Abstract
Introduction
This year, for our article, we have tried to include as diverse a range of articles as possible. The aim is to cover the latest technologies as usual, but also to cover back-to-basics articles addressing some of the issues faced by the many with diabetes as well as by the few. As such, our selection includes articles on injection technique, hopefulness and mealtime bolus deliveries, and skin problems associated with cannulas and sensors as well as articles on hybrid closed loop, continuous glucose monitoring, and acceptability of devices in real-life experience.
Audit data from around the world sadly continues to show very little improvement in glycemic outcomes for people with diabetes. This lack of improvement persists, despite concerted efforts, increasing availability, growing device range, and increasing complexity of diabetes technologies. As we enter the third decade of the 21st century, the human factors associated with diabetes technologies are arguably more important than ever.
As has often been stated, by us and others, technologies in and of themselves are rarely sufficient to facilitate the sustainable behavior change required for optimal diabetes outcomes. Although they demonstrate engineering and technical excellence, technologies are simply tools to be used as part of a broader diabetes management package. Collectively, along with expert advice, education, psychological support, self-management skills, and endurance, the wide range of technologies available play a crucial role central to that package.
Continued improvements to technical features and functionality of devices and systems continue to push the boundaries of excellence. What will be interesting for future devices is the extent to which users and developers are able to push beyond the imagery of what exists in terms of user interface and experience, into blue-sky thinking of what can be.
We have reviewed a range of technologies future, new, and established in the context of their impact on the lives of people with diabetes. We do this from the perspective of human factors important to effective uptake and continued use of technologies to ensure reduced burden of diabetes and optimization of glycemic control and quality of life. Acceptability, usability, device burden and benefits, visibility, and smooth integration into everyday living are all important factors that must be examined when considering the introduction of a new technology.
Included technologies cover continuous glucose monitoring systems—both externally worn and a novel implantable device, bolus calculator in self-monitoring of blood glucose device, remote monitoring of continuous glucose monitoring (CGM), and artificial pancreas systems. These represent a broad range of technologies currently available and coming to market in the near future. While novel technologies remain of great interest, it is important to remember existing technologies and how they can best be used to improve outcomes for people with diabetes, which sadly remain stubbornly suboptimal for many. We look forward with interest and optimism as the human factors associated with diabetes technologies continue to demand their place as central to success.
Key Articles Reviewed for the Article
Hansen EA, Klee P, Dirlewanger M, Bouthors T, Elowe-Gruau E, Stoppa-Vaucher S, Phan-Hug F, Antoniou MC, Pasquier J, Dwyer AA, Pitteloud N, Hauschild M
Pillalamarri SS, Huyett LM, Abdel-Malek A
Pettus JH, Kushner JA, Valentine V, Wood R, Pang C, Paranjape S, Berria R, Deluzio A, Edelman SE
Rini C, Roberts BC, Morel D, Klug R, Selvage B, Pettis RJ
Rachmiel M, Levy-Shraga Y, Gruber N, Pinhas-Hamiel O, Barash G, Pivko-Levy D, Landau Z
Messaaoui A, Tenoutasse S, Crenier L
Vesco AT, Jedraszko AM, Garza KP, Weissberg-Benchell J
Ng SM, Moore HS, Clemente MF, Pintus D, Soni A
Waldenmaier D, Zschornack E, Kalt L, Buhr A, Pleus S, Haug C, Freckmann G
Calkins-Smith AK, Marker AM, Clements MA, Patton SR
Adams RN, Tanenbaum ML, Hanes SJ, Ambrosino JM, Ly TT, Maahs DM, Naranjo D, Walders-Abramson N, Weinzimer SA, Buckingham BA, Hood KK
Christensen MO, Berg AK, Rytter K, Hommel E, Thyssen JP, Svensson J, Nørgaard K
Accuracy, satisfaction and usability of a flash glucose monitoring system among children and adolescents with type 1 diabetes attending a summer camp
Hansen EA1, Klee P2,3, Dirlewanger M2,3, Bouthors T4, Elowe-Gruau E4, Stoppa-Vaucher S4,5, Phan-Hug F4, Antoniou MC4, Pasquier J6, Dwyer AA1,7, Pitteloud N1,4,8, Hauschild M1,4
1Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland; 2Pediatric Endocrinology and Diabetes Unit, University Hospitals of Geneva, Geneva, Switzerland; 3Diabetes Center of the Faculty of Medicine, University of Geneva, Geneva, Switzerland; 4Pediatric Endocrinology, Diabetology and Obesity Unit, Lausanne University Hospital, Lausanne, Switzerland; 5Department of Pediatrics, Neuchâtel Hospitals, Neuchâtel, Switzerland; 6Institute of Social and Preventive Medicine, Lausanne, Switzerland; 7Boston College, William F. Connell School of Nursing, Chestnut Hill, MA; 8Service of Endocrinology, Diabetology and Metabolism, Lausanne University Hospital, Lausanne, Switzerland
Background
The goal of this research was to evaluate accuracy, satisfaction, and usability with the use of a flash glucose monitoring system in children and youth with type 1 diabetes (T1D) during participation in a diabetes summer camp.
