Closing the Loop in Adults, Children and Adolescents With Suboptimally Controlled Type 1 Diabetes Under Free Living Conditions: A Psychosocial Substudy

Barnard, Katharine; Wysocki, Timothy; Ully, Vanessa; Mader, Julia K.; Pieber, Thomas R.; Thabit, Hood; Tauschmann, Martin; Leelarathna, Lalantha; Hartnell, Sara; Acerini, Carlo L.; Wilinska, Malgorzata E.; Dellweg, Sibylle; Benesch, Carsten; Arnolds, Sabine; Holzer, Manuel; Kojzar, Harald; Campbell, Fiona; Yong, James; Pichierri, Jennifer; Hindmarsh, Peter C.; Heinemann, Lutz; Evans, Mark L.; Hovorka, Roman

doi:10.1177/1932296817702656

Cited by 105 publications

(148 citation statements)

References 11 publications

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“…As childhood is a time of both physical and mental development, a system that can adjust insulin delivery in real time based on sensor glucose readings will more closely mimic normal physiology than what can be achieved with quarterly health care visits. Furthermore, as described by participants in HCL studies, waking with fasting glucose levels close to target range may allow for better sleep and an improved start to the day (20), a finding that has been corroborated by youth and their parents (19). As Sir William Osler said, "The good physician treats the disease, the great physician treats the patient who has the disease."…”

Section: Discussionmentioning

confidence: 93%

“…Moreover, patients and parents may benefit from improved sleep patterns, as the need for intermittent overnight blood glucose meter measurements and sensor alarms will be minimized. Indeed, improved sleep has been endorsed by participants in studies of HCL insulin delivery that assessed the psychosocial impact of system use (17)(18)(19)(20).…”

Section: Benefits Of Hcl Control In Pediatricsmentioning

confidence: 99%

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Closing the Loop on Managing Youth With Type 1 Diabetes: Children Are Not Just Small Adults

Sherr

2018

Diabetes Care

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As hybrid closed-loop (HCL) insulin delivery systems permeate clinical practice, it is critical to ensure all with diabetes are afforded the opportunity to benefit from this technology. Indeed, due to the suboptimal control achieved by the vast majority of youth with type 1 diabetes (T1D), pediatric patients are positioned to see the greatest benefit from automated insulin delivery systems. To ensure these systems are well poised to deliver the promise of more targeted control, it is essential to understand the unique characteristics and factors of childhood. Herein, the developmental and physiological needs ofyouth with T1Dare reviewed and consideration is given to how HCL could address these issues. Studies of HCL technologies in youth are briefly reviewed. As future-generation closed-loop systems are being devised, features that could make this technology more attractive to youth and to their families are discussed. Integration of HCL has the potential to minimize the burden of this chronic medical condition while improving glycemic control and ultimately allowing our pediatric patients to fulfill the primary goal of childhood, to be a kid."Children are not small adults" is a phrase that every pediatric practitioner becomes well aware of during training. Indeed, the developmental changes that are the hallmark of this stage of life will never be recapitulated. In growing children with type 1 diabetes (T1D), the burden of having to constantly adjust insulin needs is a neverending challenge, especially when growth and development accelerate during puberty. It is not surprising that the summit of suboptimal control of T1D is observed in adolescence (1). Pivotal trials of new drugs and technologies for diabetes are typically carried out first in adults, not only to avoid unnecessary exposure of children to unexpected adverse effects of new therapies but also because near-optimal control of T1D is much more common in adults than in children and adolescents. Thus, it is of utmost importance to consider factors that require special attention during childhood.In our youngest patients, the inability to communicate needs may lead caregivers to adopt a strategy of constant vigilance (2). Despite such vigilance, it was reported that 90% of hypoglycemic events detected by blinded continuous glucose monitoring (CGM) in infants and toddlers occurred without concomitant symptoms of hypoglycemia detected by their caregivers (3). Due to unpredictable changes in appetite and food intake, many families of young children administer meal boluses after instead of before eating, even at the expense of greater postprandial hyperglycemia and the suboptimal glycemic control that this approach is associated with (4). Nighttime is often the worst time for parents of young children with diabetes due to fears about hypoglycemia, which leads to disturbed sleep patterns secondary to the need to monitor overnight blood glucose levels two or more times per night (5,6).School-aged children are in the care of numerous adults throughout the day: p...

