Cost, Hassle, and On-Body Experience: Barriers to Diabetes Device Use in Adolescents and Potential Intervention Targets.

Background: Adolescents with diabetes have the highest A1cs of all age groups. Diabetes devices (insulin pumps and continuous glucose monitors [CGM]) can improve glycemic outcomes, and although the uptake of devices has increased, they remain underutilized in this population. This study characterizes adolescent-reported barriers to diabetes device use to determine targets for clinician intervention. Methods: We surveyed 411 adolescents with type 1 diabetes (mean age 16.30 ± 2.25 years) on barriers to diabetes device use, technology use attitudes (general and diabetes specific), benefits and burdens of CGM, self-efficacy for diabetes care, diabetes distress, family conflict, and depression. We characterize barriers to device uptake; assess demographic and psychosocial differences in device users, discontinuers, and nonusers; and determine differences in device use by gender and age. Results: The majority of adolescents used an insulin pump (n = 307, 75%) and more than half used CGM (n = 225, 55%). Cost/insurance-related concerns were the most commonly endorsed barrier category (61%) followed by wear-related issues (58.6%), which include the hassle of wearing the device (38%) and dislike of device on the body (33%). Adolescents who endorsed more barriers also reported more diabetes distress (P = 0.003), family conflict (P = 0.003), and depressive symptoms (P = 0.014). Pump and CGM discontinuers both endorsed more barriers and more negative perceptions of technology than current users, but reported no difference from device users in diabetes distress, family conflict, or depression. Gender was not related to the perceptions of devices. Conclusions: Clinicians can proactively assess attitudes toward diabetes technology and perceptions of benefits/burdens to encourage device uptake and potentially prevent device discontinuation among adolescents.

Suicide Risk Assessment in Youth and Young Adults With Type 1 Diabetes.

OBJECTIVE: To describe sociodemographic and clinical characteristics of youth and young adults with type 1 diabetes who endorsed suicidal ideations as part of routine depression screening and the results of their suicide risk assessments. RESEARCH DESIGN AND METHODS: The Patient Health Questionnaire-9 was used to assess depressive symptoms and suicide/death ideation in 550 youth and young adults with type 1 diabetes ages 10-24 years. Only individuals who endorsed suicidal/death ideations (n = 49) completed a standardized suicide risk assessment protocol and safety planning. RESULTS: Nine percent of individuals endorsed suicidal/death ideation and of those, 83.4% reported clinically elevated depressive symptoms; 16% made a previous suicide attempt. No youth (n = 39) or young adults (n = 11) disclosed current plans or preparations for suicide, but five who expressed suicidal ideation acknowledged the lethality of insulin for an attempt. Three previously used insulin to attempt suicide. The overwhelming majority of individuals were classified as being low risk for future suicide attempt/completion. None were hospitalized as a part of the suicide risk assessment, and no suicide completions have occurred. CONCLUSIONS: The findings of this study provide initial insight into the behaviors and cognitions of youth and young adults with type 1 diabetes who experience suicidal and death ideations. Comprehensive suicide risk assessment and safety planning are feasible during routine type 1 diabetes clinic appointments.

Assessment of a Precision Medicine Analysis of a Behavioral Counseling Strategy to Improve Adherence to Diabetes Self-management Among Youth: A Post Hoc Analysis of the FLEX Trial.

