Changes in Bone Marrow Adipose Tissue in Transgender and Gender Non-Conforming Youth Undergoing Pubertal Suppression: A Pilot Study.

Pubertal suppression with gonadotropin-releasing hormone (GnRH) agonists in transgender and gender non-conforming (TGNC) youth may affect acquisition of peak bone mass. Bone marrow adipose tissue (BMAT) has an inverse relationship with bone mineral density (BMD). To evaluate the effect of pubertal suppression on BMAT, in this pilot study we prospectively studied TGNC youth undergoing pubertal suppression and cisgender control participants with similar pubertal status over a 12-month period. BMD was measured by dual-energy X-ray absorptiometry and peripheral quantitative computed tomography. Magnetic Resonance T1 relaxometry (T1-R) and spectroscopy (MRS) were performed to quantify BMAT at the distal femur. We compared the change in BMD, T1-R values, and MRS lipid indices between the two groups. Six TGNC (two assigned female and four assigned male at birth) and three female control participants (mean age 10.9 and 11.7 years, respectively) were enrolled. The mean lumbar spine BMD Z-score declined by 0.29 in the TGNC group, but increased by 0.48 in controls (between-group difference 0.77, 95% CI: 0.05, 1.45). Similar findings were observed with the change in trabecular volumetric BMD at the 3% tibia site (-4.1% in TGNC, +3.2% in controls, between-group difference 7.3%, 95% CI: 0.5%-14%). Distal femur T1 values declined (indicative of increased BMAT) by 7.9% in the TGNC group, but increased by 2.1% in controls (between-group difference 10%, 95% CI: -12.7%, 32.6%). Marrow lipid fraction by MRS increased by 8.4% in the TGNC group, but declined by 0.1% in controls (between-group difference 8.5%, 95% CI: -50.2%, 33.0%). In conclusion, we observed lower bone mass acquisition and greater increases in BMAT indices by MRI and MRS in TGNC youth after 12 months of GnRH agonists compared with control participants. Early changes in BMAT may underlie an alteration in bone mass acquisition with pubertal suppression, including alterations in mesenchymal stem cells within marrow.

Opportunities for Enhanced Transition of Care Preparation for Adolescents and Emerging Adults With Type 1 Diabetes: Use of the READDY Transition Tool.

There is an ongoing need to determine best practices for effective transition from pediatric to adult care for adolescents and emerging adults (EAs) with type 1 diabetes given the potential for poor health outcomes post-transfer. This study evaluated self-reported confidence ratings as measured by the Readiness of Emerging Adults with Diabetes Diagnosed in Youth (READDY) tool among adolescents and EAs with type 1 diabetes and the association of the confidence ratings with clinical and demographic characteristics, as well as provider documentation of relevant anticipatory guidance topics. The READDY is a diabetes-specific tool used to collect patient-reported confidence in transition preparation topics to target educational interventions. These interventions are divided into four domains: Diabetes Knowledge, Health System Navigation, Insulin Self-Management, and Health Behaviors. A retrospective chart review was conducted of patients 15-24 years of age with type 1 diabetes who completed the READDY survey between January 2017 and January 2018 at a single center. Overall patient-reported confidence levels were high. However, adolescents and EAs endorsed their lowest levels of confidence on items assessing knowledge of alcohol, tobacco, sexual health, and the impact of diabetes on pregnancy (females only), with the percentages of low scores of 20.7, 25.9, 35.9, and 42.9%, respectively. Documentation of provider counseling about screening and prevention of diabetes comorbidities, alcohol use, and tobacco use was associated with scores in the higher range for the corresponding item in the READDY survey. These findings highlight an opportunity to create interventions related to developmentally important topics for adolescents and EAs with type 1 diabetes to enhance successful transition preparation.

Learning experience design of an mHealth self-management intervention for adolescents with type 1 diabetes.

Type 1 diabetes (T1D) is a lifelong and chronic condition that can cause severely compromised health. The T1D treatment regimen is complex, and is a particular challenge for adolescents, who frequently experience a number of treatment adherence barriers (e.g., forgetfulness, planning and organizational challenges, stress). Diabetes Journey is a gamified mHealth program designed to improve T1D self-management through a specific focus on decreasing adherence barriers and improving executive functioning skills for adolescents. Grounded in situativity theory and guided by a sociotechnical-pedagogical usability framework, Diabetes Journey was designed, developed, and evaluated using a learning experience design approach. This approach applied design thinking methods within a Successive Approximation Model design process. Iterative design and formative evaluation were conducted across three design phases, and improvements were implemented following each phase. Findings from the user testing phase indicate Diabetes Journey is a user-friendly mHealth program with high usability that holds promise for enhancing adolescents' T1D self-management. Implications for future designers and researchers are discussed regarding the social dimension of the sociotechnical-pedagogical usability framework. An extension to the framework is proposed to extend the social dimension to include socio-cultural and contextual considerations when designing mHealth applications. Consideration of the pedagogical and sociocultural dimensions of learning is imperative when developing psychoeducational interventions.

