A novel approach to understanding and assessing the emotional side of type 1 diabetes: The Type 1-Diabetes Distress Assessment System.

AIMS: To describe the development of a novel, conceptually sound instrument with contemporary content for assessing diabetes distress (DD) among adults with type 1 diabetes. METHODS: Qualitative interviews with 15 adults and 7 clinicians were used to develop Core (intensity of DD emotional burden) and primary Source (key DD contributors) items. These were administered to a national sample recruited from the TCOYD Research Registry, T1D Exchange and our previous studies. Exploratory and confirmatory factor analyses were undertaken, along with reliability and construct validity studies, and cut-point analyses to determine elevated DD. RESULTS: Analyses based on 650 respondents yielded an 8-item Core DD scale (α = 0.95) and 10 2- or 3-item DD Source Scales (α range = 0.53-0.88): Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack of Diabetes Resources, Technology Challenges, Burden to Others and Worries about Complications. Core and Source scores were significantly associated with criterion variables: Higher DD scores were significantly linked with higher HbA1C, more frequent episodes of severe hypoglycaemia, missed boluses, and poorer quality of life (p > 0.001). A ≥2.0 scale cut-point to define elevated DD is suggested. CONCLUSIONS: The new T1-Diabetes Distress Assessment System demonstrated good reliability and validity, and with measures of both Core emotional burden and Sources of DD, it provides a contemporary, flexible and practical approach to assessing DD that can be used seamlessly to inform intervention for clinicians and researchers.

Training peers to deliver mental health support to adults with type 1 diabetes using the REACHOUT mobile app.

AIMS: While peer support research is growing in the Type 1 diabetes (T1D) community, the peer supporter training (PST) process is rarely documented in detail. This study provides a comprehensive description of PST and evaluation for the REACHOUT mental health support intervention, and examines the feasibility and perceived utility of PST. METHODS: Fifty-three adults with T1D were recruited to participate in a 6-hour, zoom-based PST program for mental health support. The program was structured in three parts: (1) internal motivation, resilience and empathy; (2) mindfulness, emotions and diabetes distress; and (3) active listening and deferring clinical questions to professionals. Candidates were evaluated based on eight pre-established competency criteria during a 5-day support trial with an assigned standardized T1D participant. Perceived usefulness of training skills was also assessed 3 months into the REACHOUT mental health support intervention. RESULTS: Fifty-one of the fifty-three candidates who completed training achieved the criteria to graduate. Mean scores for the eight competency domains were: listens actively (4.55); asks open-ended questions (4.12); expresses empathy (4.42); avoids passing judgment (4.67); sits with strong emotions (4.44); refrains from giving advice (4.38); makes reflections (4.5); and defers medical questions (4.58). Of the skills learned during the PST, 95% rated interpreting and discussing diabetes distress profile and expressing empathy as moderately to extremely useful. CONCLUSIONS: Findings demonstrate that it is feasible to recruit and graduate the number of trainees needed using a rigorous process. Only by making training protocols available can the PST be replicated and translated to other T1D populations (e.g. adolescents, parents of children with T1D).

Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

The Hypoglycemic Fear Syndrome: Understanding and Addressing This Common Clinical Problem in Adults With Diabetes.

Although a broad literature on fear of hypoglycemia and its impact on people with type 1 or type 2 diabetes has accumulated over the past three decades, there has been surprisingly little guidance concerning how best to tackle this problem in clinical care. The aim of this article is to begin filling this gap by describing the "hypoglycemic fear syndrome," which we define as hypoglycemic fear that has become so overwhelming that it leads to avoidance behaviors and chronically elevated glucose levels. We begin by presenting several illustrative cases, describing the syndrome and how it is most commonly presented in clinical care, and detailing its most common precipitants. We then offer practical, evidence-based strategies for clinical intervention, based on the literature and our clinical experience.

The ubiquity of diabetes distress among adults with type 1 diabetes in an urban, academic practice: A template for intervention.