Methods
Study participants comprised 66 children and youth (age 6–17 years) with type 1 diabetes recruited to participate in a 7-day medically supervised summer camp. Capillary blood glucose (BG) and flash glucose (FG) values were measured together at meals (breakfast, lunch, and dinner) and for any FG value <72 mg/dL (<4.0 mmol/L) during daytime, <108 mg/dL (<6.0 mmol/L) at nighttime, >270 mg/dL (>15.0 mmol/L) or when participant symptoms didn't match with sensor readings. Sensor-related issues were recorded and patients' and healthcare professionals' (HCPs) satisfaction was assessed.
Results
Flash glucose monitoring demonstrated satisfactory clinical accuracy compared with reference capillary BG values: 98.8% of values fell within the clinically acceptable zones (A and B) of the consensus error grid. Overall mean absolute relative difference was 16.7%±16.1%. Mean absolute difference (MAD), mean relative difference (MRD), and mean difference (MD) were calculated and the results indicated that across all glycemic ranges, flash glucose monitoring overestimated BG values. Both participants and HCPs reported high overall satisfaction with the device (91.7% and 95.0% respectively), although confidence scores for the system were much lower: 18.0% in participants and 40.0% for HCPs.
Conclusions
The flash glucose monitoring system demonstrated satisfactory clinical accuracy. But based on data from this study, the authors state that no decision should be made solely on the grounds of a single, nonverified, flash glucose value. The current study underscores the necessity for revised therapeutic education for patients/families and further research regarding the integration of sensor readings into clinical decision making.
Self-monitoring of blood glucose (SMBG) is highly accepted as a cornerstone of diabetes management. Intensive blood glucose control makes a significant contribution for preventing the onset of long-term complications (1). Advanced CGM technologies help users overcome the barriers to frequent SMBG including invasiveness, painful fingerpicks, interference with daily activities, and lack of discretion (2). Although the novel technology of the flash glucose monitoring system has recently been introduced as an alternative to CGM (i.e., longer sensor lifetime, absent need of calibration compared with some systems, and lower cost) there were only few studies examining reliability in pediatric population. Despite the high satisfaction rate, participants lacked confidence in the system. The authors speculate this might be due to the novelty of the device at the time of the study. Also, perceived discrepancies between FG and BG values could likely have influenced confidence in the system. However, there might be a more profound explanation. The flash system requires a shift in the decision-making process that stands at the base of SMBG measures. The authors suggest that no decision should be taken on the basis of a single, nonverified FG value alone. Glucose trend arrows as well as individual experiences of clinical signs should always be included in the interpretation of a given sensor value. In addition, utilizing complementary SMBG is recommended to confirm an FG reading prior to acting upon it. Intensive therapeutic education for patients and their families as well as further studies on the integration of sensor readings in clinical decision making is required. As increasing numbers of CGM systems become available, it is necessary to reframe the way in which data is viewed, interpreted, and acted upon. Increasing focus on trend arrows, rather than specific numbers, should be considered more fully and appropriate tailored advice provided in this regard.
Novel Bluetooth-enabled tubeless insulin pump: a user experience design approach for a connected digital diabetes management platform
Pillalamarri SS, Huyett LM, Abdel-Malek A
Insulet Corporation, Billerica, MA
Background
Medical device technology is advancing quickly, and patient demand for contemporary technologies for use in diabetes management is rising as well. Significant increases of the use of wireless technology and medical devices with complex, securely connected digital platforms mean that the needs and practices of end users are fundamentally important areas of interest.
Methods
This study details the user-centered approach implemented in the design and development of the Omnipod DASH Insulin Management System (Insulet Corp., Billerica, MA) Bluetooth-enabled locked-down Android device handheld controller (Personal Diabetes Manager [PDM]). Key design methodologies are outlined, including how the science of user experience (UX) was integrated into new agile product development, including heuristic evaluations of insulin pumps, iterative formative usability testing, information architecture studies, in-home ethnographic visits, participatory design activities, and interviews.
Results
More than 343 users took part in UX research and testing. This UX research was used to guide design decisions included updating the layout of critical data on the PDM home page, providing access to requested contextual information while a bolus is in progress, and creating an easy-to-understand visual of a 24-hour basal program. Task completion rates for comprehending data on the PDM home page were 87% or greater. Prior to limited market release, the design's System Usability Scale score was 84.4±13.4 (out of 100; n=37).
Conclusions
The UX procedure depicted in this report can be used as a blueprint for other medical technologies manufacturers that wish to upgrade technology products. Implementation of UX research methodologies will help ensure that new diabetes devices are safe, easy-to-use, and meet the needs of users.
