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Background We describe the implementation and evaluation of an integrated, stepped care model aimed to identify and address the concerns of adolescents with type 1 diabetes (T1D) associated with diabetes-related quality of life (DRQoL), emotional well-being and depression. Methods The care model with 4 steps: 1) Systematic identification and discussion of concerns salient to adolescents; 2) Secondary screening for depressive symptoms when indicated; 3) Developing collaborative treatment plans with joint physical and mental health goals; and 4) Psychiatric assessment and embedded mental health treatment; was implemented into an ambulatory pediatric diabetes clinic and evaluated using quantitative and qualitative methods. Results There were 236 adolescents (aged 13-18 years) with T1D that were enrolled in the care model. On average adolescents identified 3 concerns associated with their DRQoL and 25% indicated low emotional well-being. Fifteen adolescents received a psychiatric assessment and embedded mental health treatment. Both adolescents and caregivers were appreciative of a broader, more holistic approach to their diabetes care and to the greater focus of the care model on adolescents, who were encouraged to self-direct the conversation. Parents also appreciated the extra level of support and the ability to receive mental health care for their adolescent from their own diabetes care team. Conclusion The initial findings from this project indicate the acceptability and, to limited extent, the feasibility of an integrated stepped care model embedded in an ambulatory pediatric diabetes clinic led by an interdisciplinary care team. The care model facilitated the identification and discussion of concerns salient to youth and provided a more holistic approach. This article is protected by copyright. All rights reserved.

Purpose of review We aimed to systematically evaluate the content validity of patient-reported outcome measures (PROMs) specifically developed to measure (aspects of) health-related quality of life (HRQOL) in people with type 2 diabetes. A systematic review was performed in PubMed and Embase of PROMs measuring perceived symptoms, physical function, mental function, social function/participation, and general health perceptions, and that were validated to at least some extent. Content validity (relevance, comprehensiveness, and comprehensibility) was evaluated using COSMIN methodology. Recent findings We identified 54 (different versions of) PROMs, containing 150 subscales. We found evidence for sufficient content validity for only 41/150 (27%) (subscales of) PROMs. The quality of evidence was generally very low. We found 66 out of 150 (44%) (subscales of) PROMs with evidence for either insufficient relevance, insufficient comprehensiveness, or insufficient comprehensibility. For measuring diabetes-specific symptoms, physical function, mental function, social function/participation, and general health perceptions, we identified one to 11 (subscales of) PROMs with sufficient content validity, although quality of the evidence was generally low. For measuring depressive symptoms, no PROM with sufficient content validity was identified. Summary For each aspect of HRQL, we found at least one PROM with sufficient content validity, except for depressive symptoms. The quality of the evidence was mostly very low.

IntroductionThe Problem Areas of Diabetes (PAID) questionnaire is a frequently used measure to assess diabetes-distress. The aim of this study was to identify clinically meaningful levels of diabetes-distress, using latent class analyses (LCA), and to determine which groups were at increased risk of elevated diabetes-distress in terms of sex, age, type of diabetes and glycaemic control.MethodsData were derived from four studies (total N=2966, 49% female, age range 18–95 years, 43% type 1 diabetes, diabetes duration range 0–79 years). LCAs were performed to examine possible latent groups in the distribution of answers on the individual PAID items. Demographic and diabetes-related characteristics were added to the model to estimate their effects on latent class membership and receiver operating curves curves to determine cut-offs.ResultsThree levels of diabetes distress were distinguished with defined cut-off scores and labelled as: low, moderate and high diabetes distress. Levels of distress did not associate with distinct clusters of items. Older people were more likely to be part of the low distress class; women and people with high HbA1c were more likely to be part of the high distress class. Sensitivity and specificity of the commonly used cut-off of 40 for high distress are 0.95 and 0.97, respectively. To distinguish the moderate distress group, cut-off scores of 17 and 39 are optimal with a sensitivity of 0.93 and a specificity of 0.94.ConclusionThree levels of diabetes-distress can be distinguished: low, moderate and high diabetes distress. Younger people, women and people with poor glycaemic control are at an increased risk for high levels of distress. A cut-off of 40 is satisfactory to detect people with high levels of diabetes-distress; a score of 0–16 indicates low diabetes distress and a score of 17–39 moderate diabetes distress.

This narrative review aims to examine the value of addressing mental disorders as part of the care of people with type 1 and type 2 diabetes in terms of four components of precision medicine. First, we review the empirical literature on the role of common mental disorders in the development and outcomes of diabetes (precision prevention and prognostics). We then review interventions that can address mental disorders in individuals with diabetes or at risk of diabetes (precision treatment) and highlight recent studies that have used novel methods to individualise interventions, in person and through applications, based on mental disorders. Additionally, we discuss the use of detailed assessment of mental disorders using, for example, mobile health technologies (precision monitoring). Finally, we discuss future directions in research and practice and challenges to addressing mental disorders as a factor in precision medicine for diabetes. This review shows that several mental disorders are associated with a higher risk of type 2 diabetes and its complications, while there is suggestive evidence indicating that treating some mental disorders could contribute to the prevention of diabetes and improve diabetes outcomes. Using technologically enabled solutions to identify mental disorders could help individuals who stand to benefit from particular treatments. However, there are considerable gaps in knowledge and several challenges to be met before we can stratify treatment recommendations based on mental disorders. Overall, this review demonstrates that addressing mental disorders as a facet of precision medicine could have considerable value for routine diabetes care and has the potential to improve diabetes outcomes. Graphical abstract

