Abstract
Introduction
Increasingly, the literature is turning to the practical aspects of living with diabetes technologies as well as the clinical benefits. The benefits of diabetes technologies and devices have been well reported over recent years, both from the glycemic control and the quality-of-life perspectives. Much of the early research, however, was conducted with early adopters and technology enthusiasts who sought out such devices. As technologies become more widespread and are introduced more broadly to individuals living with diabetes, there is a broader range of views and experiences in terms of technology adoption and its impact on everyday life.
Diabetes devices are unlike medical solutions in other health areas. Unlike a pacemaker, for example, all diabetes devices require some degree of interaction by the wearer/user. The level of such interactions has a differential personal burden both for the individual and in the context of their relationships. Perspectives of school nurses on do-it-yourself automated pancreas systems are an example of reliance on a third party in the context of everyday activities being crucial. Similarly, data sharing of continuous glucose monitoring systems brings both benefits and potential pitfalls that should be considered carefully at the outset.
As can be seen in the articles included in the Human Factors article this year, the ultimate goal of people living with diabetes is to reduce the burden of disease. The additional burdens created with the use of diabetes devices cannot be underestimated and, as always, it's a trade-off between benefits and burdens to balance the seesaw. Efforts to reduce physical burden and mental effort and to make systems discreet are necessary as new systems are developed. As systems become more advanced, there is an opportunity to move beyond glycemic control so that users are able to maximize the benefits of diabetes devices while reducing associated hassles. The tipping point will be different for everyone, but steps in the right direction will enable that tipping point to be identified and managed more successfully. By doing so, the opportunities for all people with diabetes to benefit will increase.
In order to achieve the ultimate goal, a standardized consensus of patient-reported outcome measures is necessary across diabetes throughout the lifespan. Only then will a biopsychosocial model of health care be realized.
Key Articles Reviewed
Youngkin EM, Majidi S, Noser AE, Stanek KR, Clements MA, Patton SR
Pals RAS, Hviid P, Cleal B, Grabowski D
Shepard JA, Breton M, Nimri R, Roberts JTF, Street T, Klonoff D, Barnard-Kelly K
Elbalshy MM, Styles S, Haszard JJ, Galland BC, Crocket H, Jefferies C, Wiltshire E, Tomlinson P, de Bock MI, Wheeler BJ
March CA, Oyetoro R, Adams J, Rodriguez H, Albanese-O'Neill A
Polonsky WH, Fortmann AL
Murata T, Kuroda A, Matsuhisa M, Toyoda M, Kimura M, Hirota Y, Kato K, Sawaki H, Tone A, Kawashima S, Okada A, Watanabe T, Nirengi S, Suganuma A, Sakane N
Divan V, Greenfield M, Morley CP, Weinstock RS
Commissariat PV, Roethke LC, Finnegan JL, Guo Z, Volkening LK, Butler DA, Dassau E, Weinzimer SA, Laffel LM
Hood KK, Laffel LM, Danne T, Nimri R, Weinzimer SA, Sibayan J, Bailey RJ, Schatz D, Bratina N, Bello R, Punel A, Calhoun P, Beck RW, Bergenstal RM, Phillip M for the FLAIR Study Group
Kudva YC, Laffel LM, Brown SA, Raghinaru D, Pinsker JE, Ekhlaspour L, Levy CJ, Messer LH, Kovatchev BP, Lum JW, Beck RW, Gonder-Frederick L, iDCL Trial Research Group
Continuous Glucose Monitoring Decreases Hypoglycemia Avoidance Behaviors, But Not Worry in Parents of Youth with New Onset Type 1 Diabetes
Youngkin EM1, Majidi S1, Noser AE2, Stanek KR1, Clements MA3, Patton SR4
1University of Colorado Anschutz Medical Campus, School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, Aurora, CO; 2University of Kansas, Clinical Child Psychology, Lawrence, KS; 3Children's Mercy Hospital & Clinics, Kansas City, MO; 4Nemours Children's Health System, Jacksonville, FL
Background
Currently available studies demonstrate that hypoglycemia fear (HF) is prevalent in parents of children with type 1 diabetes (T1D). The authors investigated parental HF in the T1D recent-onset period and assessed whether continuous glucose monitoring (CGM) adoption can be associated with improved outcomes of parental HF.