Importance: The Flexible Lifestyles Empowering Change (FLEX) trial, an 18-month randomized clinical trial testing an adaptive behavioral intervention in adolescents with type 1 diabetes, showed no overall treatment effect for its primary outcome, change in hemoglobin A1c (HbA1c) percentage of total hemoglobin, but demonstrated benefit for quality of life (QoL) as a prespecified secondary outcome. Objective: To apply a novel statistical method for post hoc analysis that derives an individualized treatment rule (ITR) to identify FLEX participants who may benefit from intervention based on changes in HbA1c percentage (primary outcome), QoL, and body mass index z score (BMIz) (secondary outcomes) during 18 months. Design, Setting, and Participants: This multisite clinical trial enrolled 258 adolescents aged 13 to 16 years with type 1 diabetes for 1 or more years, who had literacy in English, HbA1c percentage of total hemoglobin from 8.0% to 13.0%, a participating caregiver, and no other serious medical conditions. From January 5, 2014, to April 4, 2016, 258 adolescents were recruited. The post hoc analysis excluded adolescents missing outcome measures at 18 months (2 participants [0.8%]) or continuous glucose monitoring data at baseline (40 participants [15.5%]). Data were analyzed from April to December 2018. Interventions: The FLEX intervention included a behavioral counseling strategy that integrated motivational interviewing and problem-solving skills training to increase adherence to diabetes self-management. The control condition entailed usual diabetes care. Main Outcomes and Measures: Subgroups of FLEX participants were derived from an ITR estimating which participants would benefit from intervention, which would benefit from control conditions, and which would be indifferent. Multiple imputation by chained equations and reinforcement learning trees were used to estimate the ITR. Subgroups based on ITR pertaining to changes during 18 months in 3 univariate outcomes (ie, HbA1c percentage, QoL, and BMIz) and a composite outcome were compared by baseline demographic, clinical, and psychosocial characteristics. Results: Data from 216 adolescents in the FLEX trial were reanalyzed (166 [76.9%] non-Hispanic white; 108 teenaged girls [50.0%]; mean [SD] age, 14.9 [1.1] years; mean [SD] diabetes duration, 6.3 [3.7] years). For the univariate outcomes, a large proportion of FLEX participants had equivalent predicted outcomes under intervention vs usual care settings, regardless of randomization, and were assigned to the muted group (HbA1c: 105 participants [48.6%]; QoL: 63 participants [29.2%]; BMIz: 136 participants [63.0%]). Regarding the BMIz univariate outcome, mean baseline BMIz of participants assigned to the muted group was lower than that of those assigned to the intervention and control groups (muted vs intervention: mean difference, 0.48; 95% CI, 0.21 to 0.75; P = .002; muted vs control: mean difference, 0.86; 95% CI, 0.61 to 1.11; P < .001); this group also had a higher proportion of individuals with underweight or normal weight using weight status cutoffs (95 [69.9%] in muted group vs 24 [54.6%] in intervention group and 11 [30.6%] in control group; χ24 = 24.67; P < .001). The approach identified subgroups estimated to benefit based on HbA1c percentage (54 participants [25.0%]), QoL (89 participants [41.2%]), and BMIz (44 participants [20.4%]). Regarding the HbA1c percentage outcome, participants expected to benefit from the intervention did not have significantly higher baseline HbA1c percentages than those expected to benefit from usual care (9.4% vs 9.2%; difference, 0.2%; 95% CI, -0.16% to 0.56%; P = .44). However, participants in the muted group had higher mean HbA1c percentages at baseline than those assigned to the intervention or control groups (muted vs intervention: 9.9% vs 9.4%; difference, 0.5%; 95% CI, 0.13% to 0.89%; P = .02; muted vs control; 9.9% vs 9.2%; difference, 0.7%; 95% CI, 0.34% to 1.08%; P = .001). No significant differences were found between subgroups estimated to benefit in terms of the composite outcome from the FLEX intervention (91 participants [42.1%]) vs usual care (125 participants [57.9%]). Conclusions and Relevance: The precision medicine approach represents a conceptually and analytically novel approach to post hoc subgroup identification. More work is needed to understand markers of positive response to the FLEX intervention. Trial Registration: ClinicalTrial.gov identifier: NCT01286350.

Prevalence, characteristics, and diabetes management in children with comorbid autism spectrum disorder and type 1 diabetes.

OBJECTIVE: To determine autism spectrum disorder (ASD) prevalence within our pediatric type 1 diabetes (T1D) clinic population and determine clinical characteristics and technology used by individuals with both ASD and T1D compared to matched controls with T1D alone and compared to our overall pediatric T1D clinic. METHODS: Medical chart review showed 30 individuals with both ASD and type 1 diabetes (ASD + T1D). Controls (n = 90) were matched for age, sex, race/ethnicity, and T1D duration. ASD + T1D was compared to both matched controls and the pediatric T1D clinical population. RESULTS: ASD prevalence in the pediatric T1D population was 1.16% (CI 0.96-1.26). Compared to the T1D clinic, ASD + T1D had more males (93% vs 52%; P < 0.0001), lower hemoglobin A1c (HbA1c) (8.2% vs 8.9%; 66 vs 74 mmol/mol; P = 0.006), and lower insulin pump (CSII) use (37% vs 56%; P < 0.0001). No differences were found between ASD + T1D and matched controls in HbA1c or blood glucose checks per day. The ASD + T1D group was less likely to use CSII than matched controls (37% vs 61%; P = 0.03). HbA1c did not change after CSII initiation in ASD + T1D, but increased for matched controls. CONCLUSIONS: Prevalence of ASD in the pediatric T1D population is comparable to the general population in Colorado. Individuals with ASD may experience barriers limiting CSII use, but achieve equivalent glycemic control compared to those without ASD. CSII may be more effective in maintaining lower HbA1c over time in those with ASD than in those without ASD.