Introduction For the analysis of clinical effects, multiple imputation (MI) of missing data were shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to trial-based economic evaluations. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost and effect data. Methods Two-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10, 25, and 50% missing data in follow-up costs and effects, assuming a Missing At Random (MAR) mechanism. Six different strategies were compared using empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). These strategies were: LLM alone (LLM) and MI with LLM (MI-LLM), and, as reference strategies, mean imputation with LLM (M-LLM), seemingly unrelated regression alone (SUR-CCA), MI with SUR (MI-SUR), and mean imputation with SUR (M-SUR). Results For costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, SUR-CCA, and M-SUR, with smaller EBs and RMSEs as well as CRs closers to nominal levels. However, even though LLM, MI-LLM and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 and 25% missing data. At 50% missing data, all strategies resulted in relatively high EBs and RMSEs for costs. Conclusion LLM should be combined with MI when analyzing trial-based economic evaluation data. MI-SUR is more efficient and can also be used, but then an average intervention effect over time cannot be estimated.

In this article the bio-medical and psychological aspects of diabetes mellitus and their interactions are reviewed. Main types of diabetes are distinguished, all characterized by elevated blood glucose levels (hyperglycemia) and related health risks, but with different risk factors, age of onset, clinical features and treatment requirements. The cognitive, emotional and behavioral ramifications of living with and self-managing diabetes are reviewed, along with psychological co-morbidities. There is a clear need for integrating psychological assessment and support into diabetes care, with an important role for diabetes health professionals as well as clinical health psychologists and other mental health workers. The article concludes with some future directions for behavioral research in diabetes.

IntroductionFor the analysis of clinical effects, multiple imputation (MI) of missing data was shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to cost estimates from trial-based economic evaluations, that are generally right-skewed. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost-effectiveness data.MethodsTwo-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10 percent, 25 percent, and 50 percent missing data in costs and effects, assuming a Missing At Random (MAR) mechanism. Statistical performance of six different methodological strategies was compared in terms of empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). Six strategies were compared: (i) LLM (LLM), (ii) MI prior to LLM (MI-LLM), (iii) mean imputation prior to LLM (M-LLM), (iv) complete-case analysis prior to seemingly unrelated regression (CCA-SUR), (v) MI prior to SUR (MI-SUR), and (vi) mean imputation prior to SUR (M-SUR). To evaluate the impact on the probability of cost-effectiveness at different willingness-to-pay [WTPs] thresholds, cost-effectiveness analyses were performed by applying the six strategies to two empirical datasets with 9% and 50% of missing data, respectively.ResultsFor costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, CCA-SUR, and M-SUR, as indicated by smaller EBs and RMSEs, as well as CRs closer to the nominal levels of 0.95. However, even though LLM, MI-LLM, and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 percent and 25 percent missing data. At 50 percent missing data, all strategies resulted in relatively high EBs and RMSEs for costs. In both empirical datasets, LLM, MI-LLM, and MI-SUR all resulted in similar probabilities of cost-effectiveness at different WTPs.ConclusionsWhen opting for using LLM for analyzing trial-based economic evaluation data, researchers are advised to multiply impute missing values first. Otherwise, MI-SUR may also be used.

Introduction Psychological distress and fatigue are common in persons with diabetes, adversely affecting quality of life and complicating diabetes self-management. Offering diabetes-specific self-guided cognitive behavioral therapy (CBT) may be helpful for persons with diabetes and mild symptoms of psychological distress and fatigue. We are the first to test the feasibility and user experiences of a web-based self-help app called ‘MyDiaMate’ in adults with type 1 and type 2 diabetes. Methods and materials MyDiaMate was developed in close collaboration with persons with diabetes and professionals, building on elements from existing (guided) diabetes-specific CBT interventions. The study was advertised, offering free access to the app for adults with diabetes for a period of three months. Feasibility and user experiences were tested in a non-randomized study with pre- and post- measurements and interviews in a small sample.. In addition usage of the app was studied using log-data.. Results In total N = 55 adults with diabetes signed up for the study. Mean age was M = 42.7 (SD = 15.6), mostly women (n = 39, 70.9%), higher educated (n = 36, 65.5%), and diagnosed with type 1 diabetes (n = 37, 67.3%). About half reported current or a history of psychological complaints. All the participants completed baseline assessments, and n = 32 participants (58%) completed the follow-up questionnaire. Main reasons for participating in the study were: to preserve or improve mental fitness (40.6%), curiosity (25.0%) and wanting to contribute to research (34.4%). No major technical issues were encountered in accessing or using the app. The app was opened at least once by n = 51 participants, median use of the modules was 28 min (1–80) within a period of 1 to 92 days (median = 10). Almost all participants (n = 50, 98.0%) opened the basic module ‘Diabetes in balance’, of whom 32 (62.7%) completed this module. ‘My mood’ and ‘My energy’ were opened by n = 40 (78.4%) and n = 32 (62.7%) participants, respectively, and completed by n = 21 (52.5%) and n = 9 (28.1%) of the participants. Of all participants, 40.6% would recommend the app to others living with diabetes. Conclusions This study confirmed the feasibility of MyDiaMate as a diabetes-specific self-guided app for adults wishing to preserve or improve their psychological health. While user experiences were overall positive, further tailoring the content to individual needs and preferences could enhance uptake, usage and appreciation. Future research should explore its effectiveness in a randomized controlled trial., Highlights • MyDiaMate is the first diabetes-specific self-help app to help prevent and reduce psychological distress and fatigue. • The study shows promising results in terms of feasibility and user experiences of the app. • Personalizing content may further improve engagement and appreciation. • Further research should test the efficacy with regard to reduction and prevention of psychological distress and fatigue.

