Expanding the use of patient-reported outcomes (PROs): Screening youth with type 1 diabetes from underrepresented populations.

AIM: Youth from lower socioeconomic status (SES) have suboptimal type 1 diabetes (T1D) outcomes. Patient reported outcomes (PROs) measure psychosocial states and are associated with T1D outcomes, however are understudied in low SES youth. We aimed to evaluate associations between PROs and public insurance status, a proxy for low SES. METHODS: We analyzed survey data from 129 youth with T1D (age 15.7 ± 2.3 years, 33 % publicly insured) screened with PROMIS Global Health (PGH, measuring global health) and Patient Health Questionnaire (PHQ-9, measuring depressive symptoms) during diabetes appointments. Correlation and regression analyses evaluated differences in PGH and PHQ-9 by insurance status. RESULTS: For youth with public insurance, lower global health correlated with lower self-monitoring blood glucose (SMBG; r = 0.38,p = 0.033) and older age (r = -0.45,p = 0.005). In youth with private insurance, lower global health correlated with lower SMBG (r = 0.27,p = 0.018) and female sex (rho = 0.26,p = 0.015). For youth with private insurance, higher depressive symptoms correlated with higher body mass index (r = 0.22,p = 0.03) and fewer SMBG (r = -0.35,p = 0.04). In multivariate regression analyses, public insurance was inversely associated with global health (p = 0.027). CONCLUSION: PGH is a particularly salient PRO in youth with public insurance. Global health may be an important psychosocial factor to assess in youth with T1D from low SES backgrounds.

Qualitative Study of User Experiences with Loop, an Open-Source Automated Insulin Delivery System.

Background: Loop is an open-source automated insulin delivery (AID) system, used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation. Methods: Focus groups revealed 72 new and existing users' perspectives on Loop uptake, use, and persistence. A subsample of participants from a mixed-methods, observational cohort study shared first-hand accounts of their experiences using Loop. Participants were predominately white (95%), male (50%), privately insured (94%), and reported annual household income ≥$100K (73%) and education exceeding a bachelor's degree (87%) with a mean HbA1c of 6.6% ± 0.8%. Data were analyzed and synthesized by a multidisciplinary team. Results: Participants detailed their experiences with (1) Loop technical support and troubleshooting, (2) decreased mental/behavioral burden, (3) technical issues with parts of the system, (4) glycemic control, (5) personalizing settings, and (6) providers while using Loop. Decreased burden was the most endorsed benefit defined by less worry, stress, and cognitive effort and less time spent on diabetes management tasks. Participants highlighted the benefits of Loop overnight and their introduction to "Loop communities" during use. The most discussed challenges involved technical issues. A range of provider attitudes and knowledge about Loop complicated users' clinical experiences and disclosure. Conclusions: This sample of new and experienced Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components, customizing the system to suit one's lifestyle and habits, and adjusting system settings. Challenges related to system setup and calibrating settings are remediable and, if addressed, may better serve Loop users. Users reported feeling empowered by the customizability of and the educational effects facilitated by the open-source AID system. Loop helped users learn more about their chronic illness and physiology in an acceptable format. Clinical Trial Registration number: NCT03838900.

Discontinued Use of the Loop Insulin Dosing System: A Mixed-Methods Investigation.

Background: Loop is an open-source automated insulin dosing system that allows users unrivaled control over system settings that affect future glucose prediction. Thousands use Loop, but little is known about those who discontinue. Methods: In a large observational study, 874 Loop participants completed surveys and provided glycemic data, 46 (5.3%) of those self-identified as discontinuing Loop use during the observation window, 45 completed a discontinued use survey, 22 provided system settings data, and 19 participated in semistructured interviews about their discontinuation. Qualitative data were transcribed, coded, and analyzed. Results: Older age and not trusting Loop were associated with discontinued use, although no other demographic or clinical characteristics were significant correlates. The most endorsed reasons were "I decided to try something else" (27.8%) followed by "It just didn't help as much as I thought it would" (22.2%). Qualitative analyses revealed prominent themes centered upon mental and emotional burden and adjusting settings. Other reasons for discontinued use included fear of disapproval of Loop use from diabetes provider, barriers to acquiring component devices, a desire to try new/different technologies, concerns that Loop could not accommodate specific exercise or low insulin dose regimens, and worry about Loop use during pregnancy. It was noted that burdens might be alleviated by enhanced technical assistance and expert guidance. Conclusions: Although the majority of individuals in the Loop observational study continued use, those who discontinued reported similar challenges. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Clinical Trial Registration: clinicaltrials.gov (NCT03838900).