AIMS: The aim of this study was to assess the patterns of diabetes distress within an urban, technology-oriented academic clinical practice to inform staff training and intervention. METHODS: Adults with type 1 diabetes completed the Type 1 Diabetes Distress Scale at their regular clinic visit. Descriptive statistics were generated to document the prevalence of diabetes distress overall, and from seven primary sources of distress: powerlessness, disease management, hypoglycaemia, negative social perceptions, eating, physician and family/friends. Additional analyses explored relations between diabetes distress, demographic characteristics and disease status. RESULTS: The prevalence of elevated diabetes distress was 30% overall, with 88% of the sample reporting elevated distress from at least one primary source. Women reported more elevated distress overall, and from the primary sources. There was an inverse relationship between diabetes duration with total diabetes distress (r = -0.19) and with the powerlessness subscale (r = -0.28). Also, those without micro- and/or macrovascular complications more frequently reported elevated distress from powerlessness (85%) compared to those having complications (61%). Use of technology (continuous glucose monitoring, insulin pumps) was not significantly related to diabetes distress. Diabetes distress was positively correlated with HbA1c. About 22% of individuals with HbA1c <53 mmol/mol (<7%) had elevated total distress. About a third of the sample (34%-39%) reported elevated distress from powerlessness, hypoglycaemia, negative social perceptions, eating, or family/friends. CONCLUSIONS: It is critical to understand clinic-specific patterns of diabetes distress in order to customise staff training and intervention programmes, and thereby reduce distress among unique populations of adults with type 1 diabetes in different settings.

Personal Continuous Glucose Monitoring Use Among Adults with Type 2 Diabetes: Clinical Efficacy and Economic Impacts.

PURPOSE OF REVIEW: This article reviews recent clinical efficacy research and economic analysis of the use of personal continuous glucose monitoring (CGM) in type 2 diabetes (T2D). RECENT FINDINGS: Studies from the past 5 years include a variety of randomized controlled trials, meta-analyses, and other studies which generally favor CGM over self-monitoring of blood glucose (SMBG) in T2D, especially among people with T2D treated with insulin. Concurrently, some studies show no significant difference, but there is no evidence of worse outcomes with CGM. CGM is frequently associated with greater reduction in HbA1c than is SMBG. HbA1c reductions tend to be greater when baseline HbA1c is higher. Reductions in hypoglycemia and hyperglycemia have also been demonstrated with CGM in people with T2D, as have comfort with, preference for, and psychosocial benefits of CGM compared to SMBG. There is a small but growing evidence base on the economics and cost-effectiveness of CGM in T2D. CGM has been clearly demonstrated to have clinical benefits in people with T2D, especially among those treated with insulin. Economic and cost-effectiveness data are more scant but are generally favorable. CGM should be an important consideration in the management of T2D, and its use is likely to increase as efficacy data accumulate further and as costs associated with CGM gradually decrease.

Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection.

BACKGROUND: To enable delivery of high quality patient-centered care, as well as to allow primary care health systems to allocate appropriate resources that align with patients' identified self-management problems (SM-Problems) and priorities (SM-Priorities), a practical, systematic method for assessing self-management needs and priorities is needed. In the current report, we present patient reported data generated from Connection to Health (CTH), to identify the frequency of patients' reported SM-Problems and SM-Priorities; and examine the degree of alignment between patient SM-Priorities and the ultimate Patient-Healthcare team member selected Behavioral Goal. METHODS: CTH, an electronic self-management support system, was embedded into the flow of existing primary care visits in 25 primary care clinics and was used to assess patient-reported SM-Problems across 12 areas, patient identified SM-Priorities, and guide the selection of a Patient-Healthcare team member selected Behavioral Goal. SM-Problems included: BMI, diet (fruits and vegetables, salt, fat, sugar sweetened beverages), physical activity, missed medications, tobacco and alcohol use, health-related distress, general life stress, and depression symptoms. Descriptive analyses documented SM-Problems and SM-Priorities, and alignment between SM-Priorities and Goal Selection, followed by mixed models adjusting for clinic. RESULTS: 446 participants with ≥ one chronic diseases (mean age 55.4 ± 12.6; 58.5% female) participated. On average, participants reported experiencing challenges in 7 out of the 12 SM-Problems areas; with the most frequent problems including: BMI, aspects of diet, and physical activity. Patient SM-Priorities were variable across the self-management areas. Patient- Healthcare team member Goal selection aligned well with patient SM-Priorities when patients prioritized weight loss or physical activity, but not in other self-management areas. CONCLUSION: Participants reported experiencing multiple SM-Problems. While patients show great variability in their SM-Priorities, the resulting action plan goals that patients create with their healthcare team member show a lack of diversity, with a disproportionate focus on weight loss and physical activity with missed opportunities for using goal setting to create targeted patient-centered plans focused in other SM-Priority areas. Aggregated results can assist with the identification of high frequency patient SM-Problems and SM-Priority areas, and in turn inform resource allocation to meet patient needs. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01945918 .