OBJECTIVE Successful self-management of type 1 diabetes requires cognitive skills such as executive functioning (EF). In the transition to adolescence, youth take over responsibility for diabetes management. We set out to test: 1) the association between EF and glycemic control over time and 2) whether this association was moderated by: a) youth, shared, or parent responsibility for diabetes management and b) youth’s age. RESEARCH DESIGN AND METHODS Within the Diabetes IN DevelOpment study (DINO), parents of youth with type 1 diabetes (8–15 years at baseline; N = 174) completed a yearly assessment over 4 years. Glycemic control (HbA1c) was derived from hospital charts. Youth’s EF was measured using the Behavior Rating Inventory of Executive Functioning (BRIEF)-parent report. The Diabetes Family Responsibility Questionnaire (DFRQ)-parent report was used to assess diabetes responsibility (youth, shared, and parent). Linear generalized estimating equations were used to analyze data including youth’s sex, age, and age of diabetes onset as covariates. RESULTS Relatively more EF problems are significantly associated with higher HbA1c over time (β = 0.190; P = 0.002). More EF problems in combination with less youth responsibility (β = 0.501; P = 0.048) or more parental responsibility (β = −0.767; P = 0.006) are significantly associated with better glycemic control over time. Only age significantly moderates the relationship among EF problems, shared responsibility, and glycemic control (β = −0.024; P = 0.019). CONCLUSIONS Poorer EF is associated with worse glycemic control over time, and this association is moderated by responsibility for diabetes management tasks. This points to the importance of EF when youth take over responsibility for diabetes management in order to achieve glycemic control.

OBJECTIVE: Externalizing behavior (i.e., conduct problems, hyperactivity) and executive function (EF) problems in children and adolescents with type 1 diabetes (T1D) have been associated with worse diabetes-related and psychosocial outcomes but have not been examined in relationship to each other. We aimed to examine whether externalizing behavior is associated with HbA1c and whether this relationship is mediated by EF problems, specifically metacognition (i.e., ability to initiate, plan, organize and monitor behavior) and behavioral regulation (i.e., impulse control, regulation of emotion and behavior). RESEARCH DESIGN AND METHODS: Cohorts of Belgian and Dutch parents of children and adolescents (6-18 years) with T1D filled out questionnaires on externalizing behavior (Strengths and Difficulties Questionnaire; SDQ) and EF (Behavior Rating Inventory of Executive Function; BRIEF) composite scales. Treating physicians collected HbA1c values. Mediation analyses were performed separately for the BRIEF composite Metacognition and Behavior Regulation scales, correcting for age, sex and diabetes duration. RESULTS: The 335 parents of children and adolescents with T1D (mean age 12.3 ± 2.8 SD; mean HbA1c 7.6% ± 1.1 SD [60 mmol/mol ± 12.0 SD]; mean diabetes duration 5.3 ± 3.6 SD; 49.6% female) participated. Analyses showed that the association between externalizing behavior and HbA1c is mediated by metacognition (ab path Point estimate = 0.05 BCa CI 95% 0.02-0.08), and not behavioral regulation. CONCLUSIONS: Results uncovered the influence externalizing behavior may have on EF problems in the metacognition domain, which in turn seem to influence HbA1c. Clinicians should be mindful of these EF problems when working with children and adolescents displaying externalizing behavior, and not only target behavioral but also cognitive processes. ispartof: PEDIATRIC DIABETES vol:22 issue:3 pages:503-510 ispartof: location:Denmark status: published

Aims To systematically review the literature regarding the association between glucose variability (GV) and mood in adults with diabetes, appraise the used methods and make suggestions for future research. Methods A systematic review of literature published up to May 2019 was performed. Abstracts and full texts were screened independently in duplicate. Experimental and observational studies reporting the association between GV and mood in adults with type 1 diabetes or type 2 diabetes were evaluated. A descriptive analysis of the extracted data was conducted, along with a quality assessment. Results Out of the 2.316 studies screened, eight studies met our criteria. Studies used a variety of measures and metrics to determine GV and mood. Four studies used continuous glucose monitoring (CGM). An association between GV and mood was found in four studies when correlating either postprandial glucose rate of increase with current mood or multiday GV with mood measured retrospectively. The other four studies did not find any association. Conclusions There is no clear empirical support for a link between GV and mood in adults with type 1 and type 2 diabetes. More rigorous research is warranted using CGM and ecological momentary assessment of mood to assess if and under what conditions an association between GV and mood exists., The literature regarding the association between glucose variability (GV) and mood in adults with diabetes is systematically reviewed. Methods used are summarized and evaluated, and suggestions for future research and clinical implications are made.