This is a large study exploring the needs and behaviors of end users of a tubeless insulin pump and connected digital diabetes management platform. The study employs a wide range of methodologies to conduct a comprehensive assessment of the user-centered design approach of the system. Taking such an approach, the authors state that patient safety, usability, and effectiveness of the device are addressed in the science of user experience. It has long been argued that a gulf exists between the everyday technologies that people use, for example their smartphones, and the medical technological devices they must use or wear to support their diabetes self-management. While it is acknowledged that medical devices are subject to a rigorous process of development, it has long been reported in clinical trials that their contribution to the visibility of disease state has a detrimental effect on their quality of life. Further, such visibility can be a barrier to uptake and continued use of such systems. The ability to discreetly operate these devices remotely via a smartphone has opened up a wealth of opportunities (3). This study demonstrates the importance of applying equally rigorous methodology to the user experience of such systems and highlights the facilitators and challenges within that process. What is interesting is that the imagery from the participatory design workshops remains firmly within the “traditional” imagery of existing medical technological devices rather than real “blue sky” thinking of what could be with future technologies. Only when these “what if?” questions are asked will there be a monumental shift in what is.
Adjunct therapy in type 1 diabetes: a survey to uncover unmet needs and patient preferences beyond HbA1c measures
Pettus JH1, Kushner JA2, Valentine V3, Wood R4, Pang C4, Paranjape S5, Berria R5, Deluzio A5, Edelman SE6
1University of California San Diego, La Jolla, CA; 2McNair Interests, McNair Medical Institute, Houston, TX; 3Clinica La Esperanza, Albuquerque, NM; 4dQ&A–The Diabetes Research Company, San Francisco, CA; 5Sanofi US, Bridgewater, NJ; 6Veterans Affairs Medical Center, University of California San Diego, San Diego, CA
Background
Adjunct therapy may assist individuals with T1D in obtaining glycemic targets while relieving some of the side effects of insulin. A patient review was used to identify unmet needs in T1D therapy, patient attitude regarding therapy benefit/risk trade-offs, and patient preferences toward using an adjunct therapy.
Methods
In November 2017, 2,084 adult patients with T1D were asked to complete a quantitative review. “Jobs-to-be-done” and conjoint analyses were executed on review responses to identify unmet needs and the significance of treatment-related patient benefits and risks. A five-point Likert scale was used to assess the importance and satisfaction associated with patients' ongoing therapy and with gaps due to unmet needs. In the conjoint analysis, participants were requested to choose between “packages” of attributes for two doses of adjunct therapy (200 and 400 mg) and placebo, based on established benefits and side effects.
Results
Of 2,084 patients who received the survey, a total of 1,313 (63%) responded. Respondents identified their most considerable unmet needs to be simplification of treatment, lowering and/or maintaining glycated hemoglobin (HbA1c), reducing mental effort, and increasing time in range (TIR). Conjoint analysis demonstrated that diminutions in body weight and TIR had the highest attribute importance (25% and 18%, respectively). Most participants (93%) preferred the adjunct therapy (either dose) over placebo.
Conclusions
The results of this patient review emphasizes the significance of measures beyond HbA1c, such as treatment simplification and TIR, and spotlights patient preference for adjunct therapies that target unmet needs in T1D treatment.
Type 1 diabetes affects not only glycemic control, but also many aspects of a patient's life, including emotional well-being, quality of life, working ability, and social interactions (4,5,6). In addition, monitoring of blood glucose using multiple daily finger-stick measurements or continuous glucose monitoring (CGM) is recommended for better glycemic control. Interestingly though, many of the most important needs and preferences identified in the current study were measures beyond HbA1c. CGM users reported higher unmet needs scores than those not using CGM. For CGM users, the highest unmet needs scores were for treatment simplification, reducing mental effort, and improving TIR, whereas for non-CGM users, the greatest unmet need was lowering or maintaining HbA1c. It seems that the use of CGM helps users to better understand the importance of keeping target values for a longer period of time.
Evaluating the impact of human factors and pen needle design on insulin pen injection
Rini C1, Roberts BC1, Morel D2, Klug R1, Selvage B1, Pettis RJ1
1BD Technologies and Innovation, Research Triangle Park, NC; 2BD Clinical Development, Pont-de-Claix, France
Background
Very little data has been published quantifying how human factors (HF) and pen needle (PN) design affect delivery results of pen injection systems. Results are presented from a preclinical in vivo investigation of the effects of PN hub design and force applied against the skin during injection on needle penetration depth (NPD).
Method
Iodinated contrast agent was used to precisely measure injection depth. PN injections (20 μL; 2 IU, U-100 volume equivalent) were dispensed from four 32 G×4 mm PN devices (BD Nano 2nd Gen and three commercial posted-hub PN devices; n=75/device/force, 1,200 total) into the flank of Yorkshire swine across a range of clinically relevant application forces against the skin (0.25, 0.75, 1.25, and 2.0 lbf). The NPD, representing in vivo needle tip depth in subcutaneous tissue, was measured via fluoroscopic imaging of the deposited contrast agent.
