Evaluation of the longitudinal change in health behavior profiles across treatment groups in the TODAY clinical trial.

BACKGROUND: Individual health behaviors (ie, eating habits and sedentary lifestyle) are associated with type 2 diabetes (T2D). Health behavior profiles specific to adolescents with T2D have not been described. OBJECTIVE: To identify health behavior profiles in adolescents with T2D and examine how these profiles change over time. METHODS: Diet (via food frequency questionnaire) and activity behaviors (via 3-day physical activity recall) examined at baseline, 6 months, and 24 months from participants in the the Treatment Options for T2D in Adolescents and Youth (TODAY) study were used for this analysis. Latent profile analysis identified profiles of health behaviors within three time points, and latent transition probabilities were estimated to examine the change from baseline to 6 months (n = 450) and baseline to 24 months (n = 415). Multinomial logistic regressions were used to examine if the assigned TODAY treatment group (Metformin [Met], Met + Rosiglitazone [Rosi], or Met + Lifestyle) predicted change in health behavior profiles. RESULTS: Three profiles emerged: "most sedentary," "healthy eaters," and "active and eat most." At 6 months, 50% of males and 29% of females in the Met + Lifestyle treatment group improved in their health behavior profile. Among males only, the Met + Lifestyle treatment group were more likely to improve their profiles from baseline to 6 months (P = .01). CONCLUSIONS: Three health behavior profiles emerged and shifted over time. A high quality, lifestyle intervention had little effect on improving health behavior profiles. Optimizing outcomes in youth with T2D might require more robust and multifaceted interventions beyond family-level lifestyle, including more extensive psychosocial intervention, novel medication regimen, or bariatric surgery.

Trust in hybrid closed loop among people with diabetes: Perspectives of experienced system users.

Automated closed loop systems will greatly change type 1 diabetes management; user trust will be essential for acceptance of this new technology. This qualitative study explored trust in 32 individuals following a hybrid closed loop trial. Participants described how context-, system-, and person-level factors influenced their trust in the system. Participants attempted to override the system when they lacked trust, while trusting the system decreased self-management burdens and decreased stress. Findings highlight considerations for fostering trust in closed loop systems. Systems may be able to engage users by offering varying levels of controls to match trust preferences.

Self-Monitoring of Blood Glucose in Youth-Onset Type 2 Diabetes: Results From the TODAY Study.

OBJECTIVE: To determine whether self-monitoring of blood glucose (SMBG) is associated with lower HbA1c in youth with type 2 diabetes taking oral medications only or after starting insulin for persistently elevated HbA1c. RESEARCH DESIGN AND METHODS: Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study participants (n = 699) taking oral medications were asked to perform SMBG twice daily. After reaching primary outcome (PO) (HbA1c ≥8% [64 mmol/mol]) over 6 months or an inability to wean from temporary insulin because of metabolic decompensation), insulin glargine was started. HbA1c and percent of SMBG (SMBG%) (percent days when the meter was used one or more times) before and after PO were analyzed. RESULTS: SMBG declined over time and was inversely related to HbA1c (P < 0.0001). Of 298 youth who reached PO and started insulin, 282 had SMBG data. At PO, mean ± SD age was 15.8 ± 2.3 years, BMI 35.5 ± 7.9 kg/m2, and HbA1c 9.6 ± 2.0% (81 ± 21.9 mmol/mol); 65.3% were female. Median SMBG% was 40% at PO, which increased to 49% after 6 months and fell to 41% after 1 year on insulin. At PO, 22% of youth checked ≥80% of days, which increased to 25% and fell to 19% after 6 and 12 months using insulin, respectively. At PO, compared with those who checked <80%, youth who checked ≥80% were younger and with a lower BMI, HbA1c, and blood pressure. SMBG ≥80% was associated with ≥1% reduction in HbA1c at 6 and 12 months after insulin initiation. CONCLUSIONS: Low SMBG adherence was common and associated with higher HbA1c. Optimal SMBG frequency in youth using or not using insulin, and whether less frequent SMBG is a marker for overall worse self-care, require further study.

Psychosocial and Human Factors During a Trial of a Hybrid Closed Loop System for Type 1 Diabetes Management.