Aim: EF (ability to initiate, plan, monitor behavior) impacts self-care and glycemic control in teens with T1D. We examined demographics, insulin therapy, A1c, and EF in 3 international cohorts of teens with T1D. Methods: Parents of 337 teens (13-18) with T1D from Belgium (BE), Netherlands (NL), and U.S. completed the BRIEF to assess teen EF. Parents/medical records provided demographic and diabetes data. BRIEF score ≥60 (composite score or either of 2 main indices) defined EF problems. Logistic regression determined associations of EF problems with A1c ( Results: Teens (54% male; 27% BE, 24% NL, 49% U.S.) were 15.0±1.5 yrs old with T1D duration 7.4±4.0 years, A1c 8.1±1.2%, 61% pump. Teens from BE, NL, U.S. differed with respect to A1c (7.4±1.0, 8.1±1.3, 8.5±1.2%) and pump use (27%, 72%, 74%) (all p Conclusion: In an international sample, teens with T1D and EF problems were twice as likely to have suboptimal A1c. Given country differences in pump use in teens with EF problems, future studies can assess potential benefit of technology in at-risk teens. Disclosure E.R. Goethals: None. M. de Wit: None. L.K. Volkening: None. K. Luyckx: None. K. Casteels: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US. Funding Iacocca Family Foundation; National Institutes of Health (P30DK036836, R01DK095273, K12DK094721); JDRF (2-SRA-2014-253-M-B)

This study compares the five-level EuroQol five-dimension questionnaire (EQ-5D-5L) crosswalks and the 5L value sets for England, the Netherlands, and Spain and explores the implication of using one or the other for the results of cost-utility analyses. Data from two randomized controlled trials in depression and diabetes were used. Utility value distributions were compared, and mean differences in utility values between the EQ-5D-5L crosswalk and the 5L value set were described by country. Quality-adjusted life years (QALYs) were calculated using the area-under-the-curve method. Incremental cost-effectiveness ratios (ICERs) were calculated, and uncertainty around ICERs was estimated using bootstrapping and graphically shown in cost-effectiveness acceptability curves. For all countries investigated, utility value distributions differed between the EQ-5D-5L crosswalk and 5L value set. In both case studies, mean utility values were lower for the EQ-5D-5L crosswalk compared with the 5L value set in England and Spain, but higher in the Netherlands. However, these differences in utility values did not translate into relevant differences across utility estimation methods in incremental QALYs and the interventions' probability of cost-effectiveness. Thus, our results suggest that EQ-5D-5L crosswalks and 5L value sets can be used interchangeably in patients affected by mild or moderate conditions. Further research is needed to establish whether these findings are generalizable to economic evaluations among severely ill patients.

Purpose of ReviewThis manuscript describes how person-reported outcomes (PROs) can be utilized in care for young people with diabetes in the context of motivation.Recent FindingsThe use of person-reported outcome measures (PROMS) in clinical care is feasible and acceptable, and helps focus the clinical encounter on life domains important to the person with diabetes. Results with regard to impact on self-management and glycemic outcomes are limited. Motivation is an important factor for self-management. Based on self-determination theory, autonomy-supportive, person-centered, and collaborative communication by diabetes care providers is associated with better outcomes. PROMs can facilitate this conversation.SummaryUnderstanding of youth motivation for maintaining or improving self-management behaviors requires a person-centered approach. PROMs can be used to facilitate an autonomy-supportive and person-centered conversation in clinical care. Training diabetes care providers in autonomy-supportive, person-centered conversation skills to discuss PROs might help to tap into youth’s motivation, but further research is needed.

Objective To develop and validate new measures of diabetes-specific health-related quality of life (HRQOL) for people with type 1 diabetes (T1D) that are brief, developmentally appropriate, and usable in clinical research and care. Here we report on the phases of developing and validating the self-report Type 1 Diabetes and Life (T1DAL) measures for children (age 8–11) and adolescents (age 12–17). Methods Measure development included qualitative interviews with youth and parents (n = 16 dyads) followed by piloting draft measures and conducting cognitive debriefing with youth (n = 9) to refine the measures. To evaluate the psychometric properties, children (n = 194) and adolescents (n = 257) at three T1D Exchange Clinic Network sites completed the age-appropriate T1DAL measure and previously validated questionnaires measuring related constructs. Using psychometric data, the investigators reduced the length of each T1DAL measure to 21 and 23 items, respectively, and conducted a final round of cognitive debriefing with six children and adolescents. Results The T1DAL measures for children and adolescents demonstrated good internal consistency (α = 0.84 and 0.89, respectively) and test–retest reliability (r = 0.78 and 0.80, respectively). Significant correlations between the T1DAL scores and measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, and diabetes strengths demonstrated construct validity. Correlations with measures of self-management (child and adolescent) and glycemic control (adolescent only) demonstrated criterion validity. Factor analyses indicated four developmentally specific subscales per measure. Participants reported satisfaction with the measures. Conclusions The new T1DAL measures for children and adolescents with T1D are reliable, valid, and suitable for use in care settings and clinical research.

The aim of this study was to evaluate whether psychological distress modifies the effect of continuous glucose monitoring (CGM) in patients with type 1 diabetes (T1D) and impaired awareness of hypoglycemia. Fifty-two patients with T1D and impaired awareness of hypoglycemia participated in an earlier reported randomized crossover trial with two 16-week intervention periods comparing CGM with self-monitoring of blood glucose (SMBG). During the CGM phase, time spent in euglycemia (4-10 mmol/L), the primary outcome, was 9.6% higher compared with the SMBG phase (P < 0.0001). Psychological distress was operationalized as low emotional well-being (World Health Organization Well-being Index 5 [WHO-5] < 50) high diabetes-related distress (Problem Areas in Diabetes 5 [PAID-5] ≥ 8) and/or high fear of hypoglycemia (Hypoglycemia Fear Survey [HFS] Worry > mean HFS Worry score +1 standard deviation). Modifying effects were assessed by analyzing psychological distress score × intervention - interaction effects. Results showed that both the low emotional well-being group and normal emotional well-being group had equal glycemic outcomes during the CGM phase. High diabetes distress and elevated fear of hypoglycemia did not result in significant interaction effects for glycemic outcomes. This study demonstrated that CGM is equally effective in terms of glycemic improvements in high versus low distressed patients with T1D and impaired awareness of hypoglycemia.