Results
Across the range of applied injection forces, the re-engineered pen needle hub design of BD Nano 2nd Gen more closely achieved the 4 mm target NPD with significantly less variability (P=0.006) than commercial posted-hub PN devices.. An in silico probability model using NPD and average human tissue thickness measurements was used to calculate intramuscular injection risk. Analysis revealed a commensurate reduction of risk (∼2–8×) for BD Nano 2nd Gen compared with conventional PN hub designs.
Conclusions
Visualization of the injected contrast agent provided quantifiable variations in injection depth between identical labeled-length PN devices, indicating that hub style options as well as aspects of variable injection technique may influence injection depth accuracy and consistency. The reengineered hub design may minimize the influence of unintentional individual technique differences by improving target injection depth consistency and reducing intramuscular injection potential.
Injections remain the mainstay of diabetes self-management for most people and this is unlikely to change any time soon. In this study, 1,200 injections were completed over a multiweek period. The authors compare four equivalent needle length devices. Results showed quantifiable differences in injection depth between devices, and the authors concluded that hub design features, coupled with injection technique, may influence injection depth accuracy and consistency. They further conclude that the re-engineered hub design of the BD Nano second generation device may reduce the impact of such unintended differences. There are a number of human factors affecting injection technique including site accessibility or visibility, restricted or reduced hand dexterity, individual preference, perceived comfort, or learned behaviors of poor technique. This article is a timely reminder of the importance of assessing injection technique both at initiation of therapy as well as periodically thereafter to ensure that users continue to practice good technique and reduce the risk of ineffective dosing. It further reminds us to be mindful of factors such as technique, understanding, and learned behaviors when reviewing self-management tasks with patients.
Comparing insulin pump devices in real life: the AWeSoMe study group prospective experience
Rachmiel M1,2, Levy-Shraga Y2,3, Gruber N2,3, Pinhas-Hamiel O2,3,4, Barash G1,2, Pivko-Levy D2,5, Landau Z2,4,5
1Pediatric Endocrinology Unit, Assaf Harofeh Medical Center, Zerifin, Israel; 2Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; 3Pediatric Endocrine and Diabetes Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Tel Hashomer, Israel; 4Maccabi Health Care Services, Juvenile Diabetes Center, Raanana, Israel; 5Pediatric Endocrine and Diabetes Unit, E. Wolfson Medical Center, Holon, Israel
Background
The usage of insulin pumps in children with type 1 diabetes (T1D) has widened; nevertheless, data comparing devices remain rare. The authors explored glycemic control, technical difficulties, and quality of life (QOL) between continuous subcutaneous insulin infusion (CSII) of three companies.
Methods
This prospective observational trial is based on clinical data retrieved during 12 months of follow-up of pediatric patients who initiated pump therapy as part of their clinical care in four medical centers. The devices, fully reimbursed by the national health insurance, are as follows: MiniMed™ 640G, MiniMed Veo™, Animas Vibe, and Abbott OmniPod. Parameters investigated included dropout rate, glycated hemoglobin (HbA1c), mean self-monitoring of blood glucose (SMBG), total daily dose of insulin, pump setting parameters, body mass index, frequency of technical difficulties, significant skin reactions, and QOL.
Results
A total of 68 (60%) out of 113 children (mean age 9.1±4.1 years; 46% females), used Medtronic devices, 33 (29%) OmniPod, and 12 (11%) Animas devices. Twelve percent of the cohort stopped using the pump within the study period, with no difference according to device. There were no differences between groups regarding mean SMBG values (P=0.86), total daily dose of insulin (P=0.24), body mass index (P=0.87), level of insertion site pain or local reaction (P=0.51), technical problems (P=0.66), and QOL (P=0.38). Changes in HbA1c from study initiation to end were also not statistically significant for any of the devices: from 7.99%±1.14% to 7.93%±0.99% for Medtronic, from 7.71%±1.29% to 7.92%±1.38% for OmniPod, and from 8.75%±1.3% to 7.70%±1.33% for Animas (P=0.63).
Conclusions
CSII were comparable concerning glycemic control, weight gain, and satisfaction among children with T1D.
This study has identified that when patients with T1D and their parents select an insulin pump to suit their needs, they do not have evidence-based information to assist them in the decision-making process (not including information given by social media, agents of manufacturers, and healthcare providers). In light of the fact that no evidence-based superiority was found for one pump device over another, the authors conclude that patients should choose their insulin pump device according to convenience and lifestyle preferences. In addition to these findings, the rate of discontinuation of the pump and the relationship between pump use and different types of CGM were also examined. The diabetes team should assist patients and their parents in the decision-making process and make an informed decision based on evidence-based information and a combination of different aspects, such as psychological assessment of potential for stopping use of the pump and integration of CGM use. A greater emphasis on matching the device to the individual needs of each patient and their family will determine the discerning factors between devices in the context of human factors and lived experience.