Methods
In TACKLE-T1D, a prospective study of 5- to 9-year-olds with newly diagnosed T1D, parents filled in the Hypoglycemia Fear Survey-Parents (HFS-P) at baseline (T1) and 6 (T2) and 12 (T3) months after baseline. The HFS-P measures worry about hypoglycemia (HFS-Worry score) as well as hypoglycemia avoidance behaviors (HFS-Behavior score). The authors noted CGM start dates for adolescents during the same time period through medical record review.
Results
Between T1 and T2, 31 youth (32.3%) initiated CGM therapy, and between T2 and T3, an additional 17 youth (17.7%) began using CGM, leaving 48 youth who never initiated CGM therapy (50%) in the recent onset period. Parents reported moderate HFS-Worry scores at T1 (32.9±11.9), which increased between T1 and T2 (37.6±11.4, P < .001) and plateaued between T2 and T3 (37.7±12.4, P =.89). In contrast, parental HFS-Behavior scores decreased between T1 (33.1±5.8) and T2 (32.2±6.0, P =.005) and plateaued between T2 and T3 (32.2±6.0, P =.95). Baseline HFS-Behavior and HFS-Worry scores were associated with increased adoption of CGM between T1 and T2 and between T2 and T3, respectively. Parents of children starting CGM therapy between T1 and T2 demonstrated the largest decrease in HFS-Behavior scores (P =.03).
Conclusions
Starting off CGM therapy within the first 12 months of T1D may assist in diminishing parents' hypoglycemia avoidance behaviors, although it has little influence on parents' hypoglycemia worry.
Comments
The diagnosis of a child's diabetes has frequently been referred to be a moment of severe psychological stress for the child as well as for their parents, as it requires adaptation to a significant change in family life. Therefore, in order to treat pediatric chronic diseases, both children and parents must modify their mindset as well as their family's lifestyle. The onset of type 1 diabetes generally comes on suddenly, requiring families to make numerous life changes at once and within a relatively short period of time. This is also known to cause stress in families and may exacerbate any member's feelings of imbalance and loss of normalcy at this time. Managing these life adjustments for parents of newly diagnosed children can seem onerous and, in some cases, impossible. Adolescents with newly diagnosed T1D are vulnerable to extreme glycemic variability as caregivers learn T1D management and learn to balance insulin injections with their child's carbohydrate intake. The combination of external insulin injections and endogenous insulin release may increase the possibility that a child will experience a hypoglycemic event. Consequently, parents may experience fear of hypoglycemia and can be overprotective. It could be hypothesized that the transition to CGM would help the parents to reduce their own fear of a hypoglycemic event. Given the above, the results of the current study could seem somewhat surprising. However, behavior and fear may and should be seen as two components that are not necessarily dependent on each other. While it is possible to see an improvement in protective behavior after the connection to the CGM, parents still experience continuous anxiety for their child that is fueled by the uncertainty and difficulty associated with caring for a child with diabetes.
Demanding Devices – Living with Diabetes Devices as a Preteen
Pals RAS1,2, Hviid P2, Cleal B1, Grabowski D1
1Diabetes Management Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark; 2Department of Psychology, University of Copenhagen, Copenhagen K, Denmark
Abstract
Background
Diabetes technology plays a significant role in the everyday lives of children with type 1 diabetes (T1D). Yet not much emphasis is given to children's experiences with these technologies. More than that, little is known about psychosocial aspects of technology use during children's transition to adolescence. The goal of this study was to examine how children with T1D view, understand, and utilize diabetes technologies in their everyday lives.
Methods
Data were gathered from interviews with 18 children with T1D aged 10–14 years (preteens). The interviews were administered between March 2019 and August 2019 in Denmark. Photos were used as probes to facilitate discussion and reflection about issues preteens found significant. The study was informed by a technology-in-practice perspective to underscore how diabetes technologies were embedded in practices of use. The analysis focused on insulin pumps and technologies for continuous glucose monitoring (CGM).
