump stopped working, failure to check urine ketones, no antiemetic prescription for sick day intervention, using manual bolus instead of bolus calculator, and lack of in-date glucagon kit.ConclusionsUse of a pump evaluation form enables a focused discussion concerning patient behaviors related to pump operations, troubleshooting, and self-management. Incorporating use of a pump evaluation questionnaire into routine practice may result in improved patient education and avoidance of adverse events specific to CSII therapy.CommentThe issue of adherence to a diabetes regimen has great importance in achieving good glycemic control. Although patients' motivation is one of the central aspects of adherence to medical treatment, there are additional factors when considering the interaction between diabetes technology, human factors, and adherence. The questionnaire developed by the authors addresses this issue and suggests some interesting areas for optimizing the advantages of CSII use. Some common deficiencies described by participants were a lack of preparedness in special situations (e.g., expired or no basal insulin prescription in the event of pump removal or failure) and insufficient knowledge about pump features that prevented them from using the CSII to its full potential (e.g., using manual boluses instead of the bolus calculator). This study allows the diabetes team to identify the specific components of adherence and to develop a tailored education program for each patient.Family perceptions of insulin pump adverse events in children and adolescentsWheeler BJ1,2, Donaghue KC1,3, Heels K1, Ambler GR1,31The Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Sydney, Australia; 2Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand; and 3Discipline of Paediatrics and Child Health, the University of Sydney, Sydney, AustraliaDiabetes Technol Ther 2014;16: 204–7AimsInsulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable research of outcomes, there are few recent data on CSII-correlated negative events and no data on family perceptions of adverse events and their confidence in dealing with them.Subjects and MethodsThe authors approached all families of children and adolescents ≤19 years of age on CSII attending the diabetes clinic over a 16-week period. Subjects completed a retrospective questionnaire testing issues over the previous 12 months. Data on pump negative events as well as answers to questions pertaining to education and confidence were gathered.ResultsIn this study, a 99% response rate was received, with 235 of the 238 families approached participating. In the previous 12 months, 104 of 230 (45%) had reported at least one pump-related negative event (either mechanical or set-related), with 52 of 229 (23%) resulting in pump replacement. This equated to a minimum incidence density of 53 adverse events/100 person-years. Additionally, 18 of 230 (8%) reported a hospital admission or emergency department attendance as a consequence. Pump malfunction (58 of 104 [56%]) and infusion set/site failures (47 of 104 [45%]) were the most frequent events reported. Adverse events, excluding set/site failures, were correlated with older age (13.1±3.4 years vs. 11.9±4 years; p=0.02.ConclusionsThis is the first study to examine family perceptions of adverse events while using modern CSII. It highlights a high self-reported rate of CSII-related adverse events, pump replacement, and subsequent presentation to the hospital. Potential domains for additional targeted education are identified. A prospective study examining the incidence and characteristics of pump adverse events is warranted.CommentThis research continues the trend to not only take into consideration the patients' (and their parents' in the case of children and adolescents) personal satisfaction and quality of life when using a device but also examine issues concerning device human factor analysis (14,15) (e.g., pump malfunction, cracked/physically damaged device, battery problems, keypad problems, water damage, missing hardware/component, and set/site failure). Another issue that was addressed was education- and training-related issues (such as dealing with infusion set issues and using many of the pump features such as the bolus wizard). This information is useful for patients, the diabetes team, and engineers to enable a better CSII design in the future.Parental mastery of continuous subcutaneous insulin infusion skills and glycemic control in youth with type 1 diabetesMitchell K, Johnson K, Cullen K, Lee MM, Hardy OTDivision of Endocrinology and Diabetes,