Flash glucose monitoring accepted in daily life of children and adolescents with type 1 diabetes and reduction of severe hypoglycemia in real-life use
Messaaoui A1, Tenoutasse S1, Crenier L2
1Diabetology Clinic, Hôpital Universitaire des Enfants Reine Fabiola, Brussels, Belgium–Université Libre de Bruxelles, Bruxelles, Belgium; 2Department of Endocrinology, Hôpital Erasme, Brussels, Belgium–Université Libre de Bruxelles, Bruxelles, Belgium
Background
Flash glucose monitoring is covered by the Belgian public health insurance for type 1 diabetes since 2016. The goal of this research was to describe the use of flash glucose monitoring and diabetes results in type 1 diabetic pediatric population 1 year after reimbursement.
Methods
All patients had the choice to switch to flash glucose monitoring or to stay with self-monitoring of blood glucose (SMBG). Clinical data were gathered at baseline, at the next visit, and after 12 months; glucose profiles at next visit and after 12 months. Regression analyses were conducted to identify predictors of flash glucose monitoring acceptance and changes in metabolic control.
Results
A total of 334 participants were included, of whom 278 (83.2%) switched to flash glucose monitoring. They were younger (13.6 vs 15.2 years; P=0.012) and performed more SMBG testing at baseline than patients who did not switch (4.3 vs 4.1 tests daily; P=0.008). At the end of follow-up, the rate of severe hypoglycemia decreased by 53% in the group of flash users (P=0.012) while it remained stable in SMBG users. Median glycated hemoglobin did not change significantly in both groups. Among participants who switched to flash glucose monitoring, 15.8% reverted to SMBG after a median use of 5.3 months. Adverse events, diabetes duration, and flash utilization were independent predictors of the risk for reverting. Flash glucose monitoring-related adverse events were associated with a 5-fold increased risk to revert to SMBG (hazard ratio=5.12; P<0.0001).
Conclusions
Flash glucose monitoring is comparatively well accepted and reduces the risk of severe hypoglycemic events in the current study of children and adolescent's population. The system is more often discontinued in patients experiencing adverse events and with longer diabetes length.
This is an interesting article reporting the use of flash glucose monitoring and associated diabetes outcomes in children and adolescents with type 1 diabetes a year following reimbursement of the device. The results somewhat reflect those of previous device trials in terms of acceptability across the age ranges. Thirty percent of patients were still using the device after one year of follow-up. More than 15% of adolescent participants refused to switch to the flash system during the year of follow-up, reflecting the reality that many in this age range simply do not want the increased visibility of their diabetes. While the authors argue that flash glucose monitoring was best accepted in younger children, it is in fact the parents of these children making that decision. There were no significant differences in HbA1c, however a reduction in severe hypoglycemia was observed in the flash glucose monitoring group compared with the control group. Those that reverted to self-monitoring of blood glucose devices following the study scanned less and were less satisfied with the device. This study perhaps reinforces what is already known. Those that can and do engage with a device seem to benefit from it in either glucose control or psychosocial terms. For others, a different strategy is required.
Continuous glucose monitoring associated with less diabetes-specific emotional distress and lower A1c among adolescents with type 1 diabetes
Vesco AT1, Jedraszko AM1, Garza KP1, Weissberg-Benchell J1,2
1Department of Psychiatry and Behavioral Health, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL; 2Northwestern University Feinberg School of Medicine, Chicago, IL
Background
Limited research is available regarding the psychosocial impact of CGM and CSII among youth with T1D. The present study evaluates correlations between the use of specific diabetes technologies alone and in combination and both adolescent- and parent-perceived diabetes-specific distress and levels of A1c.
Method
Adolescents aged 12–18 years with T1D and their parents (N=1,040; primarily mothers) completed questionnaires their specific experiences with diabetes distress. Adolescent participants were classified according to technology use: CGM Alone, CSII Alone, CGM+CSII, or No Technology. ANOVA, regression, and Cohen's d were used to evaluate mean differences among technology groups on measures of diabetes distress and A1c levels. Groups were also assessed based on clinical elevations of distress.
Results
CGM use was correlated with less adolescent distress compared with the other three technology groups [No Technology (d=0.59), CGM+CSII (d=0.26), and CSII Alone (d=0.29)]. Results were similar but with smaller effect size for parent-reported distress, although CGM+CSII showed equivocal correlation with parent distress compared with No Technology (d=0.18). Higher A1c was significantly associated with higher levels of both adolescent- and parent-reported distress (r=0.30, P<0.001 and r=0.39, P<0.001 respectively). CGM Alone resulted in lower A1c compared with No Technology (d=0.48) and CSII Alone (d=0.37) and was associated with similar levels compared with CGM+CSII (d=0.03). CGM+CSII was more effective than CSII Alone (d=0.34). No Technology was correlated with clinical elevation of distress, especially for adolescents.