Understanding antagonism and synergism: A qualitative assessment of weight management in youth with Type 1 diabetes mellitus.

AIMS: No current clinical guidelines focus on weight management in youth with type 1 diabetes mellitus (T1DM). Our aim was to characterize the patient-perceived experience and barriers to weight management in youth with T1DM. METHODS: Participants were recruited from the University of North Carolina (n = 16, 56% female, 60% White, 50% insulin pump users, mean age 14.8 years, mean HbA1c 8.5% (69 mmol/mol)) and the University of Colorado (n = 18, 50% female, 80% white, 53% pump users, mean age 15.3 years, mean HbA1c 9.3% (78 mmol/mol)). Focus groups were stratified by sex and weight status (BMI cutoff = 25). Discussions were guided by a standardized set of questions, audio-taped, transcribed, and analyzed thematically using inductive qualitative methods. RESULTS: Youth with T1DM expressed four interrelated themes of antagonism between type 1 diabetes and weight management: dysregulated appetite, disruption of blood glucose levels associated with changing diet/exercise, hypoglycemia as a barrier to weight loss, and the overwhelming nature of dual management of weight and glycemic control, and two interrelated themes of synergism: improvement in shared, underlying heath behaviors and exercise as a tool for weight and glycemic control. Variation in emphasis of specific thematic elements was greatest across sex. Youth identified five major components of a weight management program for T1DM: intensified glucose management, healthy diet with known carbohydrate content, exercise, individualization and flexibility, and psychosocial and peer support. CONCLUSIONS: There is critical need for personalized, T1DM-specific weight recommendations to overcome disease-specific barriers to weight management in the context of T1DM.

Are children with type 1 diabetes safe at school? Examining parent perceptions.

OBJECTIVE: To describe parent perceptions of children's diabetes care at school including: availability of licensed health professionals; staff training; logistics of provision of care; and occurrence and treatment of hypo- and hyperglycemia; and to examine parents' perceptions of their children's safety and satisfaction in the school environment. RESEARCH DESIGN AND METHODS: A survey was completed by parents of children with type 1 diabetes from permissive (trained, non-medical school personnel permitted to provide diabetes care; N = 237) and non-permissive (only licensed health care professionals permitted to provide diabetes care; N = 198) states. RESULTS: Most parents reported that schools had nurses available for the school day; teachers and coaches should be trained; nurses, children, and parents frequently provided diabetes care; and hypo- and hyperglycemia occurred often. Parents in permissive states perceived children to be as safe and were as satisfied with care as parents in non-permissive states. CONCLUSIONS: Training non-medical staff will probably maximize safety of children with diabetes when a school nurse is not available.

Use of technology when assessing adherence to diabetes self-management behaviors.

During the last several decades, a proliferation of sophisticated technology has taken place to facilitate diabetes self-management and improve health outcomes. Blood glucose monitors, insulin pumps, and continuous glucose monitors have significant data storage capacity, which can be used to summarize diabetes health management and outcomes. In the absence of technology errors or failures, and in the context of the multiple psychosocial factors associated with nonadherence, these data have the potential to elucidate diabetes care because they reflect actual patient behaviors. This review provides a summary of the diabetes adherence literature in the context of current American Diabetes Association Clinical Practice Recommendations with a focus on studies that have used objective methods (ie, data derived from technology) to assess diabetes care provider and patient adherence in the areas of glucose monitoring; insulin administration and antihyperglycemic medications; medical nutrition therapy; and physical activity.

Predictors of study completion and withdrawal in a randomized clinical trial of a pediatric diabetes adherence intervention.

PURPOSE: Loss of participants in randomized clinical trials threatens the validity of study findings. The purpose of this study was to determine pre-randomization predictors of study completion status throughout the course of a randomized clinical trial involving young children with type 1 diabetes and their primary caregivers. METHODS: An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child's regular 3-month diabetes clinic visit. The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group. Among those who completed the study and regardless of treatment group, participants were categorized into two groups: On-Time Completers (n=41) and Late Completers (n=39). Demographic, disease, and psychosocial characteristics of children and their primary caregivers measured prior to study randomization were tested for their association with the participants' completion status (i.e., On-Time Completers, Late Completers, or Withdrawals). RESULTS: Of the 108 participants, 28 (25.9%) withdrew and 80 (74.1%) completed the study. On-Time Completers (i.e., study completed within 4 months of expected date) were more likely to have private insurance and primary caregivers with some college education. Late Completers (i.e., study completion took longer than 4 months) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression. Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home. CONCLUSIONS: Pre-randomization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence, permitting the investigators to develop retention strategies aimed at this high-risk group.