The diabetes body project: Study protocol of a multi-site trial of a virtually delivered eating disorder prevention program for young women with type 1 diabetes.

AIM: Young women with type 1 diabetes are a high-risk population for eating disorders (ED). Prevention programs are lacking. In young women without diabetes, the Body Project has produced reductions in ED risk factors, ED symptoms and future ED onset. Therefore, the Body Project was adapted to type 1 diabetes, the Diabetes Body Project (DBP). In this protocol, we describe the multi-site randomized controlled trial (RCT) to evaluate efficacy of the DBP. METHODS: This is an ongoing RCT with four sites (Europe and US). In total 280, 14-35 year-old, women with type 1 diabetes ≥1 year and some level of body image concerns will be recruited in 2023. Participants are randomized to either virtual DBP groups or an educational control. The study constitutes 5 measurement points distributed over 2 years. The primary aim is to test if DBP will produce significantly greater reductions in ED behaviours, ED symptoms and future ED onset. The secondary aim is to test if DBP has significantly greater improvements in diabetes distress, quality of life and glycaemic outcomes. RESULTS: We expect that DBP will be more efficacious in reducing ED behaviours, ED symptoms and ED onset compared to the control condition. Additionally, we hope to gain new knowledge on how DBP may affect diabetes-related outcomes. CONCLUSIONS: If DBP proves efficacious, it has potential for immediate, clinical implementation at low-cost and may contribute to broad prevention of future ED onset among young women with type 1 diabetes. GOV IDENTIFIER: NCT05399446.

A Self-Guided Web-Based App (MyDiaMate) for Enhancing Mental Health in Adults With Type 1 Diabetes: Insights From a Real-World Study in the Netherlands.

BACKGROUND: MyDiaMate is a web-based intervention specifically designed for adults with type 1 diabetes (T1D) that aims to help them improve and maintain their mental health. Prior pilot-testing of MyDiaMate verified its acceptability, feasibility, and usability. OBJECTIVE: This study aimed to investigate the real-world uptake and usage of MyDiaMate in the Netherlands. METHODS: Between March 2021 and December 2022, MyDiaMate was made freely available to Dutch adults with T1D. Usage (participation and completion rates of the modules) was tracked using log data. Users could volunteer to participate in the user profile study, which required filling out a set of baseline questionnaires. The usage of study participants was examined separately for participants scoring above and below the cutoffs of the "Problem Areas in Diabetes" (PAID-11) questionnaire (diabetes distress), the "World Health Organization Well-being Index" (WHO-5) questionnaire (emotional well-being), and the fatigue severity subscale of the "Checklist Individual Strength" (CIS) questionnaire (fatigue). Two months after creating an account, study participants received an evaluation questionnaire to provide us with feedback. RESULTS: In total, 1008 adults created a MyDiaMate account, of whom 343 (34%) participated in the user profile study. The mean age was 43 (SD 14.9; 18-76) years. Most participants were female (n=217, 63.3%) and higher educated (n=198, 57.6%). The majority had been living with T1D for over 5 years (n=241, 73.5%). Of the study participants, 59.1% (n=199) of them reported low emotional well-being (WHO-5 score≤50), 70.9% (n=239) of them reported elevated diabetes distress (PAID-11 score≥18), and 52.4% (n=178) of them reported severe fatigue (CIS score≥35). Participation rates varied between 9.5% (n=19) for social environment to 100% (n=726) for diabetes in balance, which opened by default. Completion rates ranged from 4.3% (n=1) for energy, an extensive cognitive behavioral therapy module, to 68.6% (n=24) for the shorter module on hypos. There were no differences in terms of participation and completion rates of the modules between study participants with a more severe profile, that is, lower emotional well-being, greater diabetes distress, or more fatigue symptoms, and those with a less severe profile. Further, no technical problems were reported, and various suggestions were made by study participants to improve the application, suggesting a need for more personalization. CONCLUSIONS: Data from this naturalistic study demonstrated the potential of MyDiaMate as a self-help tool for adults with T1D, supplementary to ongoing diabetes care, to improve healthy coping with diabetes and mental health. Future research is needed to explore engagement strategies and test the efficacy of MyDiaMate in a randomized controlled trial.