Conclusions
Technology use is correlated with lower adolescent distress and lower parent distress, although the effect is smaller for parents. CGM alone is correlated with lower adolescent and parent distress than either CSII or CGM+CSII. These results appear to be clinically meaningful based on cut scores for technology measures. CGM is correlated with lower A1c independent of the use (or nonuse) of CSII.
This study compared T1D technology use groups (CGM Alone, CSII Alone, CGM+CSII, and No Technology) in a large sample of adolescents and parents concerning their perceived diabetes-specific emotional distress and A1c. The results of this study are not consistent with findings from previous studies, reflecting the complexities surround this technology. In the current study CGM use was correlated with lower distress for both adolescents and their parents compared with patients who did not use technology, those who used with CSII, and those who used CSII alone. However, past studies have found that CGM use is associated with either no psychosocial improvements or increases in psychological burden (7 –9). The lack of consistency between the current study and previous studies suggests that with every diabetes technology, consideration of both advantages and disadvantages of device use and of individual preferences is necessary.
Continuous glucose monitoring in children with type 1 diabetes improves well-being, alleviates worry and fear of hypoglycemia
Ng SM, Moore HS, Clemente MF, Pintus D, Soni A
Paediatric Diabetes, Southport and Ormskirk Hospital NHS Trust, Ormskirk, UK
Background
There is limited published data concerning the psychological impact of using continuous glucose monitoring (CGM) among pediatric populations with type 1 diabetes mellitus on glycemic control, fear of hypoglycemia, and patient or carer well-being. The goal of this research was to assess the effects of CGM on each of these factors.
Methods
Children older than 12 years independently responded to the hypoglycemia fear survey (HFS). Parents and carers of children using CGM for a minimum of 12 months were requested to complete a modified version of the hypoglycemia fear survey for parents of young children (HFS-P) before and after CGM usage.
Results
Sixteen participants (8 boys) were included with median age of 13.5 years (2–17 years) and use of CGM for a minimum of 12 months. There was no significant improvement in the glycated hemoglobin after 12 months of CGM usage. Parents of all 16 participants completed the HFS-P survey. Of 12 young people eligible (age >12 years), 11 returned the HFS survey. Significant improvement was seen in both parental and patient fear of hypoglycemia after CGM (P<0.001 and P=0.003, respectively).
Conclusions
Usage of CGM was not associated with any significant improvement in glycemic control after 12 months; nevertheless, parents' and children's worry and fear of hypoglycemia were significantly reduced after the use of CGM. Larger studies on the psychological effects of CGM are merited.
This small but interesting study demonstrates significant improvement in both parental and child fear of hypoglycemia after CGM. It is important to note, however, that from the methodological point of view, the improvement in fear of hypoglycemia was measured by self-reported questionnaires. On the other hand, no significant improvement was found in HbA1c for the 12-month period of CGM usage. This is an important finding, since persistent high glucose levels is one of the most problematic behavioral characteristics associated with fear of hypoglycemia, as some parents maintain higher than recommended blood glucose levels in order to avoid hypoglycemia. It is possible to suggest that the use of CGM created a sense of confidence and control, expressed in self-reported improvement in the level of fear of hypoglycemia. In clinical practice, however, there remains a gap between the subjective experience of children and their parents and the need to achieve optimal blood glucose targets to reduce the risk of long-term diabetes-related complications. It is important to ensure that fear of hypoglycemia as well as the risks associated with maladaptive avoidance behaviors, are openly addressed in a collaborative, nonjudgemental way with families in order to prevent the initiation and/or preservation of avoidance symptoms such as maintaining high blood glucose levels.
First user experiences with a novel touchscreen-based insulin pump system in daily life of patients with type 1 diabetes experienced in insulin pump therapy
Waldenmaier D1, Zschornack E1, Kalt L2, Buhr A2, Pleus S1, Haug C1, Freckmann G1
1Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany; 2Ypsomed AG, Burgdorf, Switzerland
Introduction
Prior to its launch in Europe, a novel insulin pump system was examined under conditions of typical daily-life conditions for safety evaluation and user and assessment. This insulin pump uses prefilled cartridges and is targeted on easy handling.
Methods
An open, mono-center, single-arm study home use study was conducted between August and October 2016 in 35 adults with type 1 diabetes experienced in insulin pump therapy. Participants used the new insulin pump system under everyday conditions for approximately one month. Technical issues and safety parameters were evaluated throughout the study, and all participants completed poststudy questionnaires about the new trial pump, rating various aspects of the system after using it at home.