OBJECTIVE: Grounded in Self-Determination Theory, this study examines the role of parental expectations and communication style (ie, in an autonomy-supportive vs controlling way) in the prediction of adolescent motivation (ie, internalization or defiance) to adhere to self-management for type 1 diabetes. METHODS: Structural Equation Modeling was used in a cross-sectional, multi-informant study of 129 adolescents (Mage = 14.43; 54.4% girls), 110 mothers, and 98 fathers. Adolescents reported on self-motivation, treatment adherence, and parental expectations and communication styles; parents reported on their own expectations, communication style, and perceptions of adolescent treatment adherence. Medical record review provided HbA1c values. RESULTS: Across adolescent and parent reports, parental communication of diabetes-specific expectations and an autonomy-supportive style of communicating expectations related positively to adolescents' internalization of diabetes self-management and negatively to defiance against diabetes self-management. In contrast, a controlling parental communication style showed the opposite patterns of associations. Higher adolescent defiance was related to poorer treatment adherence and worse glycemic control. CONCLUSIONS: Parental communication styles related to adolescent motivation, which in turn, related to adolescent treatment adherence and glycemic control. Future longitudinal research can address the long-term impact of both maternal and paternal communication styles on adolescent motivation to adhere to treatment and their subsequent glycemic control. ispartof: PEDIATRIC DIABETES vol:20 issue:7 pages:1025-1034 ispartof: location:Denmark status: published

Aims To use a three-phase process to develop and validate new self-report measures of diabetes-specific health-related quality of life (HRQOL) for adults with type 1 diabetes. We report on four versions of the Type 1 Diabetes and Life (T1DAL) measure for people age 18–25, 26–45, 46–60, and over 60 years. Methods We first conducted qualitative interviews to guide measure creation, then piloted the draft measures. We evaluated psychometric properties at six T1D Exchange Clinic Network sites via completion of T1DAL and validated measures of related constructs. Participants completed the T1DAL again in 4–6 weeks. We used psychometric data to reduce each measure to 23–27 items in length. Finally, we obtained participant feedback on the final measures. Results The T1DAL-Adult measures demonstrated good internal consistency (α = 0.85–0.88) and test–retest reliability (r = 0.77–0.87). Significant correlations with measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, self-management, and glycemic control demonstrated validity. Factor analyses yielded 4–5 subscales per measure. Participants were satisfied with the final measures and reported they took 5–10 min to complete. Conclusions The strong psychometric properties of the newly developed self-report T1DAL measures for adults with type 1 diabetes make them appropriate for use in clinical research and care.

Background Adolescents with type 1 diabetes are at an increased risk of disturbed eating behaviors (DEBs). Objective The aims of this study are to (i) explore the prevalence of DEBs and associated ‘yellow flags’, and (ii) establish concordance between adolescents–parents and adolescents–clinicians with respect to DEBs. Methods Adolescents (11–16 yr) and parents completed questionnaires. A stepwise approach was used to assess DEBs: only adolescents whose answers raised psychological yellow flags for DEBs completed the Diabetes Eating Problems Scale – Revised and questions from the AHEAD study. Parents and clinicians shared their observations regarding possible DEBs. Kruskal–Wallis tests, post hoc Mann–Whitney U test, and chi-squared tests were utilized to examine clinical yellow flags. Cohen's kappa was used to assess concordance. Results Of 103 adolescents participated (51.5% girls), answers of 47 (46.5%) raised psychological yellow flags, indicating body and weight concerns. A total of 8% scored above cut-off for DEBs. Clinical yellow flags were elevated glycated hemoglobin A1c (p = 0.004), older age (p = 0.034), dieting frequency (p = 0.001), reduced quality of life (p = 0.007), less diabetes self-confidence (p = 0.015), worsened diabetes management (p

OBJECTIVE To establish the effectiveness of a brief, partly web-based group intervention, HypoAware, in patients with problematic hypoglycemia, in terms of the reduction of severe hypoglycemic episodes, impaired hypoglycemia awareness, and worries. RESEARCH DESIGN AND METHODS A two-arm, cluster randomized controlled trial was conducted in insulin-treated patients with problematic hypoglycemia in eight Dutch clinics comparing HypoAware with care as usual. Primary outcomes included self-reported severe hypoglycemia, impaired hypoglycemia awareness (Gold score), and worries and distress about hypoglycemia (Hypoglycemia Fear Survey-II/Problem Areas In Diabetes scale hypo-item), assessed at baseline, and at 2, 4, and 6 months of follow-up. We used t tests, nonparametric tests, and intention-to-treat generalized estimation equation (GEE) analyses with linear, logistic, and Poisson or negative binomial models. RESULTS We enrolled 137 participants. Adjusted GEE analyses over four time points showed a nonsignificant 33% fewer episodes of severe hypoglycemia in the HypoAware group compared with the control group (relative risk [RR] 0.67 [95% CI 0.39–1.16], P = 0.150); a significant reduced odds of impaired awareness (odds ratio 0.38 [95% CI 0.15–0.95], P = 0.038), a trend toward 20% fewer worries about hypoglycemia (RR 0.80 [95% CI 0.64–1.01], P = 0.059), and a significant 30% less hypo-distress (RR 0.70 [95% CI 0.56–0.88], P = 0.002). Over the 6-month study duration, participants experienced a median of 2.5 events of severe hypoglycemia (interquartile range [IQR] 1–10) in the control condition versus 1 event (IQR 0–6.5) in the HypoAware group (P = 0.030). There was no significant change in HbA1c level within and between both groups. CONCLUSIONS HypoAware resulted in fewer severe hypoglycemic episodes, significantly improved hypoglycemia awareness, and less hypo-distress in comparison with usual care, and deserves further dissemination.