Quality Improvement in Diabetes Care: A Review of Initiatives and Outcomes in the T1D Exchange Quality Improvement Collaborative.

Despite immense strides in therapeutic advances, clinical outcomes continue to be less than ideal for people with type 1 diabetes. This discrepancy has prompted an outpouring of quality improvement (QI) initiatives to address the medical, psychosocial, and health equity challenges that complicate ideal type 1 diabetes care and outcomes. This article reviews a framework for QI in diabetes care that guided the development of the T1D Exchange Quality Improvement Collaborative to improve care delivery and health outcomes in type 1 diabetes. Evaluation of the methodology, outcomes, and knowledge gained from these initiatives will highlight the importance of continued QI initiatives in diabetes care.

Therapeutic Inertia in Pediatric Diabetes: Challenges to and Strategies for Overcoming Acceptance of the Status Quo.

Despite significant advances in therapies for pediatric type 1 diabetes, achievement of glycemic targets remains elusive, and management remains burdensome for patients and their families. This article identifies common challenges in diabetes management at the patient-provider and health care system levels and proposes practical approaches to overcoming therapeutic inertia to enhance health outcomes for youth with type 1 diabetes.

Hormonal contraceptive choices in a clinic-based series of transgender adolescents and young adults.

Aims: To describe the use of hormonal contraceptives for menstrual management and/or pregnancy prevention in a clinic-based series of transgender adolescents and young adults who were assigned female at birth (transmasculine identity). Methods: We performed a chart review of post-menarchal transgender assigned-female-at-birth (AFAB) patients, age 10-25 years, seen at CCHMC Transgender Health Clinic for at least 2 visits between July 1, 2013 and September 17, 2016, and who were not on a puberty suppression method. We collected data including choice of hormonal contraceptive and indication (menstrual suppression, pregnancy prevention, or both), duration of use, initiation of sexual activity, reported sexual partners, and use of gender-affirming hormone therapy (i.e., testosterone). We present simple descriptive statistics. Results: A total of 231 patients met inclusion criteria, with ages from 11 to 25 years. Of those, 135 (59%) were using a hormonal contraceptive method. Most patients (67%) used hormonal contraception for the indication of menstrual suppression. Most commonly used method was depot medroxyprogesterone (DMPA) (49 patients), followed by combined oral contraceptives (COC) and norethindrone (progestin-only pill, POP) (34 patients each). Thirteen patients used 52 mg levonorgestrel IUD (LNG-IUD). Of the total sample (n = 231), 82 (36%) reported sexual activity, 35 of whom (43% of sexually active patients) reported sexual intercourse with assigned-male-at-birth (AMAB) partners and/or penile-vaginal intercourse. Among 35 patients at risk for pregnancy, only 21 (60%) were using hormonal contraception. Over half (54%) of sexually active patients taking testosterone discontinued their hormonal contraceptive method once they stopped having menses. Discussion: Within a sample of transgender AFAB adolescents, half of whom were taking testosterone, a variety of contraceptives were used, including depot medroxyprogesterone, combined oral contraceptives, and levonorgestrel IUD. Among those taking testosterone, many patients discontinued contraception once they stopped having menses.

Diabetes management mediating effects between diabetes symptoms and health-related quality of life in adolescents and young adults with type 1 diabetes.

OBJECTIVES: The primary objective was to investigate the mediating effects of diabetes management in the relationship between diabetes symptoms and generic health-related quality of life (HRQOL) in adolescents and young adults (AYAs) with type 1 diabetes. The secondary objective explored patient health communication and perceived treatment adherence barriers as mediators in a serial multiple mediator model. METHODS: The PedsQL 3.2 Diabetes Module 15-item diabetes symptoms summary score, 18-item diabetes management summary score, and PedsQL 4.0 generic core scales were completed in a 10-site national field test study by 418 AYA aged 13 to 25 years with type 1 diabetes. Diabetes symptoms and diabetes management were tested for bivariate and multivariate linear associations with overall generic HRQOL. Mediational analyses were conducted to test the hypothesized mediating effects of diabetes management as an intervening variable between diabetes symptoms and generic HRQOL. RESULTS: The predictive effects of diabetes symptoms on HRQOL were mediated in part by diabetes management. In predictive analytics models utilizing multiple regression analyses, demographic and clinical covariates, diabetes symptoms, and diabetes management significantly accounted for 53% of the variance in generic HRQOL (P < 0.001), demonstrating a large effect size. Patient health communication and perceived treatment adherence barriers were significant mediators in an exploratory serial multiple mediator model. CONCLUSIONS: Diabetes management explains in part the effects of diabetes symptoms on HRQOL in AYA with type 1 diabetes. Patient health communication to healthcare providers and perceived treatment adherence barriers further explain the mechanism in the relationship between diabetes symptoms and overall HRQOL.