Psychometric properties of the Diabetes Eating Problem Survey-Revised among Dutch adults with type 1 diabetes and implications for clinical use.

AIMS: Disordered eating behaviour (DEB) in people with type 1 diabetes (T1D) can be screened with the Diabetes Eating Problem Survey-Revised (DEPS-R). This study aimed to investigate the psychometric properties of the DEPS-R among Dutch adults with T1D and to explore the individual items alongside the standard cut-off score of ≥20 for clinical use. METHODS: The construct validity of the DEPS-R was assessed with an exploratory factor analysis, through principal axis factoring and with Spearman correlations between clinical variables and the DEPS-R. Backward logistic regression identified clinical predictors for DEPS-R scores above the cut-off. DEPS-R item responses were summarized with frequencies, means and standard deviations. RESULTS: Participants were 145 adults with T1D, of whom 79.3% were women and 35.9% presented with DEB based on the cut-off. A single-factor solution of the DEPS-R showed good internal consistency, while a three-factor solution showed acceptable to good internal consistency within the factors. A younger age, a higher BMI and more diabetes distress were predictors for a DEPS-R cut-off score of ≥20. Clinically relevant items were identified that contributed minimally to the DEPS-R score. CONCLUSIONS: This study supports a single-factor and a three-factor structure of the DEPS-R while also suggesting an item-specific or factor-specific approach in clinical practice.

Bringing an end to diabetes stigma and discrimination: an international consensus statement on evidence and recommendations.

People with diabetes often encounter stigma (ie, negative social judgments, stereotypes, prejudice), which can adversely affect emotional, mental, and physical health; self-care, access to optimal health care; and social and professional opportunities. To accelerate an end to diabetes stigma and discrimination, an international multidisciplinary expert panel (n=51 members, from 18 countries) conducted rapid reviews and participated in a three-round Delphi survey process. We achieved consensus on 25 statements of evidence and 24 statements of recommendations. The consensus is that diabetes stigma is driven primarily by blame, perceptions of burden or sickness, invisibility, and fear or disgust. On average, four in five adults with diabetes experience diabetes stigma and one in five experience discrimination (ie, unfair and prejudicial treatment) due to diabetes, such as in health care, education, and employment. Diabetes stigma and discrimination are harmful, unacceptable, unethical, and counterproductive. Collective leadership is needed to proactively challenge, and bring an end to, diabetes stigma and discrimination. Consequently, we achieved unanimous consensus on a pledge to end diabetes stigma and discrimination.

The relationship between emotional self-awareness, emotion regulation, and diabetes distress among Italian and Dutch adults with type 1 diabetes.

Objective: Evidence suggests that many adults with type 1 diabetes (T1D) experience clinically relevant levels of diabetes distress, indicating coping difficulties. Studies have primarily focused on emotion regulation as a possible construct to be addressed in psychological interventions to alleviate diabetes distress. This study extends the literature by investigating the cross-sectional association between emotion regulation, diabetes distress and the construct of emotional self-awareness as an additional variable to be considered in potentially reducing diabetes distress. Methods: Via an online survey, data was collected on emotional self-awareness dimensions (attention to feelings, clarity of feelings), emotion regulation strategies (cognitive reappraisal, expressive suppression, mood repair) and diabetes distress, along with self-reported clinical and sociodemographic information. Multiple linear regression with stepwise backward method was used to examine associations, controlling for country. Results: N = 262 Italian and Dutch adults with T1D (80.5% women, M = 38.12 years, SD = 12.14) participated. Clarity of feelings was significantly negatively associated with diabetes distress, resulting in a medium effect size (ß = -0.22, p < 0.001). Likewise, mood repair was negatively related to diabetes distress, showing a small effect size (ß = -0.26, p < 0.001). Conclusion: These findings shed light on the importance of a dimension of emotional self-awareness, namely clarity of feelings. This represents the ability to identify one's emotional states and discriminate between them. Thus, it should be considered in psychological interventions, such as mentalization-based treatment, that might contribute to alleviating T1D-related distress.