Quantification of DNA in Neonatal Dried Blood Spots by Adenine Tandem Mass Spectrometry.

Newborn screening programs have expanded to include molecular-based assays as first-tier tests and the success of these assays depends on the quality and yield of DNA extracted from neonatal dried blood spots (DBS). To meet high throughput and rapid turnaround time requirements, newborn screening laboratories adopted rapid DNA extraction methods that produce crude extracts. Quantification of DNA in neonatal DBS is not routinely performed due to technical challenges; however, this may enhance the performance of assays that are sensitive to amounts of input DNA. In this study, we developed a novel high throughput method to quantify total DNA in DBS. It is based on specific acid-catalyzed depurination of DNA followed by mass spectrometric quantification of adenine. The amount of adenine was used to calculate DNA quantity per 3.2 mm DBS. Reference intervals were established using archived, neonatal DBS (n = 501) and a median of 130.6 ng of DNA per DBS was obtained, which is in agreement with literature values. The intra- and interday variations were <15%. The limits of detection and quantification were 12.5 and 37.8 nmol/L adenine, respectively. We demonstrated that DNA from neonatal DBS can be successfully quantified in high throughput settings using instruments currently deployed in NBS laboratories.

A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

BACKGROUND: Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention. METHODS: A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS. DISCUSSION: This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation. TRIAL REGISTRATION: Registered with ClinicalTrials.gov - ClinicalTrials.gov ID: NCT01945918 , date 08/27/2013. Modifications have been updated.

Understanding the Areas and Correlates of Diabetes-Related Distress in Parents of Teens With Type 1 Diabetes.

OBJECTIVE: To identify the unique areas of diabetes-related distress (DD) for parents of teens with type 1 diabetes and parent and teen characteristics associated with DD. METHODS: Areas of DD were developed from structured interviews and translated into 46 survey items. Items were analyzed with exploratory factor analysis (EFA). RESULTS: An EFA with 332 parents (88% mothers) reduced items to four Parent Diabetes Distress Scale (PDDS) factors (20 items, α = .94): Personal, Teen Management, Parent/Teen Relationship, and Healthcare Team Distress. Parent DD was higher among fathers, younger or single parents, parents of teens with higher hemoglobin A1c or severe low blood glucose levels, authoritarian parenting, depressive symptoms, and low emotional support. CONCLUSIONS: 4 areas of parent DD were identified using a newly developed measure, the PDDS. DD was associated with family demographic, teen diabetes status, and parent contextual factors, and can help identify parents who may be more vulnerable to DD.

Practice context affects efforts to improve diabetes care for primary care patients: a pragmatic cluster randomized trial.

BACKGROUND: Efforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes. OBJECTIVE: To examine practice contextual features that moderate intervention effectiveness. DESIGN: Secondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care. PARTICIPANTS: Forty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment. MAIN MEASURES: The primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos). KEY RESULTS: Across the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p < .001), -.75(p = .004)); Medicaid: < 20 % vs. ≥ 20 % (-.20(p = .48), +.75 (p = .08), +.60(p = .02)); practice size: < 4 clinicians vs. ≥ 4 clinicians (+.56(p = .02), +1.96(p < .001), +.02(p = .91)); practice Change Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p < .001), +.67(p = .005)) and variability in practice Change Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm. CONCLUSIONS: This study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

When does personalized feedback make a difference? A narrative review of recent findings and their implications for promoting better diabetes self-care.