Cost considerations for adoption of diabetes technology are pervasive: A qualitative study of persons living with type 1 diabetes and their families.

BACKGROUND: Cost is a major consideration in the uptake and continued use of diabetes technology. With increasing use of automated insulin delivery systems, it is important to understand the specific cost-related barriers to technology adoption. In this qualitative analysis, we were interested in understanding and examining the decision-making process around cost and diabetes technology use. MATERIALS AND METHODS: Four raters coded transcripts of four stakeholder groups using inductive coding for each stakeholder group to establish relevant themes/nodes. We applied the Social Ecological Model in the interpretation of five thematic levels of cost. RESULTS: We identified five thematic levels of cost: policy, organizational, insurance, interpersonal and individual. Equitable diabetes technology access was an important policy-level theme. The insurance-level theme had multiple subthemes which predominantly carried a negative valence. Participants also emphasized the psychosocial burden of cost specifically identifying diabetes costs to their families, the guilt of diabetes related costs, and frustration in the time and involvement required to ensure insurance coverage. CONCLUSION: We found broad consensus in how cost is experienced by stakeholder groups. Cost considerations for diabetes technology uptake extended beyond finances to include time, cost to society, morality and interpersonal relationships. Cost also reflected an important moral principle tied to the shared desire for equitable access to diabetes technology. Knowledge of these considerations can help clinicians and researchers promote equitable device uptake while anticipating barriers for all persons living with type 1 diabetes and their families.

Do Youth Want Psychosocial Screenings in Diabetes Clinic? Profiles of Acceptability.

AIMS: Psychosocial screenings are recommended and increasingly common in pediatric subspecialty clinics, though little is known about their acceptability. This study seeks to uncover profiles of acceptability and assess demographic and clinical correlates among adolescents with diabetes. METHODS: A sample of 124 adolescents (57.7% female) ages 12-21 years (M = 16.2 ± 2.3) completed screenings during routine diabetes appointments. K-means clustering of responses to acceptability items derived profiles; Analysis of Variance (ANOVA) and Chi-square tests assessed correlates. RESULTS: Adolescents with the most common profile (72.6%) placed high importance on medical providers' awareness of their emotions and reported no difficulties/discomfort with the screener. These youth had moderate depressive symptoms, low diabetes distress, and low A1c. Those who fit a less common profile (18.5%) were uncomfortable with the screener and had the highest depressive symptoms and lowest A1c. Youth who fit a smaller profile (6.5%) endorsed technical difficulties and had high depressive symptoms and lowest diabetes distress. The smallest profile (2.4%, N = 3) had difficulty understanding and experienced discomfort with the screening and had the lowest depressive symptoms and the highest diabetes distress and A1c. These differences in depressive symptoms (F = 3.54, p = .017), A1c values (F = 4.03, p = .009), and diabetes distress (F = 3.27, p = .036) were significant though differences in age, gender, and diabetes duration were not. CONCLUSIONS: Most youth responded favorably to in-clinic psychosocial screenings. Youth who were less satisfied were at increased risk for psychosocial and medical complications. Findings highlight areas of need, such as enhanced support with and an emphasized rationale for screenings, which may improve patient experience in subspecialty care.

Barriers to Continuous Glucose Monitoring in People With Type 1 Diabetes: Clinician Perspectives.

The purpose of this study was to determine clinician attitudes about the distinct barriers to uptake of continuous glucose monitoring (CGM) among people with diabetes. Survey data were collected measuring individual barriers, prerequisites to CGM, confidence in addressing barriers, and clinic staff resources. Results show that clinicians commonly report barriers to using CGM among people with diabetes in their clinic. Furthermore, clinicians who report a high number of barriers do not feel confident in overcoming the barriers to CGM. Interventions that attempt to empower clinicians to address concerns about CGM among people with diabetes may be warranted because low uptake does not appear to be directly related to available resources or prerequisites to starting CGM.

Exposure to Closed Loop Barriers Using Virtual Reality.