Glucose variability and mood in people with type 1 diabetes using ecological momentary assessment.

OBJECTIVE: Mood fluctuations related to blood glucose excursions are a commonly reported source of diabetes-distress, but research is scarce. We aimed to assess the relationship between real-time glucose variability and mood in adults with type 1 diabetes (T1D) using ecological momentary assessments. METHODS: In this prospective observational study, participants wore a masked continuous glucose monitor and received prompts on their smartphone 6 times a day to answer questions about their current mood (Profile Of Mood States (POMS)-SF (dimensions: Anxiety, Depressive symptoms, Anger, Fatigue, Vigor)) for 14 days. Mixed model analyses examined associations over time between daily Coefficient of Variation (CV) of blood glucose and mean and variability (CV) of POMS scores. Further, within-person differences in sleep and nocturnal hypoglycemia were explored. RESULTS: 18 people with T1D (10 female, mean age 44.3 years) participated. A total of 264 out of 367 days (70.2%) could be included in the analyses. No overall significant associations were found between CV of blood glucose and mean and CV of POMS scores, however, nocturnal hypoglycemia moderated the associations between CV of blood glucose and POMS scales (mean Fatigue Estimate 1.998, p < .006, mean Vigor Estimate -3.308, p < .001; CV Anger Estimate 0.731p = 0.02, CV Vigor Estimate -0.525, p = .006). CONCLUSION: We found no overall relationship between real-time glycemic variability and mood per day. Further research into within-person differences such as sleep and nocturnal hypoglycemia is warranted.

Observing, 'doing' and 'making' gender in Dutch paediatric type 1 diabetes care, at home and in the clinic: Multiple-stakeholder perspectives.

AIM: To investigate the perspectives of Dutch care professionals, parents and experts by experience on gender dynamics in paediatric type 1 diabetes care. DESIGN: Qualitative research design. METHODS: Fifteen semi-structured interviews were held with care professionals, supplemented by two focus groups with parents of children with diabetes (n = 12 parents) and three semi-structured interviews with two experts by experience and a mother. Two respondent validation interviews were conducted, one with two care professionals and one with an expert by experience. Participant observations were conducted at three clinics, a diabetes sports day, weekend for young people and their families, and a high-school. An inductive framework analysis was done, informed by relational theory on gender. RESULTS: Care professionals 'did' and 'made' gender differences together with young people, manifesting as communicative difficulties, in particular between female care professionals and young boys. Boys were considered less skilled in articulating their needs compared to girls. At home, care professionals and parents observed, 'did' and 'made' gender differences by perpetuating gendered divisions of labour. As traditional caretakers, mothers risk focusing excessively on the diabetes of their child whilst fathers remained more at a distance. CONCLUSION: Gender patterns have negative implications on those involved in paediatric type 1 diabetes. Leaving tacit the gendered communicative issues across child-parent and child-care professional dyads, can sustain invisible friction in a care system that normatively expects verbal participation and increased self-management. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: Findings may encourage care professionals and parents to engage with the potential impact of gender dynamics on diabetes practices. Incorporating these dynamics as conversational tools would contribute to improving type 1 diabetes care for young people.

Associations between disordered eating behaviour, diabetes distress and emotion regulation strategies in adults with type 1 diabetes: Results from a Dutch-Italian cross-sectional study.