Results
The authors found that these technologies introduced tensions regarding dependence and independence, wanted and unwanted attention, worries and peace of mind, treatment and care, visibility and invisibility, and control and loss of control. The authors combined the tensions into the following three themes that characterized the preteens' relationship with diabetes technology: 1) demanding devices, 2) the social context of using diabetes technologies, and 3) care and support through data. The authors report that the results indicate the need for investigators and clinicians to engage with the social and emotional aspects of living with diabetes technologies.
Conclusion
Significantly, this entails being aware of the underlying standards of diabetes technologies and how these inform care in preteens with T1D.
Comments
Significant social and emotional growth gives preteens an increasing sense of independence. This feeling of independence means they place greater importance on the world outside their family. They have greater involvement in school, friendships, and extracurricular activities. The current study shows that the preteens are taking a more active role in utilizing diabetes technologies to their everyday lives. Recent studies (1) demonstrated that children with chronic illness modified care practices in line to their own interests. However, managing diabetes technologies can require a lot of effort. The user has to learn how to use them and to customize them to their own body. In addition, dealing with the peer group is of great importance at this age and thus poses many challenges for the use of diabetes technologies, particularly in terms of visibility of diabetes. The growing need of the young adolescents for independence is sometimes in conflict with the fact that they are still relatively young and often need support to optimally manage their diabetes on their own. For example, the preteens may want their parents to help them managing their glucose levels but simultaneously will insist on their boundaries. The authors suggest a transition to a different mode of communication between parents and children, based more on mutuality and negotiating with the preteen. Once again it can be seen that diabetes technologies cannot be separated from the consideration of the child's developmental stage, the social challenges they face, and communication with their parents and their environment.
User and Healthcare Professional Perspectives on Do-It-Yourself Artificial Pancreas Systems: A Need for Guidelines
Shepard JA1, Breton M2, Nimri R3, Roberts JTF4, Street T5, Klonoff D6, Barnard-Kelly K7,8
1Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA; 2Center for Diabetes Technology, University of Virginia, Charlottesville, VA; 3Jesse 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; 4Birmingham Law School, University of Birmingham, UK; 5Diabettech Ltd, London, UK; 6Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA; 7BHR Limited, Fareham, Hampshire, UK; 8Faculty of Health & Social Science, Bournemouth University, Dorset, UK
Abstract
An increasing number of people who have type 1 diabetes are opting for do-it-yourself artificial pancreas systems (DIY APS) to help manage their diabetes. Observational and self-report data of glycemic benefits of DIY APS are promising; however, without rigorous clinical trials or regulation from governing bodies, liability and user safety continue to be central concerns for stakeholders. Despite DIY APS having been used for several years now, there are no guidelines to help users and health-care professionals in addressing DIY APS use in everyday clinical care. This commentary reports key stakeholders' perspectives presented at the annual Advanced Technologies and Treatments in Diabetes conference in February 2020. Important considerations to inform the development of clinical care guidelines are also given to generate further debate.
The Effect of Do-It-Yourself Real-Time Continuous Glucose Monitoring on Psychological and Glycemic Variables in Children with Type 1 Diabetes: A Randomized Crossover Trial
Elbalshy MM1, Styles S2, Haszard JJ2, Galland BC1, Crocket H3, Jefferies C4,5, Wiltshire E6,7, Tomlinson P, de Bock MI8,9, Wheeler BJ1,10
1Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, Otago, New Zealand; 2Department of Human Nutrition, University of Otago, Dunedin, New Zealand; 3Te Huataki Waiora School of Health, University of Waikato, Hamilton, New Zealand; 4Paediatric Endocrinology, Starship Children's Health, Auckland, New Zealand; 5Liggins Institute, University of Auckland, Auckland, New Zealand; 6Department of Paediatrics and Child Health, University of Otago Wellington, Wellington, New Zealand; 7Paediatrics and Child Health, Capital and Coast District Health Board, Wellington, New Zealand; 8Department of Paediatrics, University of Otago Christchurch, Christchurch, New Zealand; 9Department of Paediatrics, Canterbury District Health Board, Christchurch, New Zealand; 10Paediatric Endocrinology, Southern District Health Board, Dunedin, New Zealand
This manuscript is also discussed in DIA-2023-2508, page S-118.