Diabetes symptoms predictors of health-related quality of life in adolescents and young adults with type 1 or type 2 diabetes.

OBJECTIVES: The objective was to investigate the patient-reported diabetes symptoms predictors of generic health-related quality of life (HRQOL) in adolescents and young adults (AYA) with type 1 or type 2 diabetes. METHODS: The 15-item PedsQL™ 3.2 Diabetes Module Diabetes Symptoms Summary Score and PedsQL™ 4.0 Generic Core Scales were completed in a 10-site national field test study by 513 AYA ages 13-25 years with type 1 (n = 424) or type 2 (n = 89) diabetes. Diabetes symptoms were tested for bivariate and multivariate linear associations with generic HRQOL. RESULTS: Diabetes symptoms were associated with decreased HRQOL in bivariate analyses. In predictive analytics models utilizing hierarchical multiple regression analyses controlling for relevant demographic and clinical covariates, diabetes symptoms accounted for 38 and 39% of the variance in patient-reported generic HRQOL for type 1 and type 2 diabetes, respectively, reflecting large effect sizes. The diabetes symptoms facets hyperglycemia symptoms, hypoglycemia symptoms, and nonspecific diabetes symptoms individually accounted for a significant percentage of the variance in separate exploratory predictive analytics models after controlling for demographic and clinical covariates, with small-to-large effect sizes. CONCLUSIONS: Diabetes symptoms are potentially modifiable predictors of generic HRQOL in AYA with diabetes. Identifying specific diabetes symptoms or symptoms facets that are the most important predictors from the patient perspective facilitates a patient-centered approach in clinical research, clinical trials, and practice designed to enhance overall generic HRQOL in AYA with diabetes.

Psychosocial Patient-Reported Outcomes in Pediatric and Adolescent Diabetes: a Review and Case Example.

PURPOSE OF REVIEW: The purpose of this review is to define psychosocial patient-reported outcomes (PROs) relevant to pediatric and adolescent diabetes populations. Potential domains for PROs include a spectrum of emotional, behavioral, social, physical, overall health, and/or care management areas. A literature review of potential PRO measures, selection criteria, and implementation strategies including a case example will be presented. RECENT FINDINGS: Among the pediatric, adolescent, and emerging adult populations, research indicates a relative higher risk for distress, depression, anxiety, and eating disorders as compared to peers without diabetes. Use of PRO measures can expand providers' focus beyond glycemic control, or simply hemoglobin A1c, to better appreciate the impact of diabetes on the whole child/adolescent, and provide services that address patients' individually identified needs, which are most salient to them. Successful selection and implementation of psychosocial PRO measures should be designed to include pathways for real-time provider interaction with the patient and respective PRO data to guide clinical care.

Health-system-based interventions to improve care in pediatric and adolescent type 1 diabetes.

Despite significant advances in pharmacology and technology, glycemic targets are difficult to achieve for patients with type 1 diabetes (T1D) and management remains burdensome for patients and their families. Quality improvement (QI) science offers a methodology to identify an aim, evaluate complex contributors to the goal, and test potential interventions to achieve outcomes of interest. Day-to-day management of diabetes is often an iterative process but interventions exist at all care levels: individual patient and family, clinic, and larger population and health system. This article reviews current literature and proposes novel QI interventions for enhancing health outcomes, with attention to essential determinants or drivers of improved glycemic control and patient experience for pediatric T1D in the context of the Chronic Care Model. In-depth consideration of key drivers of successful T1D care, including self-management and integration of technology, are explored, and examples of larger health systems with improved outcomes, including Learning Health Systems are highlighted.

Incorporating the Six Core Elements of Health Care Transition in Type 1 Diabetes Care for Emerging Adults.

A growing body of literature finds persistent problems in the provision of recommended health care transition services, as well as adverse outcomes associated with the lack of these services in emerging adults with type 1 diabetes. The Six Core Elements of Health Care Transition offers a structured approach to the phases of health care transition support for both pediatric and adult diabetes practices. This article reviews strategies to incorporate the Six Core Elements into ambulatory diabetes care to support successful health care transition for emerging adults with type 1 diabetes.

Assessing the Revised Safer Dx Instrument® in the understanding of ambulatory system design changes for type 1 diabetes and autism spectrum disorder in pediatrics.