BACKGROUND: Hybrid closed loop (HCL) systems are designed to automate insulin delivery to improve type 1 diabetes (T1D) outcomes and reduce user burden and distress. Because the systems only automate some aspects of diabetes care, psychosocial and human factors remain an important consideration in their use. Thus, we examined whether psychosocial and human factors (i.e., distress related to diabetes management, fear of hypoglycemia, and technology attitudes) would (1) change after using the system and (2) predict glycemic outcomes during the trial. SUBJECTS AND METHODS: Fourteen adults and 15 adolescents with T1D participated in a multisite clinical trial of an investigational version of the MiniMed™ 670G system (Medtronic, Northridge, CA) over 4 to 5 days in a semisupervised outpatient setting. Users completed surveys assessing psychosocial and human factors before beginning the HCL system and at the conclusion of the study. t-Tests and regression analyses were conducted to examine whether these factors changed following trial exposure to the HCL system and predicted glycemic outcomes during the trial. RESULTS: Diabetes management distress decreased and diabetes technology attitudes became more positive over the trial period. Fear of hypoglycemia did not change over the trial period. There was a trend toward greater pretrial management distress predicting less time in range during the trial, controlling for time in range before the trial. CONCLUSIONS: Results suggest that this system is promising for enhancing technology attitudes and reducing management distress. Psychosocial factors, such as management distress, may negatively impact glycemic outcomes and should be a priority area for further investigation.

Expectations and Attitudes of Individuals With Type 1 Diabetes After Using a Hybrid Closed Loop System.

Purpose The first hybrid closed loop (HCL) system, which automates insulin delivery but requires user inputs, was approved for treatment of type 1 diabetes (T1D) by the US Food and Drug Administration in September 2016. The purpose of this study was to explore the benefits, expectations, and attitudes of individuals with T1D following a clinical trial of an HCL system. Methods Thirty-two individuals with T1D (17 adults, 15 adolescents) participated in focus groups after 4 to 5 days of system use. Content analysis generated themes regarding perceived benefits, hassles, and limitations. Results Some participants felt misled by terms such as "closed loop" and "artificial pancreas," which seemed to imply a more "hands-off" experience. Perceived benefits were improved glycemic control, anticipated reduction of long-term complications, better quality of life, and reduced mental burden of diabetes. Hassles and limitations included unexpected tasks for the user, difficulties wearing the system, concerns about controlling highs, and being reminded of diabetes. Conclusion Users are willing to accept some hassles and limitations if they also perceive health and quality-of-life benefits beyond current self-management. It is important for clinicians to provide a balanced view of positives and negatives to help manage expectations.

Benefits and barriers to participating in longitudinal research of youth-onset type 2 diabetes: Results from the TODAY retention survey.

BACKGROUND/AIMS: Conducting longitudinal research related to chronic illness in adolescents is inherently challenging due to developmental changes and psychosocial stressors. Participants in the Treatment Options for type 2 Diabetes in Adolescents and Youth clinical trial were socioeconomically disadvantaged as well. This study assessed attitudes and beliefs about retention in Treatment Options for type 2 Diabetes in Adolescents and Youth to shed light on the factors that potentially promote and detract from the likelihood of sustained participation. METHODS: After an average 7.3 years of follow-up (range 4.9-9.5), Treatment Options for type 2 Diabetes in Adolescents and Youth participants completed a survey examining their perceptions of the benefits and barriers to sustained involvement in the protocol. RESULTS: The most common reasons for staying in Treatment Options for type 2 Diabetes in Adolescents and Youth included having a strong relationship with the medical team, getting study-provided diabetes care, access to free diabetes medicine and supplies, and being part of a large study to learn more about how to care for youth-onset type 2 diabetes. The most commonly endorsed challenges included scheduling conflicts, possibly disappointing others, difficulties getting to study visits, and the occurrence of other medical issues. CONCLUSIONS: Similar to other published reports, a supportive relationship with study staff was commonly endorsed as a benefit of engagement in the longitudinal study, suggesting that rapport, staff consistency, and relationship quality are important components of optimal retention. Moreover, our findings suggest the value of trying to remove logistical barriers, such as transportation and scheduling challenges, in order to promote long-term participation in research. Further research is recommended to evaluate factors that contribute to attrition versus retention in an a priori manner within longitudinal studies, especially protocols involving cohorts that are more vulnerable to attrition due to developmental transitions and/or socioeconomic challenges. Additional efforts to optimize quantitative and qualitative measurement of barriers would also help to expand our understanding of how to optimally retain participants in longitudinal protocols.