Background
Continuous glucose monitoring (CGM) can help people with type 1 diabetes (T1D) reduce fear of hypoglycemia (FOH) and have better glycemic control. Currently, there is no research on the use of do-it-yourself real-time continuous glucose monitoring (DIY RT-CGM) on psychological and glycemic outcomes.
Methods
Child-parent dyads were recruited for a multicenter randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2–13 years. Families received either 6 weeks of DIY RT-CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), then went through a 4-week washout period, and then were crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics as well as a range of other psychosocial measures.
Findings
Fifty-five child-parent dyads were recruited. The children's mean age was 9.1±2.8 years. Although there was no effect on parental FOH (−0.1 [95%CI, −0.3 to 0.1; P=.4]), time-in-range (TIR) (3.9–10 mmol/L) was significantly higher with DIY RT-CGM than with isCGM (54.3%±13.7% vs 48.1%±13.6%); the mean difference was 5.7% (95% CI, 1.8%–9.6%; P<.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT-CGM compared to isCGM; the mean difference was 5.3 (95% CI, 2.3%–8.2%; P<.001).
Conclusion
Compared to isCGM, DIY RT-CGM did not have a stronger positive impact on FOH levels; however, TIR and parental satisfaction with diabetes treatment were significantly better. This indicates that in the short term, DIY RT-CGM seems safe and may offer families some clinically important advantages over isCGM.
Comments
The “We are not waiting” movement epitomizes patient-driven innovation with DIY systems used by many people with type 1 diabetes over recent years. However, despite this growth in use, there remain no guidelines to assist health-care professionals in how they are able to support patients using DIY systems within routine care. There have been mixed results in the literature about glycemic and psychological aspects of DIY system use. The article by Elbalshy and colleagues reflects this ambiguity with improved time in glycemic range and treatment satisfaction; however, there was no improvement in parental fear of hypoglycemia, and only two-thirds (67%) of participants trusted the readings from the device. Furthermore, loss of connectivity was a problem; three-quarters (76%) of participants reporting loss of connection between the phone and DIY RT-CGM, while glucose threshold alerts were turned off at some stage by over a third of participants (39%) during the day and 31% during the night. Alarms, it seems, continue to be a double-edged sword with diabetes technologies.
A lot is said about “off-label” use of devices, and examples given when similarities exist with other therapies. However, the fact remains that people using these systems do so at their own risk and remain unprotected by legal or regulatory frameworks. In an attempt to address these shortcomings, a consensus statement was published by an international collaboration of health-care professionals and legal advisors in the Lancet in early 2022 providing practical guidelines for health-care professionals. The guidelines provide recommendations for stakeholders around medico-legal and ethical support. However, these are complex issues that are difficult to unpick and are likely contributing to the fact that, to date, regulatory and clinical guidelines remain absent.
School Nurse Perspectives on Do-It-Yourself Automated Pancreas Systems in the School Setting
March CA1, Oyetoro R2, Adams J2, Rodriguez H3, Albanese-O'Neill A3
1Division of Pediatric Endocrinology and Diabetes, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA; 2Department of Pediatrics, University of Florida, Gainesville, FL; 3USF Diabetes and Endocrinology Center, University of South Florida, Tampa, FL
Abstract
Background
Do-it-yourself (DIY) artificial pancreas systems (APSs) are becoming more popular among children with type 1 diabetes. Not much is known about how school systems provide care for children who use DIY APSs, and available guidance for schools is restricted.
Method
This study explored school staff perspectives on DIY APSs through a national survey of school nurses about their present practices, beliefs, and attitudes toward DIY APSs.
Results
Although one-quarter (23%) of school nurses reported experience with DIY APSs in school, nearly half (46%) had no prior knowledge of this new technology. Most of the nurses (82%) reported that children should be allowed to use DIY APSs in school, although there was less consensus about school nurse responsibilities with these devices. Qualitative responses added context regarding potential barriers, including the need for more informed guidelines and training and fears of liability.
Conclusion
Future development of school guidelines for DIY APSs is necessary and should incorporate stakeholder perspectives.