BACKGROUND: Closed loop (CL) automated insulin delivery systems are demonstrated to be safe and effective in regulating glucose levels and reducing cognitive burden in people with type 1 diabetes (T1D). However, given the limited market options and the do-it-yourself nature of most systems, it can be difficult for potential users to shape their expectations fitting them into daily lives and management routines. As such, we examined the potential feasibility of a virtual reality (VR) intervention. METHODS: A four-part VR intervention was created to expose adults with T1D to expected CL system barriers: body image, perceived hassles of using CL, deskilling fears, and unwanted social attention. Goals of the pilot were to assess feasibility and expose patients to CL. Surveys were conducted pre- and postparticipating in the VR experience. RESULTS: A total of 20 adults with T1D completed the pilot. Average time to complete the experience was 14.1 minutes (8.8-39.9). Reported VR sickness was low. Willingness to use VR was maintained in 90% (n = 18) and did not change expectations of CL in 95% (n = 19). Virtual reality changed perceived hassles of CL in 25% (n = 5) with four concerned over alarms and one connectivity issues: positive diabetes technology attitudes, confidence in managing hypoglycemia, overall perceptions of appearance, and positive affect maintained after the VR intervention. Negative affect significantly decreased after exposure and perceptions of being overweight trended toward significance. CONCLUSION: This pilot VR intervention demonstrated high potential in addressing expected barriers to uptake and usage of CL systems without decreasing enthusiasm or changing expectations of CL.

Parental Perspectives: Identifying Profiles of Parental Attitudes and Barriers Related to Diabetes Device Use.

Background: Despite the demonstrated benefits of diabetes device use, uptake of insulin pumps and continuous glucose monitors (CGMs) remains quite low. The current study aimed to identify profiles of parents of youth with type 1 diabetes based on their attitudes toward diabetes-specific technology and barriers to diabetes technology uptake. Methods: Online survey data were collected from 471 parents in the T1D Exchange Clinic Network (child's age = 12.0 ± 3.2 years; diabetes duration = 7.0 ± 2.9 years; A1c = 8.4% ± 1.3; 75% using insulin pump; 27% using CGM). Results: K-means cluster analyses revealed five parent profiles: Embracers (50.7%), Burdened (15.7%), Hopeful but Hassled (14.2%), Distrusting (12.7%), and Data Minimalists (6.6%). ANOVAs and chi-square tests identified differences between groups based on diabetes distress, worry over hypoglycemia, device use, and demographic characteristics. Conclusions: Providers encouraging device uptake may benefit from tailoring their approaches based on these distinct groups and their corresponding concerns and needs.

Depression in context: Important considerations for youth with type 1 vs type 2 diabetes.

BACKGROUND: Youth with diabetes are at increased risk for depression. However, severity and correlates of depressive symptoms may differ by diabetes type. OBJECTIVE: Associations of depressive symptoms with global health, diabetes duration, and gender were compared between youth with type 1 and type 2 diabetes. METHODS: A sample of 149 youth ages 12 to 21 diagnosed with either type 1 (n = 122) or type 2 (n = 27) diabetes were screened during routine clinic appointments. Regression models were constructed to examine differences by diabetes type. RESULTS: Adolescents with type 2 diabetes had significantly higher depressive symptom scores (4.89 vs 2.99, P = .025) than those with type 1 diabetes. A significant interaction between global health and diabetes type on depressive symptoms revealed inverse associations between global health and depressive symptoms that was stronger among youth with type 2 diabetes (ß = -.98, P < .001) than type 1 (ß = -.48, P < .001). Further probing revealed that among youth with better global health, adolescents with type 1 had more depressive symptoms than those with type 2 diabetes (ß = .33, P = .035). Diabetes duration and depressive symptoms were positively associated among individuals with type 2 (ß = .86, P = .043), but not type 1 diabetes. No gender differences were detected. CONCLUSION: These findings suggest that correlates of depressive symptoms in youth with diabetes differ by diabetes type. Global health appears to be an important correlate among youth with both types, whereas diabetes duration was only a significant factor among those with type 2 diabetes. The current findings can inform future psychosocial intervention efforts within both these populations.

Using Cluster Analysis to Understand Clinician Readiness to Promote Continuous Glucose Monitoring Adoption.