Longitudinal Correlates of Health Risk Behaviors in Children and Adolescents with Type 2 Diabetes.

OBJECTIVES: To characterize, during a 2-year period, the proportion of youth with type 2 diabetes (T2D) enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth study that reported ever at least trying smoking cigarettes and/or drinking alcohol. STUDY DESIGN: Longitudinal data were examined for participants with T2D ages 10-18 years at baseline. Youth psychosocial, parent/family, environmental, and biological correlates of trying health risk behaviors were tested via cross-sectional multivariate models at each time point. Longitudinal models were explored for selected factors. RESULTS: Data were obtained from the Treatment Options for Type 2 Diabetes in Adolescents and Youth study's ethnically diverse participants at baseline (N=644), 6-month (N=616), and 24-month (N=543) assessments. The percentage of youth ever trying only smoking remained stable at 4%; only drinking alcohol increased from 17% to 26%, and both smoking and drinking increased from 10% to 18% during the 2-year period. Factors related to trying health risk behaviors were older age, male sex, non-Hispanic white race-ethnicity, lower grades, more depressive symptoms, and stressful life events. Depressive symptoms, stressful life events, and body mass index Z-score (the latter with smoking only) were related to engagement in health risk behaviors over time. CONCLUSIONS: Youth with T2D who are already at risk for health complications and who reported engaging in activities that further increase the likelihood of life-threatening morbidities were characterized. Although most correlates of trying these risk behaviors are nonmodifiable, intervention efforts may need to focus on potentially modifiable factors, such as depressive symptoms and lower grades.

Effects of comorbid conditions on health-related quality of life in youth with Type 2 diabetes: the TODAY clinical trial.

AIM: To explore associations between health-related quality of life (HRQOL) and comorbidities in youth with Type 2 diabetes. PATIENTS & METHODS: Of 699 youth in the TODAY study, 685 (98%) had baseline HRQOL data, 649 (93%) at 6 months and 583 (83%) at 24 months. Comorbidities were defined by sustained abnormal values and treatment regimens. RESULTS: At baseline, 22.2% of participants demonstrated impaired HRQOL. Only depressive symptoms distinguished those with versus without impaired HRQOL and were significantly related to later impaired HRQOL (p < 0.0001). A significant correspondence between impaired HRQOL and number of comorbidities (p = 0.0003) was noted, but was driven by the presence of depressive symptoms. CONCLUSION: Results emphasize the need for evaluation of depressive symptoms. Other comorbidities did not have a significant impact on HRQOL in this cohort.

Relationships among stressful life events and physiological markers, treatment adherence, and psychosocial functioning among youth with type 2 diabetes.

OBJECTIVE: To examine the relationships between stressful life events and physiological measures, adherence to prescribed oral medication regimens, depressive symptoms, and impaired quality of life (QoL) in adolescents with recent-onset type 2 diabetes (T2D). STUDY DESIGN: Data were collected from 497 ethnically diverse participants (66% female) in the final year of the Treatment Options for Type 2 Diabetes in Adolescents and Youth multicenter clinical trial. Exposure to 32 possible events over the previous year and rating of subsequent distress were collected by self-report and summarized as a major stressors score. This score was analyzed for relationship to glycemic control (hemoglobin A1c and treatment failure), body mass index, diagnosis of hypertension or triglyceride dyslipidemia, adherence to a prescribed oral medication regimen, presence of depressive symptoms, and impaired QoL. RESULTS: The total number of major stressful life events in the adolescents with T2D was calculated, with 33% reporting none, 67% reporting ≥ 1, 47% reporting ≥ 2, 33% reporting ≥ 3, and 20% reporting ≥ 4. There were no associations between the major stressors score and physiological measures or diagnosis of comorbidities. The odds of medication nonadherence increased significantly from those reporting ≥ 1 major stressor (OR, 1.58; P = .0265) to those reporting ≥ 4 major stressors (OR, 2.70; P = .0009). Significant odds of elevated depressive symptoms and impaired QoL were also found with increased reporting of major stressors. CONCLUSION: Exposure to major stressful life events is associated with lower adherence to prescribed oral medication regimens and impaired psychosocial functioning in adolescents with T2D.

Depression and quality of life in youth-onset type 2 diabetes mellitus.