Comments
The routine care of children and adolescents with type 1 diabetes is based on wide support circles. Since children spend a significant part of their waking hours in educational settings, it goes without saying that, in additional to parents and primary caregivers, kindergarten and school nurses have a central role in providing care for children with diabetes in the various educational settings. Because of this, it is very important to know the point of view of the school and kindergarten nurses regarding diabetes technologies. Previous studies (2,3) on this subject presented a complex situation. Nurses reported gaining better recognition and assimilation of the use of diabetes technologies compared to past couple of years. However, several obstacles remained, such as poor communication between parents and nurses. The introduction of DIY technologies for the treatment of children with diabetes and their growing popularity poses another challenge for their integration into educational settings, as nearly half of the nurses who participated in the current study had no prior knowledge of this new technology. However, it is encouraging to see that most of the participants expressed acceptance and openness regarding the possibility of allowing the use of this technology for children in the education system. It seems that along with the challenge, there is also an opportunity to start the acquaintance and assimilation of the nurses with this new technology in real time and in a way that will allow a friendly attitude toward the use of technology.
Impact of Real-Time CGM Data Sharing on Quality of Life in the Caregivers of Adults and Children with Type 1 Diabetes
Polonsky WH1,2, Fortmann AL3
1Behavioral Diabetes Institute, San Diego, CA; 2Department of Medicine, University of California, San Diego, CA; 3Scripps Whittier Diabetes Institute, La Jolla, CA
Background
The aim of this study is to learn about caregiver experiences with real-time continuous glucose monitoring (RT-CGM) data sharing, including its effects on health outcomes and quality of life (QoL).
Methods
Parents of children with type 1 diabetes (T1D) (n=303) and spouses/partners of T1D adults (n=212) who were using the Dexcom G5 Mobile or G6 RT-CGM system and who were actively following their child's or partner's RT-CGM data filled in a survey investigating their perceived value of data sharing, the effect of sharing on their own QoL and their child's or partner's health, and how they used RT-CGM data to support their child's or partner's T1D management. Regression analyses examined whether their behavior was associated with reported changes in QoL and health outcomes.
Results
Respondents were predominantly non-Hispanic White (91.1% parents; 88.7% partners), female (78.2% parents; 54.7% partners), and college-educated (65.3% parents; 61.8% partners). The majority reported that data sharing had enhanced hypoglycemic confidence (97.7% parents; 98.1% partners), overall well-being (60.4% parents; 63.2% partners), and sleep quality (78.0% parents; 61.3% partners). Of note, three positive caregiver actions were broadly consistent and significant predictors of QoL and health benefits for both parents and partners: celebrating success related to glycemic control, providing encouragement when glycemic control is challenging, and teamwork discussions about how the caregiver should respond to out-of-range values.
Conclusions
Parents of children whose RT-CGM data were shared with them had many QoL and health benefits. The degree of benefits was influenced by the collaborative actions taken by caregivers to support their child's or partner's diabetes management. To decide the most useful strategies for collaborative data sharing, longitudinal studies are required.
Comments
The current study sheds light on the essential connection between advances in diabetes technologies and the relationships between diabetes patients and their caregivers. The issue of remote data sharing through continuous glucose monitoring (RT-CGM) systems helps to clarify this point. Will it have a positive or negative effect on the relationship between diabetes patients and their caregivers? The experience of the diabetes caregivers has been proven many times to be extremely significant not only for their own quality of life but also to the patients' quality of life and even for the quality of their diabetes management (4,5)
Predictive Factors of the Adherence to Real-Time Continuous Glucose Monitoring Sensors: A Prospective Observational Study (PARCS STUDY)
Murata T1, Kuroda A2, Matsuhisa M2, Toyoda M3, Kimura M3, Hirota Y4, Kato K5, Sawaki H6,7, Tone A8,9, Kawashima S10, Okada A11, Watanabe T1, Nirengi S12, Suganuma A12, Sakane N12
1Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan; 2Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan; 3Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan; 4Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; 5Diabetes Center, National Hospital Organization Osaka National Hospital, Osaka, Japan; 6Diabetes Center, Arisawa General Hospital, Hirakata, Japan; 7Sawaki Internal Medicine and Diabetes Clinic, Takatsuki, Japan; 8Diabetes Center, Okayama University Hospital, Okayama, Japan; 9Department of Internal Medicine, Okayama Saiseikai General Hospital, Okayama, Japan; 10Kanda Naika Clinic, Osaka, Japan; 11Okada Clinic, Fukuoka, Japan; 12Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Background
There is insufficient information on factors related to continuous glucose monitoring (CGM) adherence.