Providing behavioral, biomarker, or disease risk feedback to patients is a key component of most behavioral interventions in diabetes, but it remains unclear what is necessary for such feedback to be truly engaging and effective. We sought to identify how personalized health-related feedback is most effectively designed and delivered, and how feedback may be tailored to meet the needs of individual patients with diabetes. To do so, we systematically reviewed recent findings concerning the effectiveness of feedback in eight health-related areas, including several specific to diabetes care (blood glucose monitoring and HbA1c) and others which touch on broader care dimensions (blood pressure, cholesterol, dietary intake, pedometer usage, self-weighing, and medical imaging). Five interdependent characteristics of health-related feedback were identified (clarity of the feedback message, personal meaningfulness of the feedback, frequency of feedback, guidance and support accompanying feedback, and interplay between feedback and patient characteristics) and applications for use in diabetes care were provided. Findings suggested that feedback will be most effective when it is easy for patients to understand and is personally meaningful, frequency of feedback is appropriate to the characteristics of the behavior/biomarker, guidance for using feedback is provided, and feedback is qualified by patient characteristics. We suggest that the effectiveness of feedback to promote better diabetes outcomes requires careful consideration of the feedback message, how it is delivered, and characteristics of the recipients.

A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial.

BACKGROUND: Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers' needs for information about the patient's status or how the caregiver can help. OBJECTIVE: We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach. METHODS: We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a "CarePartner" outside their household. Patients randomized to "standard mHealth" (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients' responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to "mHealth+CP" (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient's status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments. RESULTS: Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05). Among patients with more depressive symptoms at enrollment, those randomized to mHealth+CP were more likely than standard mHealth patients to report excellent or very good general health during weekly IVR calls. CONCLUSIONS: Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients' medication adherence and caregiver communication. mHealth+CP may also decrease patients' risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms. Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical, infrequent retrospective surveys. TRIAL REGISTRATION: ClinicalTrials.gov NCT00555360; https://clinicaltrials.gov/ct2/show/NCT00555360 (Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B).

Practice facilitation to improve diabetes care in primary care: a report from the EPIC randomized clinical trial.

PURPOSE: We investigated 3 approaches for implementing the Chronic Care Model to improve diabetes care: (1) practice facilitation over 6 months using a reflective adaptive process (RAP) approach; (2) practice facilitation for up to 18 months using a continuous quality improvement (CQI) approach; and (3) providing self-directed (SD) practices with model information and resources, without facilitation. METHODS: We conducted a cluster-randomized trial, called Enhancing Practice, Improving Care (EPIC), that compared these approaches among 40 small to midsized primary care practices. At baseline and 9 months and 18 months after enrollment, we assessed practice diabetes quality measures from chart audits and Practice Culture Assessment scores from clinician and staff surveys. RESULTS: Although measures of the quality of diabetes care improved in all 3 groups (all P <.05), improvement was greater in CQI practices compared with both SD practices (P <.0001) and RAP practices (P <.0001); additionally, improvement was greater in SD practices compared with RAP practices (P <.05). In RAP practices, Change Culture scores showed a trend toward improvement at 9 months (P = .07) but decreased below baseline at 18 months (P <.05), while Work Culture scores decreased from 9 to 18 months (P <.05). Both scores were stable over time in SD and CQI practices. CONCLUSIONS: Traditional CQI interventions are effective at improving measures of the quality of diabetes care, but may not improve practice change and work culture. Short-term practice facilitation based on RAP principles produced less improvement in quality measures than CQI or SD interventions and also did not produce sustained improvements in practice culture.

EMBARK: A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA1c in Adults With Type 1 Diabetes.