Developmental shifts during early adolescence relate to type 1 diabetes (T1D) self-management, increased risk of emotional distress, and worsening health status. Less is known about positive experiences related to T1D. This study evaluated associations of positive well-being (PWB) with diabetes burden, self-management, and glycemic control. Youth ( N = 55, age = 12-13 years; [Formula: see text] age = 12.75 + 0.56 years, 50.9% male, 38.2% non-Caucasian) reported PWB, depressive symptoms, and diabetes burden. Parents reported on overall T1D adherence. Adherence behaviors and glycemic control were assessed objectively. Higher PWB correlated with lower depressive symptoms ( rs = −.45), less diabetes burden ( rs = −.48), and better glycemic control ( rs = −.43), all p < .01. When controlling for diabetes duration, higher PWB correlated with lower depressive symptoms and better glycemic control. PWB was not related to demographics or adherence. Initial exploration suggests PWB is related to key diabetes constructs, and maybe valuable to consider along with efforts to support youth with T1D during a vulnerable developmental period.

ObjectiveInsulin glargine 300 (Gla-300) provides less hypoglycemia risk and more flexibility in injection time. The extent to which these effects translate into improved patient-reported outcomes (PROs) is unknown, and is the subject of this observational study.Research design and methodsAdults with type 2 diabetes treated with basal insulin for at least 6 months initiating Gla-300 were included. Data were collected at baseline (start Gla-300) and at 3-month and 6-month follow-up. Patients and physicians gave reasons for switching to Gla-300 at baseline and the extent to which Gla-300 fulfilled their expectations at 6 months. Mixed model analyses examined PRO changes over time, with emotional well-being (WHO-5 Well-Being Index) as the primary outcome. The secondary outcomes were hypoglycemia incidence, hemoglobin A1c (HbA1c), hypoglycemia worries (worry subscale of the Hypoglycemia Fear Survey), diabetes distress (short form of the Dutch version of the Problem Areas In Diabetes Scale), diabetes medication convenience (Diabetes Medication System Rating Questionnaire (DMSRQ)), sleep quality and duration (Pittsburgh Sleep Quality Index), and adherence (Summary of Diabetes Self-Care Activities).Results162 patients participated: 53.70% were men, the mean age was 65.54 years (9.05), baseline mean HbA1c was 7.87% (1.15) (62.48 mmol/mol (12.61)), and mean diabetes duration was 15.14 years (6.65). Mean WHO-5 Well-Being Index scores improved non-significantly from 61.94 (19.52) at baseline (T0) to 63.83 (19.67) at 6 months (T2). Mean DMSRQ scores improved significantly from 32.96 (9.02) (T0) to 36.70 (8.85) (T2) (pConclusionIn a relatively well-controlled sample of adults with type 2 diabetes, switching to Gla-300 improves diabetes medication convenience.

Insulin glargine-300 (U-300) provides a flatter and more prolonged profile than U-100, with less risk of hypoglycemia. Real-world evidence of the effect of U-300 on Patient Reported Outcomes (PROs) is lacking. Adults with type 2 diabetes (T2DM) using insulin for ≥6 months and initiating U-300 were included. Data were collected at baseline (start U-300; T0)), 3 (T1) and 6 months (T2). Intention-to-treat mixed model analyses examined change over time in HbA1c, self-reported hypoglycemia and PROs: emotional well-being (WHO-5), hypoglycemia worries (HFS-W), diabetes distress (PAID-SF), diabetes medication convenience (DMSRQ), sleep quality and duration (PSQI), and adherence (1 item SDSCA). Also, the extent to which U-300 fulfilled its expectations was measured at T2 both in physicians and patients. P-value threshold was set at .for the WHO-5 and .01 for other outcomes. In total, 162 persons with T2DM participated: 53.7% men, mean age 64.54 years (9.05), baseline mean HbA1c 62.48 mmol/mol (12.61). Hypoglycemia incidence decreased non-significantly: for symptomatic events from 31.5% (T0) to 24.8% (T2), nocturnal events from 6.8% (T0) to 4.1% (T2), severe events from 4.9% (T0) to 0.0% (T2). HbA1c trended towards a decrease to 60.32 mmol/mol (12.09) (T2). Mean WHO-5 scores trended towards improvement, from 61.73 (T0) to 63.93 (T2). Mean DMSRQ scores improved significantly from 32.70 (T0) to 35.80 (T1) (beta T0-T1 = 3.28; p Disclosure T.H. Wieringa: Other Relationship; Self; Sanofi. M. de Wit: Advisory Panel; Self; Sanofi.J. Twisk: None.F.J. Snoek: None.