Results
All 35 participants completed the study as planned, using the system for a total of 1,013 days. Results indicated that 74% of the subjects were highly satisfied or quite satisfied with the new pump, especially with the pump design, easy handling, bolus delivery and basal rate settings, infusion set, and cartridge change. User responses also indicated areas for potential improvements, namely, the touchscreen, warnings and alarms, the blind bolus function, the availability of a bolus calculator (not available at time of study), and the cartridge size. No safety concerns arose from the analysis.
Conclusions
The majority of the users evaluating the system were satisfied with the new insulin pump system and the system was safe for use under daily conditions when used by this study population.
In the present study, users' satisfaction with a touch-screen insulin pump was examined in several areas such as handling the pump (i.e., general ease of operation, were the icons understandable and whether the touch screen was user-friendly); overall satisfaction with the functions of the pump (i.e., basal rate and bolus administration, programming and changing a basal rate profile, and switching between profiles); and reasons for additional infusion set changes (i.e., external influences, like pulled out, such as during change of clothes; unsticking of the adhesive; discomfort; and occlusion alarms). It is important to emphasize that while most users reported high satisfaction with the various issues, a significant number of users reported difficulties. The fact that around 26 percent of participants found the use of icons difficult to understand and fifty percent found it difficult to effectively use the touch screen raises the possibility of the problem of the “digital divide” (10) and its association with health literacy. In future studies, it is important to address the sociodemographic segmentation of populations who experience difficulty using diabetes technologies, particularly in terms of access to such systems and social determinants of health that influence uptake and continued use.
Hope and mealtime insulin boluses are associated with depressive symptoms and glycemic control in youth with type 1 diabetes mellitus
Calkins-Smith AK1, Marker AM2, Clements MA3, Patton SR4
1Clinical Psychology Program, University of Kansas, Lawrence, KS; 2Clinical Child Psychology Program, University of Kansas, Lawrence, KS; 3Pediatric Clinical Research Unit, Children's Mercy Hospital, Kansas City, MO; 4Division of Child Behavioral Health, University of Kansas Medical Center, Kansas City, KS
Abstract
Effective engagement to treatment demands is correlated with enhanced glycemic control and is especially problematic through adolescence for patients with type 1 diabetes mellitus (T1DM). Both glycemic control and adherence may be negatively influenced by poor psychological results in adolescence, such as depressive symptoms and low hopefulness. The goal of this study was to investigate correlations between the mealtime insulin bolus score (BOLUS), a more robust proxy measure of adherence than frequency of blood glucose monitoring or self-report, with depressive symptoms, hopefulness, and hemoglobin A1c (HbA1c). Ninety adolescents completed measures of hope (Children's Hope Scale) and depressive symptoms (Center for Epidemiologic Studies–Depression Scale), as well as lab-based measures of HbA1c and BOLUS. Higher scores for hope was correlated with lower levels of depressive symptoms, more frequent mealtime insulin boluses, and better glycemic control. Higher BOLUS behavior scores were correlated with lower depressive symptoms and more effective glycemic control. Both BOLUS behavior and hope independently and significantly influenced the relationship between depressive symptoms and HbA1c, suggesting a possible mediation. Since hope and BOLUS were each correlated with the relationship between depressive symptoms and glycemic control, once this relationship is confirmed in a longitudinal study, clinics may take into account the assessment hope and BOLUS among adolescents with high levels of depressive symptoms and consider further investigation of BOLUS behavior and hope as potential treatment goals to enhance glycemic control.
In this interesting study, the importance of finding effective measurement tools to measure adherence to diabetes regimen is highlighted. What appears unique about this study is the investigation of depression in terms of this association to mealtime boluses and glycemic control. How this information relates to broader diabetes management, life stressors, and nature of communication within routine clinical environments is less clear. There are methodological problems in utilizing self-report questionnaires or semistructured interviews. Previous research has found that these measures were burdensome to complete and subject to recall bias or inaccuracy. The tool used in this study (mealtime insulin bolus score, or BOLUS) is suggested to be a more robust proxy measure of adherence that uses objective data from insulin pump downloads to assess mealtime management behaviors, mitigating the need to rely on self-report. It is based on a score for giving boluses at selected hours of the day, based on objective data from the pump. However, the authors of the article did not give up on the subjective perspective of pump users and tested their level of hope as a resilience to burnout and depression resulting from coping with diabetes as a chronic disease.
Psychosocial and human factors during a trial of a hybrid closed loop system for type 1 diabetes management
Adams RN1, Tanenbaum ML1, Hanes SJ1, Ambrosino JM2, Ly TT1,3, Maahs DM1, Naranjo D1, Walders-Abramson N4, Weinzimer SA2, Buckingham BA1, Hood KK1
1Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA; 2Yale University School of Medicine, New Haven, CT; 3School of Paediatrics and Child Health, The University of Western Australia, Crawley, Western Australia; 4Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, CO
Background
Hybrid closed loop (HCL) systems are designed to automate insulin delivery to achieve better outcomes for T1D patients results and to decrease patient burden and distress. Because the systems only automate some facets of diabetes care, psychosocial and human factors still remain an important consideration in their use. Thus, the authors investigated whether psychosocial and human factors (i.e., distress related to diabetes management, fear of hypoglycemia, and technology attitudes) would (1) change after using the system and (2) forecast glycemic outcomes during the trial.