Type 2 Diabetes Mellitus (T2DM) was characteristically an adult-onset illness until recently, when it became recognized as an increasing problem among youth in conjunction with escalating rates and associated risks of pediatric. Youth-onset T2DM is associated with a range of psychosocial risk factors, and research underscores the relevancy of depressive symptoms and quality of life factors in illness diagnosis, management and prognosis. This review paper summarizes available findings on depression and health-related quality of life for youth-onset T2DM, and provides recommendations for clinical practice and a conceptual framework for further studies.

Psychological functioning in adolescents with obesity co-morbidities.

BACKGROUND: An understanding of the relationships among obesity severity, medical co-morbidities, and psychological complications is important in the design of interventions to encourage overweight youth and families to accomplish healthy lifestyle changes. METHODS: We evaluated associations among psychological status, diagnosed medical co-morbidities consistent with components of the metabolic syndrome, and BMI among 166 obese adolescents (11-18 years) referred for endocrinology consultation. We hypothesized that there would be higher levels of psychological distress among youth with more diagnosed components of the metabolic syndrome (i.e., more medical co-morbidities associated with obesity). RESULTS: Contrary to expectation, we found that meeting criteria for extreme obesity alone was more predictive of psychological difficulties. CONCLUSIONS: The degree of obesity may be more relevant than the number of associated medical co-morbidities in impacting psychological health. It is important to recognize individual differences between patients in terms of identifying motivating goals for accomplishing weight management.

Health-related quality of life in adolescents with comorbidities related to obesity.

INTRODUCTION: Psychosocial correlates of medically complex obesity are poorly understood in adolescents. METHODS: Health-related quality of life was examined among 111 obese adolescents with medical comorbidities. RESULTS AND CONCLUSION: A higher body mass index and greater number of comorbidities were associated with diminished health-related quality of life, thus underscoring the relevance of psychosocial functioning in obese youth.

Asthma symptom perception and obesity in children.

This study examined the relationship between obesity and asthma symptom perception in 200 youth with asthma. Repeated subjective and objective peak flow measurements were summarized using the Asthma Risk Grid (Klein et al., 2004), resulting in Accurate, Symptom Magnification and Danger Zone scores. Analyses were stratified by age and included ethnicity. For younger children, obesity was not significantly related to perception scores. For older children, a significant obesity-by-ethnicity interaction for Accurate Symptom Perception scores indicated that obese white children had lower accuracy than white nonobese children, while there was no difference for obese versus nonobese minority children. Obesity was also related to higher Symptom Magnification scores regardless of ethnicity for older children. These findings suggest that obesity may complicate asthma management by interfering with the ability to accurately perceive symptoms for some patients. More remains to be learned about the role of sociodemographic factors underlying this relationship.

Encouraging physical activity in pediatric asthma: a case-control study of the wonders of walking (WOW) program.

OBJECTIVES: The complex overlap between asthma and obesity may be explained in part by activity avoidance in asthma. We compared responses to a walking intervention between matched groups of children with and without asthma. We expected youth with asthma to have lower baseline and post-intervention activity levels. Psychosocial, demographic, and physiologic correlates of activity were also examined. DESIGN/PARTICIPANTS: We compared baseline and post-intervention activity levels among 59 children aged 10-16 with well-controlled asthma and 59 healthy matched controls. Participants completed spirometry, physical examination, anthropometric measurement, and psychosocial questionnaires. INTERVENTION/OUTCOME MEASURE: Participants wore blinded calibrated pedometers for a baseline typical activity week, returning to complete the Wonders of Walking (WOW) intervention, followed by a week of post-intervention pedometer monitoring. RESULTS: Contrary to expectation, no differences between cases (median steps = 6,348/day) and controls (median steps = 6,825/day) in baseline activity were found. Response to the WOW intervention was comparable, with both groups demonstrating an increase of approximately 1,485 steps per day (equivalent to more than 5 additional miles walked during the post-intervention week). Health beliefs did not correlate to activity at baseline or intervention response. No significant associations between activity and asthma control, FEV1, or duration of diagnosis were found. Intervention response was comparable across racial/ethnic groups, children versus adolescents, and between normal weight and overweight youth. CONCLUSIONS: Contrary to expectation, we found similar rates of objectively measured physical activity among youth with well-controlled asthma and controls. Importantly, we documented statistically significant increases in physical activity across both groups following a brief, pedometer-based intervention. The intervention was successful even among typically sedentary groups, and represents an effective, safe, and inexpensive walking program.