AIMS: Disordered eating behaviour (DEB) and diabetes distress are prevalent in adults with type 1 diabetes (T1D). Emotion regulation strategies, such as cognitive reappraisal and expressive suppression, are associated with DEB and managing stress in general. Here we examine the associations between DEB, diabetes distress, and emotion regulation strategies in the context of T1D. METHODS: Adults with T1D in The Netherlands and Italy completed an online survey, covering DEB (DEPS-R), diabetes distress (PAID-5), and emotion regulation strategies (ERQ). Associations between DEB, diabetes distress, and emotion regulation strategies were examined using path analysis. RESULTS: N = 291 participants completed the survey (78.9% women, 39 ± 13 years, HbA1c : 55 ± 16 mmol/mol (7.2% [3.6%]); TIR: 66% ± 25). N = 79 participants (27.1%) reported DEB (DEPS-R ≥ 20) and n = 159 participants (54.6%) reported elevated diabetes distress (PAID-5 ≥ 8). The path analysis, with small-to-medium effect sizes, revealed that more diabetes distress was associated with more DEB (ß = 0.23, 95% CI [0.13, 0.34]). Less diabetes distress was associated with more use of cognitive reappraisal (ß = -0.24, 95% CI [-0.36, -0.12]). More DEB was associated with more use of expressive suppression (ß = 0.14, 95% CI [0.04, 0.24]). CONCLUSIONS: This cross-sectional study suggests an association between DEB and diabetes distress, between cognitive reappraisal and less diabetes distress and between expressive suppression and more DEB. The results suggest that it may prove beneficial to prioritize strengthening emotion regulation strategies in interventions for people with T1D and DEB. Future research should help clarify causality with regard to emotion regulation and DEB in adults with T1D.

Improved Effectiveness of Immediate Continuous Glucose Monitoring in Hypoglycemia-Prone People with Type 1 Diabetes Compared with Hypoglycemia-Focused Psychoeducation Following a Previous Structured Education: A Randomized Controlled Trial.

Objective: Stepped-care has been suggested in the management of patients with problematic hypoglycemia and impaired awareness of hypoglycemia (IAH), initially with psychoeducational programs based on blood glucose awareness training, progressing to diabetes technology in those with persisting need. We examined the clinical effectiveness of stepped-care starting with HypoAware and adding continuous glucose monitoring (CGM) as needed, versus immediate CGM in type 1 diabetes patients with problematic hypoglycemia despite previous structured education in insulin adjustment. Research Design and Methods: A randomized controlled trial (N = 52, mean age 53, 56% females). The stepped-care group attended HypoAware. If a severe hypoglycemic event (SHE) had occurred or IAH was still present after 6 months, CGM was initiated. The control group started immediate CGM. Primary endpoint was the number of participants with self-reported SHE. Secondary outcomes, evaluated at 6 and 12 months, were glycated hemoglobin (HbA1c), the number of participants with IAH time below range (TBR; <54 mg/dL), and patient-reported outcomes (PROs). Results: At 6 months, the number of patients reporting SHE had decreased significantly more in the CGM group: -39% (P < 0.05). HbA1c decreased more in the CGM group (-0.47 percentage-points, P < 0.05). IAH was restored in 31% of patients in both groups. TBR (<54 mg/dL) was lower in the CGM group (-2.4 percentage-points, P < 0.05). In the stepped-care group, 93% started CGM/intermittently scanned CGM. At 12 months, the number of patients reporting SHE was still higher in the stepped-care group. No differences were found in PROs. Conclusions: Immediate start of CGM is more effective than a hypoglycemia-focused reeducation program in reducing SHE risk and attaining glycemic targets in individuals with problematic hypoglycemia and IAH despite previous education in insulin dose adjustment. Trial registration: Netherlands Trial Register, NL64474.029.18.

The handling of missing data in trial-based economic evaluations: should data be multiply imputed prior to longitudinal linear mixed-model analyses?

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.

A personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with type 2 diabetes mellitus, the INTENSE study: study protocol for a randomised controlled trial.