Subjects and Methods
Fourteen adults and 15 adolescents with T1D participated in a multisite clinical trial of an investigational version of the MiniMed™ 670G system (Medtronic, Northridge, CA) over 4–5 days in a semisupervised outpatient setting. Users completed surveys assessing psychosocial and human factors before beginning the HCL system and at the conclusion of the study. t-Tests and regression analyses were conducted to examine whether these factors changed following trial exposure to the HCL system and predicted glycemic outcomes during the trial.
Results
Diabetes management distress were reduced and diabetes technology attitudes became more positive over the trial period; however, fear of hypoglycemia did not change over the trial period. There was a tendency toward greater pretrial management distress predicting less time in range during the trial, controlling for time in range before the trial.
Conclusions
Results imply that this system is promising for improving technology attitudes and reducing management distress. Psychosocial factors, such as management distress, may negatively impact glycemic outcomes and should be a priority area for future examination.
In this study we can see the continued important trend of examining the psychosocial and human factors that influence and result from the use of diabetes technology. The human factor may be influenced by the use of example technology, sense of load, discontinuation of the device, and, of course, improving the level of glycemic control. However, it is important to remember that technology enhancement cannot be relied upon as an exclusive factor affecting the human factor. This study found no significant effect of technology improvement (especially at night) on the fear of hypoglycemia. Treatment within a multiprofessional team and with emphasis on providing evidence-based psychological tools remains a significant factor in assisting diabetes patients in parallel with technological improvement. The short duration of the study may mask true burden or benefit experienced by participants which may become clearer over a longer period of time. Only longer use will shed light on whether users are able/willing to meet the demands of the system and whether hoped for benefits actually materialized.
Skin problems due to treatment with technology are associated with increased disease burden among adults with type 1 diabetes
Christensen MO1,2, Berg AK1,3, Rytter K2, Hommel E2, Thyssen JP4, Svensson J1,3, Nørgaard K2,5
1University of Copenhagen, Copenhagen, Denmark; 2Steno Diabetes Center Copenhagen, Gentofte, Denmark; 3Copenhagen Diabetes Research Center (CPH-DIRECT), Department of Pediatrics, Copenhagen University Hospital, Herlev, Denmark; 4Department of Dermatology and Allergy, Copenhagen University Hospital, Hellerup, Denmark; 5Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark
Background
In a 4-month follow-up survey, the authors investigated whether treatment with insulin pump therapy and/or CGM in adults with T1D was correlated with sustained skin problems and whether skin problems were correlated with diabetes-related emotional distress.
Methods
A total of 111 adults filled in a follow-up questionnaire concerning skin problems as a consequence of CSII and/or CGM sensor use. The questionnaire included a patient-reported outcome measure of diabetes-related distress, namely the Problem Areas in Diabetes (PAID) scale.
Results
Fifty-one (46.0%) participants reported current visible skin problems caused by CSII or CGM use. Of these, 34 (66.7%) had previously experienced skin problems more than 4 months earlier. Seventy-two (64.9%) participants reported skin problems as a result of CSII use, whereas 38 (74.5%) reported skin problems due to CGM use at some time. Itching was the most common complaint. CSII-related itching was associated with a mean PAID score >20 (P=0.01), and patients with more than one skin problem had an elevated PAID score compared with those with one or no skin problems (P=0.006).
Conclusions
More than half of participants using CSII, CGM, or both had reported skin problems during 4 months of follow-up that were correlated with increased diabetes distress. Skin problems represent a persistent health problem affecting diabetes-specific emotional distress.
Skin irritations including itching problems are, as the authors of the article emphasize, one reason why people with T1D choose to discontinue treatment with CSII and/or CGM (11). One of the interesting findings in this article is the significant increase in skin itching reported over 4 months. The authors suggest that the increase in skin problems from baseline to follow-up may be because of increased awareness arising from participation in the baseline study. However, another possible explanation can be offered. As found in this study, diabetes-related emotional distress is associated with device-related skin problems. Many studies indicate a sense of burden in the use of diabetes technology. Users who experience burden may be more aware of skin problems than users who experience a more positive CGM/CSII experience. The reality remains that any system must be usable daily with minimum burden and maximum benefit. The presence of skin irritations can be very uncomfortable and painful. Whilst various potential solutions exist in terms of barriers between the sensor and the skin, it is clear that for many users an acceptable solution remains elusive.
Footnotes
Author Disclosure Statement
No competing financial interests exist.