OBJECTIVE: Successful self-management of type 1 diabetes requires cognitive skills such as executive functioning (EF). In the transition to adolescence, youth take over responsibility for diabetes management. We set out to test: 1) the association between EF and glycemic control over time and 2) whether this association was moderated by: a) youth, shared, or parent responsibility for diabetes management and b) youth's age. RESEARCH DESIGN AND METHODS: Within the Diabetes IN DevelOpment study (DINO), parents of youth with type 1 diabetes (8-15 years at baseline; N = 174) completed a yearly assessment over 4 years. Glycemic control (HbA1c) was derived from hospital charts. Youth's EF was measured using the Behavior Rating Inventory of Executive Functioning (BRIEF)-parent report. The Diabetes Family Responsibility Questionnaire (DFRQ)-parent report was used to assess diabetes responsibility (youth, shared, and parent). Linear generalized estimating equations were used to analyze data including youth's sex, age, and age of diabetes onset as covariates. RESULTS: Relatively more EF problems are significantly associated with higher HbA1c over time (β = 0.190; P = 0.002). More EF problems in combination with less youth responsibility (β = 0.501; P = 0.048) or more parental responsibility (β = -0.767; P = 0.006) are significantly associated with better glycemic control over time. Only age significantly moderates the relationship among EF problems, shared responsibility, and glycemic control (β = -0.024; P = 0.019). CONCLUSIONS: Poorer EF is associated with worse glycemic control over time, and this association is moderated by responsibility for diabetes management tasks. This points to the importance of EF when youth take over responsibility for diabetes management in order to achieve glycemic control.

Thanks to Drs. Kalra, Balhara, Mezuk, Pouwer, and Campbell and Ms. Macdonald for their careful consideration (1–3) of the first American Diabetes Association (ADA) psychosocial guidelines Position Statement (4). Kalra and Balhara (1) note the overlaps and differences in the content of the ADA and Indian position statements, with particular emphasis on the cultural appropriateness and specificity of recommendations. Mezuk and Pouwer (2) question the need for routine screening for depression in persons with impaired glucose metabolism and undiagnosed diabetes based on meta-analytic results (5) and note the need to address disparities in diabetes burden and quality of care. They further suggest the need for action steps for practitioners once psychosocial issues are identified that impact health outcomes. These concerns are echoed by Macdonald and Campbell (3) when identifying that emphasis on compliance can cause blame to be placed on patients through misguided interpretation of the patient-centered paradigm. They suggest that this might be avoided through “long-term” care, by which they appear to mean the relationship formed through long-term follow-through by a consistent care provider. These authors identify social issues that are not explicitly addressed in the ADA Position Statement: barriers to getting married, gender-based issues, geographically based management challenges, culturally specific intervention strategies for increasing well-being, disparities in burden and quality of care for …

ObjectiveTo determine the health-related quality of life (HRQOL) of overweight and obese multi-ethnic children compared with normal-weight children; and to investigate differences in HRQOL between self- and parent-proxy reports and ethnic groups.DesignProspective cross-sectional study.SettingOut-patient clinic where children and their parents filled out a validated HRQOL questionnaire (KIDSCREEN-52) and height, weight, waist circumference and fat percentage were measured.SubjectsOverweight and obese children, aged 8–18 years (mean BMIZ-score 3·2 (sd0·6)), from the obesity out-patient clinic.ResultsThree hundred and eight self- and 213 parent-proxy reported questionnaires were completed. Global HRQOL and the Physical Wellbeing, Moods & Emotions and Self-Perception subscales were markedly reduced in our multi-ethnic obese cohort, relative to the Dutch reference values. Parent proxies reported significantly lower on the global HRQOL and the Physical Wellbeing, Moods & Emotions and Bullying subscales. In Caucasian children, multivariate analyses showed that BMI was associated with the quality-of-life subscales Moods & Emotions, Self-Perception and Bullying.ConclusionsHRQOL was markedly reduced in our multi-ethnic overweight and obese out-patient clinic cohort, with significantly lower parent-proxy scores compared with self-reported scores. We believe intervention programmes aiming to improve HRQOL should be directed to both parents and children, while ethnic-specific programmes to enhance HRQOL seem of less importance.

BackgroundStrict glycemic control during adolescence decreases the risk of developing complications later in life, even if this level of control is not maintained afterwards. However, the majority of adolescents with type 1 diabetes (T1D) are in poor control and so far medical or psychological interventions have shown limited success. Adolescence is characterized by major biological, psychosocial, cognitive and parent–child relationship changes and the complex interaction between these developmental trajectories, and its impact on health outcomes is still poorly understood. A specific topic of interest in this context is the timing of diagnosis. The longitudinal study DINO (Diabetes IN develOpment) aims to examine:1) If and how the onset of T1D before vs. during puberty results in different outcomes of glycemic control, self-management, psychological functioning and diabetes-related quality of life.2) The timing of onset of disturbed eating behavior, its risk factors and its prospective course in relation to glycemic and psychological consequences.3) If and how the onset of T1D before vs. during puberty results in different family functioning and parental well-being.4) If and how the cognitive development of youth with T1D relates to glycemic control and diabetes self-management.Methods/designDINO, a longitudinal multi-center cohort study is conducted in youth with T1D in the age range 8–15 years at baseline. Participants will be divided into two subgroups: pre-pubertal and pubertal. Both groups will be followed for 3 years with assessments based on a bio-psychosocial model of diabetes, scheduled at baseline, 12 months, 24 months and 36 months examining the biological, psychosocial -including disturbed eating behaviors- and cognitive development, family functioning and parental well-being.DiscussionA better understanding of how the different trajectories affect one another will help to gain insight in the protective and risk factors for glycemic outcomes and in who needs which support at what moment in time. First results are expected in 2016.Keywords: Type 1 diabetes, Development, Youth, Quality of life, Well-being, Adolescence, Cognition, HbA1c, Psychosocial, Parents