OBJECTIVE: To compare the effectiveness of three interventions to reduce diabetes distress (DD) and improve HbA1c among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Individuals with T1D (n = 276) with elevated DD (a score >2 on the total Type 1 Diabetes Distress Scale) and HbA1c (>7.5%) were recruited from multiple settings and randomly assigned to one of three virtual group-based programs: 1) Streamline, an educator-led education and diabetes self-management program; 2) TunedIn, a psychologist-led program focused exclusively on emotional-focused DD reduction; or 3) FixIt, an integration of Streamline and TunedIn. Assessments of the primary outcomes of DD and HbA1c occurred at baseline and at 3, 6, and 12 months. RESULTS: All three programs demonstrated substantive and sustained reductions in DD (Cohen's d = 0.58-1.14) and HbA1c (range, -0.4 to -0.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared with Streamline participants (P = 0.007). Streamline and TunedIn participants achieved significantly greater HbA1c reductions than did FixIt participants (P = 0.006). CONCLUSIONS: DD can be successfully reduced among individuals with T1D with elevated HbA1c using both the educational/behavioral and emotion-focused approaches included in the study. Although both approaches are associated with significant and clinically meaningful reductions in DD and HbA1c, TunedIn, the emotion-focused program, had the most consistent benefits across both DD and HbA1c. The study findings suggest the overall value of group-based, fully virtual, and time-limited emotion-focused strategies, like those used in TunedIn, for adults with T1D.

Impact of anesthesia and surgery for congenital heart disease on the vitamin d status of infants and children: a prospective longitudinal study.

BACKGROUND: Vitamin D is recognized as a pleiotropic hormone important for the functioning of organ systems, including those central to critical illness pathophysiology. Recent studies have reported associations between vitamin D status and outcome among critically ill adults and children. Preoperative vitamin D status, impact of operative techniques, and relationship between immediate postoperative vitamin D levels and clinical course have not been described in the pediatric congenital heart disease (CHD) population. The objective of this study was to describe the impact of CHD surgery on vitamin D status and relationship between postoperative levels and clinical course. METHODS: A prospective cohort study was conducted from 2009 to 2011 at a single tertiary care pediatric hospital. A total of 58 children with CHD were enrolled and blood collected preoperatively, intraoperatively, and postoperatively. Serum 25-hydroxyvitamin D (25OHD) was measured using liquid chromatography-mass spectrometry. RESULTS: The mean preoperative 25OHD was 58.0 nM (SD, 22.4), with 42% being deficient (<50 nM). Postoperatively, we identified a 40% decline in 25OHD to 34.2 nM (SD, 14.5) with 86% being deficient. Intraoperative measurements determined that initiation of cardiopulmonary bypass coincided with abrupt decline. CHD patients requiring catecholamines had lower postoperative 25OHD (38.2 vs. 26.5 nM, P=0.007), findings confirmed through multivariate logistic regression. Lower postoperative 25OHD was associated with increased fluid requirements and intubation duration. CONCLUSIONS: Most CHD patients are vitamin-D deficient postoperatively due to low preoperative levels and a significant intraoperative decline. Interventional studies will be required to determine whether prevention of postoperative vitamin D deficiency improves outcome.

How Frequently and for How Long Do Adults With Type 2 Diabetes Use Management Apps? The REALL Study.

OBJECTIVE: The objective of the study is to identify predictors of utilization of a type 2 diabetes (T2D) management App over time for insulin users (IUs) and noninsulin users (NIUs). RESEARCH DESIGN AND METHODS: We followed over 16 weeks a national sample of unselected T2D adults who independently elected to download and pair a CONTOUR DIABETES App with their CONTOUR NEXT ONE glucose meter. App use and frequency of glucose testing were recorded. Baseline surveys recorded participant demographic, disease status, distress, medication taking, and views of technology to predict utilization. RESULTS: Mean age was 51.6 years (108 IUs; 353 NIUs), 48% were female, time with diabetes was 6.9 years, and self-reported HbA1c was 8.1% (36.3 mmol/mol). Mean duration of App use was 85.4 days and 40% stopped using the App before 16 weeks. Continuous users were older and reported higher distress, better medication taking, and more positive attitudes toward technology (all P < .01). IUs tested more frequently than NIUs, but frequency and intensity of testing decreased markedly for both groups over time. More predictors of App use frequency and testing occurred for NIUs than IUs: older age, higher HbA1c, lower distress, more medication taking (all P < .05). CONCLUSIONS: App use and testing decreased markedly over time. Variations in the predictors of frequency of App use suggest that the utilization of mobile technologies requires a tailored approach that addresses the specific needs of individual users, compared with adopting a one-size-fits-all strategy, and that IUs and NIUs may require very different strategies of customization.