Materials and Methods
The researchers recruited 46 participants who had type 1 diabetes and were using continuous subcutaneous insulin infusion (CSII) but not CGM. The participants' characteristics and diabetes-related quality of life (QOL) were assessed at baseline and 1 year after they started using CGM. To be considered adherent, participants needed to wear their sensor for ≥60% of the time.
Results
The mean age of the 46 participants was 44.1±15.0 years, the mean glycohemoglobin (HbA1c) was 7.7±1.0%, and 60.9% of participants were defined as adherent. The length of using CSII was longer in the adherent group, and the degree of diabetic retinopathy was significantly different. There were no significant differences in age, frequency of self-monitoring of blood glucose, or Hypoglycemia Fear Survey (HFS-B for behavior, HFS-W for worry) scores at baseline between the adherent and nonadherent groups. The Problem Areas in Diabetes (PAID) score at baseline was significantly higher and the total CSII-QOL score at baseline was significantly lower in the adherent group. The usage of dual-wave bolus significantly increased in the adherent group (34.6% baseline, 61.5% at 1 year; P =.016), but not in the nonadherent group (33.3% at baseline and at 1 year; P > .999). The HbA1c level showed a significant improvement in the adherent group (7.8% at baseline, 7.3% at 1 year; P < .001), but not in the nonadherent group (7.5% at baseline, 7.2% at 1 year; P =.102).
Conclusions
Higher adherence to CGM sensors may be correlated with severe emotional burden of diabetes and a worse QOL in relation to CSII at baseline.
Perceived Burdens and Benefits Associated with Continuous Glucose Monitor Use in Type 1 Diabetes Across the Lifespan
Divan V1, Greenfield M1, Morley CP2, Weinstock RS1
1Department of Medicine, Upstate Medical University, Syracuse, NY; 2Public Health and Preventive Medicine, Upstate Medical University, Syracuse, NY
Background
Although continuous glucose monitors (CGMs) may assist people with type 1 diabetes (T1D) in achieving better glycemic control, these systems are underused. To gain a better understanding of the reasons for this underuse, the researchers evaluated CGM burdens and benefits, as perceived by users and nonusers; all participants had type 1 diabetes.
Methods
Questionnaires on burdens (BurCGM) and benefits of CGM (BenCGM) were filled during T1D outpatient visits (N=1334) from February 2019 to February 2020. Mean scores were calculated (scale 1 to 5; higher scores reflect greater perceived burdens/benefits). Data from medical records, including glycated hemoglobin (HbA1c), were obtained within 3 months of the visit.
Results
Individuals of all ages using CGM reported greater benefits and less intense burdens (mean scores 4.48 and 1.69, respectively) when compared with those who were not using CGM (mean score 4.19 and 2.35, respectively) (P<.001). There were no differences in burdens or benefits by sex. Non-CGM users aged ≥50 years had higher mean BurCGM scores than those aged <50 years (P=.004); the cost was the greatest barrier in those aged ≥27 years. Other burdens were readings not trusted, painful to wear, and takes too much time to use. For those aged ≥65 years, 18.5% of nonusers but only 3.1% of users agreed with “it was too hard to understand CGM information.” In addition, 21.4% of nonusers but only 7.7% of users agreed that CGM causes too much worry. Mean HbA1C was lower in CGM users (8.1%) than in non-CGM users (mean A1c 9.1%; P<.001).
Conclusions
Nonusers felt that CGM was more burdensome and less beneficial than did users, although there were differences in concerns seen across age groups. Lower costs and age-appropriate education are required to deal with these barriers.