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Section: Discussionmentioning

confidence: 93%

Section: Benefits Of Hcl Control In Pediatricsmentioning

confidence: 99%

Closing the Loop on Managing Youth With Type 1 Diabetes: Children Are Not Just Small Adults

Sherr

2018

Diabetes Care

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“…Benefits include improved daytime [6] and night-time [6,7] glycaemic control, and psychosocial benefits of reduced worry [6] and burden [8,9], decreased fear of hypoglycaemia [9], decreased diabetes distress [8], improved sleep [6], increased treatment satisfaction [8], improved well-being [7], and trust in the system [5,8]. Benefits include improved daytime [6] and night-time [6,7] glycaemic control, and psychosocial benefits of reduced worry [6] and burden [8,9], decreased fear of hypoglycaemia [9], decreased diabetes distress [8], improved sleep [6], increased treatment satisfaction [8], improved well-being [7], and trust in the system [5,8].…”

Section: Introductionmentioning

confidence: 99%

Assessing patient‐reported outcomes for automated insulin delivery systems: the psychometric properties of the INSPIRE measures

et al. 2019

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Aim Participants in clinical trials assessing automated insulin delivery systems report perceived benefits and burdens that reflect their experiences and may predict their likelihood of uptake and continued use of this novel technology. Despite the importance of understanding their perspectives, there are no available validated and reliable measures assessing the psychosocial aspects of automated insulin delivery systems. The present study assesses the initial psychometric properties of the INSPIRE measures, which were developed for youth and adults with Type 1 diabetes, as well as parents and partners. Methods Data from 292 youth, 159 adults, 150 parents of youth and 149 partners of individuals recruited from the Type 1 Diabetes Exchange Registry were analysed. Participants completed INSPIRE questionnaires and measures of quality of life, fear of hypoglycaemia, diabetes distress, glucose monitoring satisfaction. Exploratory factor analysis assessed factor structures. Associations between INSPIRE scores and other measures, HbA1c, and technology use assessed concurrent and discriminant validity. Results Youth, adult, parent and partner measures assess positive expectancies of automated insulin delivery systems. Measures range from 17 to 22 items and are reliable (α = 0.95–0.97). Youth, adult and parent measures are unidimensional; the partner measure has a two‐factor structure (perceptions of impact on partners versus the person with diabetes). Measures showed concurrent and discriminant validity. Conclusions INSPIRE measures assessing the positive expectancies of automated insulin delivery systems for youth, adults, parents and partners have meaningful factor structures and are internally consistent. The developmentally sensitive INSPIRE measures offer added value as clinical trials test newer systems, systems become commercially available and clinicians initiate using these systems.

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“…In quantitative and qualitative psychosocial analyses of experiences of home trial participants, pediatric and adolescent users of overnight closed-loop and their parents reported benefits including reassurance/peace of mind, having ‘time-off’ from managing their diabetes, improved overnight control leading to improved daily functioning and diabetes control, and improved sleep [60,61]. The key negative themes related mainly to technical issues such as device connectivity and sensor calibration, intrusiveness of alarms, and size of the devices.…”

Section: Glucose Responsive Suspension Of Insulin Deliverymentioning

confidence: 99%

“…The key negative themes related mainly to technical issues such as device connectivity and sensor calibration, intrusiveness of alarms, and size of the devices. Overall, children and adolescents reported a positive experience of the closed-loop technology with perceived benefits of a closed-loop system outweighing practical challenges [60,61]. …”

Section: Glucose Responsive Suspension Of Insulin Deliverymentioning

confidence: 99%

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

Tauschmann

Hovorka

2017

Expert Opinion on Drug Delivery

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Introduction: Nocturnal glucose control remains challenging in children and adolescents with type 1 diabetes due to highly variable overnight insulin requirements. The issue may be addressed by glucose responsive insulin delivery based on real-time continuous glucose measurements.Areas covered: This review outlines recent developments of glucose responsive insulin delivery systems from a paediatric perspective. We cover threshold-based suspend application, predictive low glucose suspend, and more advanced single hormone and dual-hormone closed-loop systems. Approaches are evaluated in relation to nocturnal glucose control particularly during outpatient randomised controlled trials.Expert opinion: Significant progress translating research from controlled clinical centre settings to free-living unsupervised home studies have been achieved over the past decade. Nocturnal glycaemic control can be improved whilst reducing the risk of hypoglycaemia with closed-loop systems. Following the US regulatory approval of the first hybrid closed-loop system in non-paediatric population, large multinational closed-loop clinical trials and pivotal studies including paediatric populations are underway or in preparation to facilitate the use of closed-loop systems in clinical practice.

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Closing the Loop in Adults, Children and Adolescents With Suboptimally Controlled Type 1 Diabetes Under Free Living Conditions: A Psychosocial Substudy

Abstract: Overall, participants reported a positive experience of the closed loop technology. Results are consistent with previous research with size of equipment continuing to be a problem. Progress is being made in the usability of the closed-loop system.

Cited by 105 publications

References 11 publications

Closing the Loop on Managing Youth With Type 1 Diabetes: Children Are Not Just Small Adults

Closing the Loop on Managing Youth With Type 1 Diabetes: Children Are Not Just Small Adults

Assessing patient‐reported outcomes for automated insulin delivery systems: the psychometric properties of the INSPIRE measures

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

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