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

Weissberg‐Benchell, Jill; Shapiro, Jenna B.; Hood, Korey K.; Laffel, Lori M.; Naranjo, Diana; Miller, Kellee M.; Barnard, Katharine

doi:10.1111/dme.13930

Cited by 64 publications

(40 citation statements)

References 30 publications

(47 reference statements)

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“…Diabetes distress, for example, has been shown previously to be associated with poorer T1D self‐management practices and glycemic control in youth with T1D, and should be further considered in light of the workload and alert fatigue described by HCL discontinuers. Other psychological factors may yield further insight into discontinuation of HCL, including self‐efficacy for diabetes care, or perceptions and expectations of HCL systems . Fear of hypoglycemia, while important to overall glycemic control, may not be the most likely indicator for understanding who will discontinue HCL.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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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

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Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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“…28 Thus, we recommend that health professionals regularly assess users of closed-loop systems, particularly adolescents, in line with existing clinical practice for the psychological support of people with type 1 diabetes. Furthermore, integrating validated psychological tools such as INSPIRE 29 into users' initial teaching package could help clarify their expectations, anxieties, and hopes regarding closedloop systems and highlight issues that may need to be addressed to ensure safe and effective long-term use of this technology.…”

Section: Discussionmentioning

confidence: 99%

What Training, Support, and Resourcing Do Health Professionals Need to Support People Using a Closed-Loop System? A Qualitative Interview Study with Health Professionals Involved in the Closed Loop from Onset in Type 1 Diabetes (CLOuD) Trial

Kimbell

Rankin

Ashcroft

et al. 2020

Diabetes Technology & Therapeutics

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Background: We explored health professionals' views about the training, support, and resourcing needed to support people using closed-loop technology in routine clinical care to help inform the development of formal guidance. Methods: Interviews were conducted with health professionals (n = 22) delivering the Closed Loop from Onset in Type 1 Diabetes (CLOuD) trial after they had ‡6 months' experience of supporting participants using a closed-loop system. Data were analyzed descriptively. Results: Interviewees described how, compared with other insulin regimens, teaching and supporting individuals to use a closed-loop system could be initially more time-consuming. However, they also noted that after an initial adjustment period, users had less need for initiating contact with the clinical team compared with people using pumps or multiple daily injections. Interviewees highlighted how a lessened need for ad hoc clinical input could result in new challenges; specifically, they had fewer opportunities to reinforce users' diabetes knowledge and skills and detect potential psychosocial problems. They also observed heightened anxiety among some parents due to the constant availability of data and unrealistic expectations about the system's capabilities. Interviewees noted that all local diabetes teams should be empowered to deliver closed-loop system care, but stressed that

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“…In a number of studies, diabetes burn‐out has been associated with suboptimal adherence to IP therapy and, furthermore, may be connected to anxiety and depression. Indeed, more research must be conducted to establish a deeper understanding of objective adherence behaviours in relation to technology such as insulin pumps …”

Section: Introductionmentioning

confidence: 99%

Factors associated with withdrawal from insulin pump therapy: A large‐population‐based study

Merzon

Grossman

Vinker

et al. 2020

Diabetes Metabolism Res

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Background: Although, number of diabetic patients received insulin pump (IP) therapy is increasing; there are limited data regarding factors associated with IP withdrawal.Methods: We conducted a cross-sectional study using data from an Israeli health maintenance organization. All patients, 21 or older, with type 1 (T1DM) or type 2 (T2DM) diabetes, who received IP therapy for a 7-year period were identified.Patients who did not purchase IP maintenance supplies for at least six consecutive months were defined as withdrawn (N = 355). Patients who purchased supplies were defined as adherent (N = 352). Results: In both T1DM and T2DM patients, withdrawal from IP therapy was positively associated with duration of diabetes longer than 5 years (odds ratio [OR] = 13.26 [CI, 7.16-23.34; P < .001] and OR = 10.92 [CI, 5.64-21.14; P < .001], respectively), nonadherence to dietician follow-up (OR = 5.78 [CI, 3.65-9.14; P < .001] and OR = 3.41 [CI, 1.99-5.85; P < .001], respectively), and poor glycaemic control prior to IP treatment (OR = 4.04 [CI, 2.18-7.48; P < .001] and OR = 4.59 [CI, 2.71-7.81; P < .001], respectively]. Co-morbid neuro-psychiatric disorders were also risk factors for IP withdrawal: diagnosis of depression (OR = 2.22 [CI, 1.16-4.27; P = .017] and Attention Deficit Hyperactivity Disorder (ADHD) OR = 2.45 [CI, 1.003-5.087; P = .043]) among T1DM patients; and diagnosis of depression (OR = 1.85 [CI, 1.05-5.27; P = .046] and dementia OR = 4.03 [CI, 1.03-19.77; P = .048]) among T2DM patients. Conclusion: In our large real-world population-based study, we found that smoking, obesity, poor glycaemic control, and co-morbid neuro-psychiatric disorders were associated with a high rate of withdrawal from IP therapy. Health care providers ought to familiarize themselves with patient characteristics predictive of nonadherence and should intensify patient follow-up when incorporating this new, costly, and challenging technology. K E Y W O R D S diabetes mellitus, insulin pump, nonadherence

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

Cited by 64 publications

References 30 publications

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

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

What Training, Support, and Resourcing Do Health Professionals Need to Support People Using a Closed-Loop System? A Qualitative Interview Study with Health Professionals Involved in the Closed Loop from Onset in Type 1 Diabetes (CLOuD) Trial

Factors associated with withdrawal from insulin pump therapy: A large‐population‐based study

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