Real world hybrid closed‐loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months

Abstract

Objective: To describe predictors of hybrid closed loop (HCL) discontinuation and perceived barriers to use in youth with type 1 diabetes.Subjects: Youth with type 1 diabetes (eligible age 2-25 y; recruited age 8-25 y) who initiated the Minimed 670G HCL system were followed prospectively for 6 mo in an observational study.Research Design and Methods: Demographic, glycemic (time-in-range, HbA1c), and psychosocial variables [Hypoglycemia Fear Survey (HFS); Problem Areas in Diabetes (PAID)] were collected for all participants. Participants who discontinued HCL (<10% HCL use at clinical visit) completed a questionnaire on perceived barriers to HCL use.Results: Ninety-two youth (15.7 ± 3.6 y, HbA1c 8.8 ± 1.3%, 50% female) initiated HCL, and 28 (30%) discontinued HCL, with the majority (64%) discontinuing between 3 and 6 mo after HCL start. Baseline HbA1c predicted discontinuation (P = .026) with the odds of discontinuing 2.7 times higher (95% CI: 1.123, 6.283) for each 1% increase in baseline HbA1c. Youth who discontinued HCL rated difficulty with calibrations, number of alarms, and too much time needed to make the system work as the most problematic aspects of HCL. Qualitatively derived themes included technological difficulties (error alerts, not working correctly), too much work (calibrations, fingersticks), alarms, disappointment in glycemic control, and expense (cited by parents).Conclusions: Youth with higher HbA1c are at greater risk for discontinuing HCL than youth with lower HbA1c, and should be the target of new interventions to support device use. The primary reasons for discontinuing HCL relate to the workload required to use HCL. K E Y W O R D Sartificial pancreas, continuous glucose monitor, insulin pump, hybrid closed loop, pediatrics, type 1 diabetes Type 1 diabetes (T1D), typically diagnosed in childhood 1,2 requires lifelong replacement of exogenous insulin, and monitoring of glucose levels to minimize hypoglycemia and hyperglycemia. 3 Long-term consequences of suboptimal glycemic control include both microvascular and macrovascular complications that increase morbidity and mortality for individuals with T1D. 3 Sub-optimal glycemic control also increases risk of emergent complications such as hypoglycemic seizures and loss of consciousness, and diabetic ketoacidosis or diabetic coma. 4,5 The T1D Exchange Registry recently showed that in the United States only 21% of adults and 17% of youth with T1D meet hemoglobin A1c (HbA1c) goals set forth by the American Diabetes Association, signifying the need for improvements in treatment and care of T1D. 6

Six months of hybrid closed loop in the real‐world: An evaluation of children and young adults using the 670G system

“…The most common reasons for HCL discontinuation in our sample was difficulty with sensor calibration and perceived high workload required to maintain HCL. Analysis of reasons for HCL discontinuation in our sample of youth is published in a separate manuscript by Messer et al (in press) . These data suggest that the benefits in glycemic control with use of the HCL system may be hindered by difficulties maintaining use of CGM and sustaining time in Auto Mode.…”

“…Grando and colleagues published a pilot user experience survey among 21 adults using the 670G in Auto Mode, which similarly highlighted difficulties using the system . Although the participants in this study were satisfied with improvements in glucose control using Auto Mode, they also reported frustrations with the frequency of user inputs required to operate Auto Mode (ie, checking and entering a BG into the pump), and alert frequency . The youth in this real‐world study experienced nearly one Auto Mode exit per day, calibrated their sensor 2‐3 times per day, and checked blood glucose levels 5‐6 times per day.…”

“…Additionally, HCL discontinuation was high, and the reasons for HCL discontinuation were not collected as part of this study. Analysis of reasons for HCL discontinuation in a sub‐set of youth in this study who discontinued HCL is published in a separate manuscript by Messer et al (in press) . A treatment satisfaction questionnaire may have provided more insight into understanding reasons for discontinuation.…”

One-year experience of hybrid closed-loop system in children and adolescents with type 1 diabetes previously treated with multiple daily injections: drivers to successful outcomes

“…It remains to be determined whether these short-term effects on improved glycemic control with HCL systems are maintained in the long-term period. Long-term effect (6 and 12 months) of HCL shows scarce results in terms of Auto Mode usage, sensor wear, HbA1c, time in the target range and pump discontinuation [13][14][15][16]. The objective of this study was to evaluate the effect of a 1-year HCL system on glycemic control in children and adolescents with T1D previously treated with MDI.…”

New and Emerging Technologies in Type 1 Diabetes

“…Another real-world cohort study of 79 pediatric and adult patients reported that 33% discontinued auto mode use within 12 months. 33 , 34 Reasons cited included the number of alarms, challenges with requiring calibrations, and dissatisfaction with glycemic control. 34 …”