Objective Monitoring quality of life (QoL) improves well-being and care satisfaction of adolescents with type 1 diabetes. We set out to evaluate the implementation of the program DAWN (Diabetes Attitudes Wishes and Needs) MIND-Youth (Monitoring Individual Needs in Young People With Diabetes) (DM-Y), in which Dutch adolescents' QoL is assessed with the MIND Youth Questionnaire (MY-Q) and its outcomes are discussed. Successful implementation of DM-Y warrants close study of experienced barriers and facilitators as experienced by diabetes care teams as well as adolescents and parents. Methods The study was conducted in 11 self-selected Dutch pediatric diabetes clinics. A mixed methods approach was used. Ten diabetes teams (26 members) were interviewed; 36 team members, 29 adolescents, and 66 parents completed an online survey. Results Two of 10 teams successfully implemented DM-Y. Whereas 92% of teams valued DM-Y as a useful addition to routine care, most clinics were not able to continue because of logistical problems (lack of time and manpower). Still, all teams had the ambition to make DM-Y integral part of routine care in the nearby future. Seventy-nine percentage of the parents and 41% of the adolescents appreciated the usage of MY-Q, same percentage of adolescents neutral. Conclusions DM-Y is highly appreciated by teams, as well as adolescents and parents, but for most clinics it is difficult to implement. More effort should be paid to resolve logistic problems in order to facilitate dissemination of DM-Y in care nationwide.

ObjectivesTo test the efficacy of a low-intensive lifestyle education program (DiAlert) for overweight first degree relatives of type 2 diabetes patients aimed at reducing diabetes risk.MethodsOverweight first degree relatives of type 2 diabetes patients were randomly assigned to the DiAlert intervention (N = 45) or control group who received leaflets (N = 51). DiAlert consists of two group sessions and newsletters. Assessments were scheduled at baseline, three and nine months, with weight loss as primary outcome. Secondary outcomes included anthropometric, metabolic, behavioral and psychological measures. Comparisons were made over time and between groups.ResultsBoth groups showed modest weight loss with no difference between randomization groups. However, after DiAlert significantly more participants lost 5% of their weight compared to controls (P = 0.03). Significant improvement of waist circumference sustained after 9 months in the intervention group (intervention: −4.33 cm, P < 0.01/control: −1.25 cm, P = 0.08). Systolic blood pressure improved within the intervention group (intervention: −8.77 mmHg, P < 0.01/control: −1.03 mmHg, P = 0.60). No effect was observed for biomedical and psychosocial outcomes.ConclusionsOur low-intensive structured lifestyle education program helps overweight relatives to improve waist circumference and supports relevant weight loss.Practice implicationsThe family approach provides opportunities to reach and engage relatives at risk in diabetes prevention education.

Objective. Managing type 1 diabetes (T1D) requires the ability to make complex and critical decisions regarding treatment, to execute complex tasks accurately, and to make adjustments when problems arise. This requires effective neuropsychological competences of patients and their families, especially in the domain of executive functioning (EF): the ability to self-monitor, plan, solve problems, and set priorities. Previous research focused mainly on child EF, neglecting the impact of parental EF. This study included both mothers and fathers and examined associations between child and parental EF and treatment adherence to T1D in a broad age range of patients. Methods. Parents of 270 patients (6-18 years) with T1D (mean age 12.7yrs; 52.6% female) were included. Mothers (N= 232) and fathers (N=168) completed questionnaires on child and parental EF and on treatment adherence. Analyses examined the associations linking child and parental EF to treatment adherence and glycemic control (and potential moderation effects in these associations) using hierarchical linear regression. Results. Child EF problems were negatively associated with treatment adherence. As an indication of moderation, this effect was stronger in older children. Better treatment adherence and glycemic control were reported when both child and parent showed less EF problems. Effects were more pronounced in mothers than in fathers. Conclusions. This study demonstrated a significant interplay between child and parental EF in the association with treatment adherence and glycemic control. Researchers and clinicians should remain attentive toward the role of neuropsychological concepts such as EF. Implementation in clinical practice seems meaningful. ispartof: Pediatric Diabetes vol:19 issue:3 pages:520-526 ispartof: location:Denmark status: published

Objective. To evaluate (1) the longitudinal relationship between parental well-being and glycemic control in youth with type 1 diabetes and (2) if youth’s problem behavior, diabetes parenting behavior, and parental diabetes-distress influence this relationship. Research Design and Methods. Parents of youth 8–15 yrs (at baseline) (N=174) participating in the DINO study completed questionnaires at three time waves (1 yr interval). Using generalized estimating equations, the relationship between parental well-being (WHO-5) and youth’s HbA1c was examined. Second, relationships between WHO-5, Strength and Difficulties Questionnaire (SDQ), Diabetes Family Behavior Checklist (DFBC), Problem Areas In Diabetes-Parent Revised (PAID-Pr) scores, and HbA1c were analyzed. Results. Low well-being was reported by 32% of parents. No relationship was found between parents’ WHO-5 scores and youth’s HbA1c (β=−0.052, p=0.650). WHO-5 related to SDQ (β=−0.219, p<0.01), DFBC unsupportive scale (β=−0.174, p<0.01), and PAID-Pr (β=−0.666, p<0.01). Both DFBC scales (supportive β=−0.259, p=0.01; unsupportive β=0.383, p=0.017), PAID-Pr (β=0.276, p<0.01), and SDQ (β=0.424, p<0.01) related to HbA1c. Conclusions. Over time, reduced parental well-being relates to increased problem behavior in youth, unsupportive parenting, and parental distress, which negatively associate with HbA1c. More unsupportive diabetes parenting and distress relate to youth’s problem behavior.