BACKGROUND: Medication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus (T2DM). Interventions have previously been developed to improve medication adherence, but inconsistent outcomes have been reported. A potential explanation for this inconsistency is a 'one size fits all' approach, with interventions not tailored to the needs and preferences of individuals. Therefore, the aim of this study is to evaluate the effectiveness of a personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with T2DM. METHODS: A parallel-group randomised controlled trial will be conducted in 40-50 community pharmacies in the Netherlands and the United Kingdom (UK). A total of 300 participants will be included and followed up for a period of 6 months. Participants will be people with T2DM identified as non-adherent to oral antidiabetic and/or antihypertensive medication, aged 35-75 years and mobile phone users. The intervention group will receive a personalised intervention programme that is based on one or more of the participants' pre-defined non-adherence profile(s), namely (I) Knowledge and perceptions, (II) Practical problems, (III) Side effects and (IV) Negative mood and beliefs. The intervention comprises of one or more supporting modules, namely (I) Brief messaging, (II) Clinical medication review, (III) Medication schedule, (IV) Reminding messaging, (V) Medication dispensing systems, (VI) Smart messaging, (VII) Referral to general practitioner and (VIII) Unguided web-based Self Help Application for low mood. The control group will receive usual care including access to a publicly available informative diabetes website. The primary study outcome is medication adherence measured with a telephone pill count. Secondary outcomes are systolic blood pressure, HbA1c level, self-reported medication adherence, attitude and beliefs toward medication, satisfaction with diabetes treatment, health status and medical consumption and productivity cost. In addition, a process evaluation will be undertaken to establish the fidelity, reach and the extent to which intervention delivery is normalised in the daily practice of community pharmacy teams. DISCUSSION: The study can lead to a personalised intervention programme that improves medication adherence in people with T2DM that are non-adherent to oral antidiabetic and/or antihypertensive medication. TRIAL REGISTRATION: Dutch Trial Register, Trial NL8747 , registered 02 July, 2020; ISRCTN Registry, ISRCTN36009809 , registered 05 February, 2020.

Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review.

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. 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.

The role of mental disorders in precision medicine for diabetes: a narrative review.

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.

Feasibility and user experience of the unguided web-based self-help app 'MyDiaMate' aimed to prevent and reduce psychological distress and fatigue in adults with diabetes.

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.

All together: Integrated care for youth with type 1 diabetes.

OBJECTIVE: 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. RESEARCH DESIGN AND 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 three 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 adolescents 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.

Health-related quality of life in parents and partners of people with type 1 diabetes: Development and validation of type 1 diabetes and life (T1DAL) measures.

INTRODUCTION: Despite the significant impact of type 1 diabetes (T1D) on family, few instruments are available to assess health-related quality of life (HRQOL) among family members of people with T1D. This study aimed to develop and evaluate the psychometric properties of new measures of diabetes-specific HRQOL for parents and partners of people with T1D. We report on the multistep development and validation process for the self-report Type 1 Diabetes and Life (T1DAL) measures, with versions for parents of youth age <8, 8-11, 12-17, and 18-25 years, and for partners of people age ≥18 years with T1D. METHOD: First, we conducted qualitative interviews (total parents/partners n = 38) to develop draft measures and piloted them (total n = 20). Next, we tested the measures' psychometric properties. Participants (total across versions n = 813) at six T1D Exchange Clinic Network sites completed the appropriate T1DAL measure and validated measures of related constructs. We then reduced each T1DAL measure to 20-30 items in length based on psychometric data and participant feedback. Eleven participants reviewed the final measures via cognitive debriefing. RESULTS: The T1DAL measures for parents and partners demonstrated good internal consistency (α = .80-.88) and test-retest reliability (r = .73-.86). Correlations with measures of general quality of life, generic and diabetes-specific HRQOL, and diabetes burden demonstrated construct validity. Factor analyses identified 3-4 subscales/measure. Participants reported being satisfied with the shortened measures, which took 5-10 minutes to complete. DISCUSSION: The new T1DAL measures for parents and partners of people with T1D are reliable, valid, and ready for use in research and clinical settings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Glucose variability and mood in adults with diabetes: A systematic review.

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.

Executive function mediates the link between externalizing behavior and HbA1c in children and adolescents with type 1 diabetes: A cross-national investigation.

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.