BACKGROUND: Many people with type 1 diabetes (T1D) report barriers to using continuous glucose monitoring (CGM). Diabetes care providers may have their own barriers to promoting CGM uptake. The goal of this study was to develop clinician "personas" with regard to readiness to promote CGM uptake. METHODS: Diabetes care providers who treat people with T1D (N = 209) completed a survey on perceived patient barriers to device uptake, technology attitudes, and characteristics and barriers specific to their clinical practice. K-means cluster analyses grouped the sample by CGM barriers and attitudes. ANOVAs and chi-square tests assessed group differences on provider and patient characteristics. The authors assigned descriptive names for each persona. RESULTS: Analyses yielded three clinician personas regarding readiness to promote CGM uptake. Ready clinicians (20% of sample; 24% physicians, 38% certified diabetes educators/CDEs) had positive technology attitudes, had clinic time to work with patients using CGM, and found it easy to keep up with technology advances. In comparison, Cautious clinicians (41% of sample; 17% physicians, 53% CDEs) perceived that their patients had many barriers to adopting CGM and had less time than the Ready group to work with patients using CGM data. Not Yet Ready clinicians (40% of sample; 9% physicians; 79% CDEs) had negative technology attitudes and the least clinic time to work with CGM data. They found it difficult to keep up with technology advances. CONCLUSION: Some diabetes clinicians may benefit from tailored interventions and additional time and resources to empower them to help facilitate increased uptake of CGM technology.

Hypoglycemia in sulfonylurea-treated KCNJ11-neonatal diabetes: Mild-moderate symptomatic episodes occur infrequently but none involving unconsciousness or seizures.

BACKGROUND: Neonatal diabetes mellitus (NDM) caused by mutations in KCNJ11 can be successfully treated with high dose oral sulfonylureas; however, little data is available on the risk of hypoglycemia. OBJECTIVE: To determine the frequency, severity, and clinical significance of hypoglycemia in KCNJ11-related NDM. METHODS: Utilizing the University of Chicago Monogenic Diabetes Registry, parents completed an online questionnaire addressing hypoglycemia. Continuous glucose monitoring (CGM) data was available for 7 subjects. RESULTS: Thirty subjects with KCNJ11-related permanent NDM (166 patient-years on sulfonylurea) had median sulfonylurea dose of 0.39 mg/kg/day (0.24-0.88 IQR, interquartile range) with median HbA1c 5.7% (39 mmol/mol) (5.5-6.1 IQR, 37-43 mmol/mol). Hypoglycemia (<70 mg/dL) was reported monthly once or less frequently in 89.3% of individuals, but 3 (10.7%) reported once weekly or more. Of all hypoglycemic episodes reported, none involved seizures or unconsciousness and thus did not meet the current ISPAD definition of severe hypoglycemia. Seven individuals wore a CGM for a total of 912 hours with blood sugars falling below 70 mg/dL for 5.8% of the time recorded, similar to ranges reported for people without diabetes. CONCLUSIONS: In our cohort of KCNJ11-related permanent NDM, hypoglycemia is infrequent and mild despite the high doses of sulfonylurea used and near-normal level of glycemic control. Long-term follow-up on larger numbers will be required to clarify the incidence and determinants of hypoglycemia in this unique population.

ADHD, learning difficulties and sleep disturbances associated with KCNJ11-related neonatal diabetes.

OBJECTIVES: Mutations in KCNJ11 are the most common cause of permanent neonatal diabetes mellitus (NDM). Approximately 25% of patients have obvious neurological dysfunction, but whether milder related problems might be more common has been unclear. We sought to assess the prevalence of parental concerns about learning, behavior, attention deficit hyperactivity disorder (ADHD), social competency, and sleep in subjects with KCNJ11-related NDM compared to unaffected sibling controls. STUDY DESIGN: Subjects or their guardians in the University of Chicago Monogenic Diabetes Registry completed a survey examining learning, behavior, ADHD and sleep. Thirty subjects with KCNJ11 -related NDM and 25 unaffected sibling controls were assessed. Data were analyzed using GraphPad Prism 6. Nonparametric analysis was performed using Fisher's exact test for group comparisons. RESULTS: Thirteen (43%) individuals with KCNJ11 -related NDM had treatment for or a diagnosis of ADHD compared to two (8%) of the sibling controls (P < 0.05). Compared to their sibling controls, individuals with KCNJ11 mutations had significant differences in behavior difficulties, social awareness, academic achievement and the need for an Individualized Education Plan (IEP). As seen in other neurodevelopmental disorders, individuals with KCNJ11 mutations also had significantly higher rates of sleep difficulties (P < 0.01). CONCLUSION: Patients with KCNJ11 -related NDM are at an increased risk for delays in learning, social-emotional and behavioral development, ADHD and sleep difficulties based on parent report. Early identification, along with integrated medical and developmental support, may promote better neurodevelopmental outcomes for this unique population. Further investigation utilizing detailed neuropsychological testing will better define the neurodevelopmental consequences of KATP mutations.