Development and validation of fear of hypoglycemia screener: results from the T1D exchange registry.

BACKGROUND: Fear of Hypoglycemia (FoH) in people with diabetes has a significant impact on their quality of life, psychological well-being, and self-management of disease. There are a few questionnaires assessing FoH in people living with diabetes, but they are more often used in research than clinical practice. This study aimed to develop and validate a short and actionable FoH screener for adults living with type 1 diabetes (T1D) for use in routine clinical practice. METHODS: We developed an initial screener based on literature review and, interviews with healthcare providers (HCPs) and people with T1D. We developed a cross-sectional web-based survey, which was then conducted to examine the reliability and validity of the screener. Adults (aged ≥ 18 years) with diagnosis of T1D for ≥ 1 year were recruited from the T1D Exchange Registry (August-September 2020). The validation analyses were conducted using exploratory factor analyses, correlation, and multivariable regression models for predicting cut-off scores for the final screener. RESULTS: The final FoH screener comprised nine items assessing two domains, "worry" (6-items) and "avoidance behavior" (three items), in 592 participants. The FoH screener showed good internal consistency (Cronbach's α = 0.88). The screener also demonstrated high correlations (r = 0.71-0.75) with the Hypoglycemia Fear Survey and moderate correlations with depression, anxiety, and diabetes distress scales (r = 0.44-0.66). Multivariable regression analysis showed that higher FoH screener scores were significantly associated with higher glycated hemoglobin (HbA1c) (b = 0.04) and number of comorbidities (b = 0.03). CONCLUSIONS: This short FoH screener demonstrated good reliability and validity. Further research is planned to assess clinical usability to identify patients with FoH and assist effective HCP-patient conversations.

Aspects of culturally competent care are associated with less emotional burden among patients with diabetes.

BACKGROUND: Diabetes distress is associated with poor diabetes self-management and worse clinical outcomes. Whether there is an association between patient experience of health care and degree of emotional burden (EB) of diabetes distress is not known. OBJECTIVE: To investigate whether aspects of culturally competent care are associated with the EB of diabetes distress. DESIGN: Cross-sectional survey consisting of face-to-face interviews. SUBJECTS: A total of 502 ethnically diverse patients with diabetes receiving care in safety-net clinics in 2 cities. MEASURES: The main outcome measure was high EB on the Diabetes Distress Scale (mean score ≥ 3). The predictors were 3 domains (Doctor Communication--Positive Behaviors, Trust, and Doctor Communication-Health Promotion) of the Consumer Assessment of Healthcare Providers and Systems--Cultural Competence (Consumer Assessments of Healthcare Providers and Systems' Cultural Competence Item Set) instrument. RESULTS: Of 502 patients, 263 (52%) reported high EB. In adjusted logistic regressions controlling for sociodemographic and clinical factors, patient report of optimal Doctor Communication-Positive Behaviors (adjusted odds ratio, 0.46; 95% confidence interval, 0.39-0.54), and optimal Trust (adjusted odds ratio, 0.65; 95% confidence interval, 0.54-0.78) were associated with lower EB. Doctor Communication-Health Promotion Communication was not associated with EB. DISCUSSION: Patient report of better doctor communication behavior and higher trust in physician are inversely associated with high EB among patients with diabetes. Further research should determine whether interventions improving patient physician communication and trust can lower the EB of diabetes.