Comments
These two studies discuss different aspects of the experience of the burden associated with the use of CGM of what appear to be two different groups of patients. It is interesting to see that diabetes distress motivated patients to be more adherent to CGM use but, at the same time, did not improve the level of distress. On the other hand, patients of all age groups reported a burden caused by the high costs of the CGM and the difficulty in understanding the information. It seems that the way to deal with these difficulties is to personally accompany the patients through their difficulties. It should not be expected that the mere use of diabetes technology, however sophisticated it may be, will provide the full answer to improving the burden caused by chronic diabetes treatment. Tailoring a treatment plan that addresses difficulties related to technology use, such as burnout, difficulty in understanding information, or high costs, may contribute to improving the quality of life, improving balance, and preventing burnout.
Youth and Parent Preferences for an Ideal AP System: It Is All About Reducing Burden
Commissariat PV1, Roethke LC1, Finnegan JL2, Guo Z1, Volkening LK1, Butler DA1, Dassau E1,3, Weinzimer SA2, Laffel LM1
1Section on Clinical, Behavioral, and Outcomes Research, Joslin Diabetes Center, Boston, MA; 2Department of Pediatrics, Yale University School of Medicine, New Haven, CT; 3Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA
Background
As diabetes technologies advance to provide better glucose control, user priorities may shift toward lessening the burdens and increasing the ease of system use. Using qualitative methods, the researchers investigated the features that youth and their parents would prefer in an ideal artificial pancreas (AP) system.
Methods
The authors conducted semistructured interviews with 39 youth, ages 10–25 years, and 44 parents. Interviews were audio-recorded, transcribed, and coded using thematic analysis.
Results
Youth (79% female, 82% non-Hispanic White) were (mean ± SD) ages 17.0±4.7 years, had diabetes for 9.4±4.9 years, and had HbA1c levels of 8.4±1.1%; 79% were pump treated, and 82% used CGM. Of parents, 91% were mothers and 86% were non-Hispanic white. Participants suggested various ways in which an ideal AP system could reduce physical and emotional burdens of diabetes. Physical burdens could be minimized by lessening user responsibilities to manage glucose for food and exercise and to wear or carry devices. Emotional burden could be reduced by mitigating negative emotional reactions to sound and frequency of alerts while increasing feelings of normalcy. Youth and parents varied in their suggestions to reduce emotional burden. Participants offered features that would improve glycemia, but nearly always in the context of how the feature would directly reduce their diabetes-specific burden.
Conclusions
Although participants did mention that better glucose control was a goal, the common theme among the suggested features was lessening diabetes-related burdens. Understanding and targeting users' priorities to minimize physical and emotional burden will be crucial to enhance uptake and maintain use of future AP systems.
Comments
This qualitative study explores preferences for the holy grail of an ideal closed-loop system. It is unsurprising that the overwhelming desire of users and parents is simply to reduce burden. It has been well reported that diabetes devices provide benefits in terms of improved glycemic control and quality of life for many. They also create new burdens, which can include increased visibility of disease state, intrusion into daily living through alarms, fatigue with constant presence through wearing or carrying devices, skin irritations, and poor connectivity. Device size was cited as the most common burdensome feature; both youth and parents suggested smaller devices and fewer things to carry as beneficial. Devices with these features would be less intrusive in daily activities and more discreet. Greater automation of features, personalized algorithms, and upgrades were also reported as preferences that would reduce physical burden. Again, alarms remain a problem in terms of emotional burden, with suggestions for different tones for different events. The authors conclude that reducing physical burden, reducing mental effort, and making systems more discreet could be usefully addressed in future system designs in order to maximize uptake and maintain use.
Lived Experience of Advanced Hybrid Closed-Loop Versus Hybrid Closed-Loop: Patient-Reported Outcomes and Perspectives
Hood KK1, Laffel LM2, Danne T3, Nimri R4, Weinzimer SA5, Sibayan J6, Bailey RJ6, Schatz D7, Bratina N8, Bello R4, Punel A9, Calhoun P6, Beck RW6, Bergenstal RM9, Phillip M4,10 and on behalf of the FLAIR Study Group
1Departments of Pediatrics, Psychiatry and Behavioral Sciences, Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford, CA; 2Joslin Diabetes Center, Harvard Medical School, Boston, MA; 3Department of General Pediatrics and Endocrinology/Diabetology, Children's Hospital AUF DER BULT, Hannover, Germany; 4Jesse 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; 5Pediatric Endocrinology & Diabetes, Yale University, New Haven, CT; 6Jaeb Center for Health Research Foundation, Inc., Tampa, FL; 7Department of Pediatrics, University of Florida College of Medicine, Gainesville, FL; 8University Medical Center Ljubljana, University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; 9International Diabetes Center, HealthPartners Institute, Minneapolis, MN; 10Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Abstract
Background
This study reports on the lived experience of those using a Medtronic advanced hybrid closed-loop (AHCL) system compared to those using a first-generation hybrid closed-loop (HCL) system in a randomized, open-label, two-period crossover study.
Method
Patient-reported outcome (PRO) measures were conducted before randomization and at the end of each study period in 113 adolescents and young adults with type 1 diabetes.
Results
For AHCL, glucose monitoring satisfaction subscales for emotional burden and behavioral burden improved significantly (P < .01) over time with use of AHCL and co-occurred with glycemic improvements (reduced percent time above 180 mg/dL during the day and no change in percent time less than 54 mg/dL across 24 h) and greater time in Auto Mode; such changes were not seen with HCL. In several PRO measures, including distress, technology attitudes, and hypoglycemia confidence, no difference was found. AHCL use was correlated with better glucose monitoring satisfaction.
Conclusion
Satisfaction was higher in those participants who had more considerable glycemic benefit and stayed in Auto Mode more often.
Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial
Kudva YC1, Laffel LM2, Brown SA3,4, Raghinaru D5, Pinsker JE6, Ekhlaspour L7, Levy CJ8, Messer LH9, Kovatchev BP3, Lum JW5, Beck RW5, Gonder-Frederick L3; iDCL Trial Research Group
1Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN; 2Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston, MA; 3University of Virginia Center for Diabetes Technology, Charlottesville, VA; 4Division of Endocrinology, Department of Medicine, University of Virginia, Charlottesville, VA; 5Jaeb Center for Health Research, Tampa, FL; 6Sansum Diabetes Research Institute, Santa Barbara, CA; 7Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA; 8Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, NY; 9Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, CO
Background
Closed-loop control (CLC) has clearly demonstrated that its users have better glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. The authors have recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; the authors now report patient-reported outcomes (PROs) in this iDCL trial.
Methods
Participants were randomized 2:1 to the CLC (n=112) or SAP (n=56) group and filled out questionnaires, including the Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline and at 3 and 6 months. CLC participants also filed in Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS).
Results
The Hypoglycemia Fear Survey Behavior subscale score improved significantly after 6 months of CLC but not after 6 months of SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in the SAP group. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance scores did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores.
Conclusion
CLC improved some PROs when SAP did not. Participants reported high benefit and low burden with CLC.
Comments
Hood et al. report patient-reported outcomes (PROs) from a randomized, open-label, two-period crossover trial conducted at seven centers in the United States, Slovenia, Germany, and Israel. PRO assessments included diabetes distress, hypoglycemia confidence, glucose monitoring satisfaction, and technology attitudes. Results showed that advanced hybrid closed-loop systems improved satisfaction with glucose monitoring, with those experiencing greater glycemic improvements also reporting greater satisfaction. Diabetes distress did not change. Baseline hypoglycemia confidence and technology acceptance scores were already high, so ceiling effects could have masked any impact here, as most participants were already using technology prior to the study.
Kudva et al. similarly focus on the impact of closed-loop control on the lived experience of participants in terms of impact on psychosocial functioning and quality of life. They rightly state that any system cannot negatively impact quality of life for users. A range of PROs were assessed in the study with mixed results similar to those reported by Hood et al. What is clear is that there are clear benefits in terms of confidence managing hypoglycemia and positive expectations/experiences of the devices. However, it must be remembered that technologies themselves remain only part of the solution in reducing the impact of diabetes more broadly on people's lived experience.
As systems become more advanced, there is an opportunity to move beyond the purely physical medical model of health care toward a greater focus on psychosocial functioning and quality of life. Such an approach will be required to ensure that users are able to maximize the benefit of the systems while reducing the associated hassles. Ultimately, the goal is to minimize the negative impacts of diabetes on an individual's lived experience.
Footnotes
Author Disclosure Statement
No competing financial interests exist.