OBJECTIVES: We sought within an ambulatory safety study to understand if the Revised Safer Dx instrument may be helpful in identification of diagnostic missed opportunities in care of children with type 1 diabetes (T1D) and autism spectrum disorder (ASD). METHODS: We reviewed two months of emergency department (ED) encounters for all patients at our tertiary care site with T1D and a sample of such encounters for patients with ASD over a 15-month period, and their pre-visit communication methods to better understand opportunities to improve diagnosis. We applied the Revised Safer Dx instrument to each diagnostic journey. We chose potentially preventable ED visits for hyperglycemia, diabetic ketoacidosis, and behavioral crises, and reviewed electronic health record data over the prior three months related to the illness that resulted in the ED visit. RESULTS: We identified 63 T1D and 27 ASD ED visits. Using the Revised Safer Dx instrument, we did not identify any potentially missed opportunities to improve diagnosis in T1D. We found two potential missed opportunities (Safer Dx overall score of 5) in ASD, related to potential for ambulatory medical management to be improved. Over this period, 40 % of T1D and 52 % of ASD patients used communication prior to the ED visit. CONCLUSIONS: Using the Revised Safer Dx instrument, we uncommonly identified missed opportunities to improve diagnosis in patients who presented to the ED with potentially preventable complications of their chronic diseases. Future researchers should consider prospectively collected data as well as development or adaptation of tools like the Safer Dx.

Online Educational Resources for Youth Living With Type 1 Diabetes Transitioning to Adult Care: An Environmental Scan of Canadian Content.

OBJECTIVES: There are many educational resources for adolescents and young adults living with type 1 diabetes; however, it is unknown whether they address the breadth of topics related to transition to adult care. Our aim in this study was to collect educational resources relevant to Canadian youth and assess their quality and comprehensiveness in addressing the knowledge necessary for youth to prepare for interdependent management of their diabetes. METHODS: We conducted an environmental scan, a systematic assessment and analysis, of online education resources in English and French relevant to Canadian youth living with type 1 diabetes. Resources were screened using an open education resource evaluation grid and relevant resources were mapped to the Readiness for Emerging Adults with Diabetes Diagnosed in Youth, a validated diabetes transition readiness assessment tool. RESULTS: From 44 different sources, 1,245 resources were identified and, of these, 760 were retained for analysis. The majority were webpages (50.1%) and downloadable PDFs (42.4%), and 12.1% were interactive. Most resources covered Diabetes Knowledge (46.0%), Health Behaviour (23.8%), Insulin and Insulin Pump Management (11.8% and 8.6%, respectively), and Health-care System Navigation (9.7%). Topic areas with the fewest resources were disability accommodations (n=5), sexual health/function (n=4), and locating trustworthy diabetes resources (n=3). CONCLUSIONS: There are many resources available for those living with type 1 diabetes preparing to transition to adult care, with the majority pertaining to diabetes knowledge and the least for navigation of the health system. Few resources were available on the topics of substance use, sexual health, and reproductive health. An interactive presentation of these resources, as well as a central repository to house these resources, would improve access for youth and diabetes care providers during transition preparation.

Young Adults with Type 1 Diabetes.

Young adults experience multiple developmental transitions across social, educational, vocational, residential, and financial life domains. These transitions are potential competing priorities to managing a chronic condition such as type 1 diabetes and can contribute to poor psychosocial and medical outcomes. In this narrative review, we describe population outcomes of young adult populations and the unique considerations associated with managing type 1 diabetes in young adulthood. We provide an overview of the current evidence-based strategies to improve care for young adults with type 1 diabetes and recommendations for future directions in the field.

Safer Type 1 Diabetes Care at Home: SEIPS-based Process Mapping with Parents and Clinicians.

Introduction: The limited data indicate that pediatric medical errors in the outpatient setting, including at home, are common. This study is the first step of our Ambulatory Pediatric Patient Safety Learning Lab to address medication errors and treatment delays among children with T1D in the outpatient setting. We aimed to identify failures and potential solutions associated with medication errors and treatment delays among outpatient children with T1D. Methods: A transdisciplinary team of parents, safety researchers, and clinicians used Systems Engineering Initiative for Patient Safety (SEIPS) based process mapping of data we collected through in-home medication review, observation of administration, chart reviews, parent surveys, and failure modes and effects analysis (FMEA). Results: Eight (57%) of the 14 children who had home visits experienced 18 errors (31 per 100 medications). Four errors in two children resulted in harm, and 13 had the potential for harm. Two injuries occurred when parents failed to treat severe hypoglycemia and lethargy, and two were due to repeated failures to administer insulin at home properly. In SEIPS-based process maps, high-risk errors occurred during communication between the clinic and home or in management at home. Two FMEAs identified interventions to better communicate with families and support home care, especially during evolving illness. Conclusion: Using SEIPS-based process maps informed by multimodal methods to identify medication errors and treatment delays, we found errors were common. Better support for managing acute illness at home and improved communication between the clinic and home are potentially high-yield interventions.

Patient Demographics and Clinical Outcomes Among Type 1 Diabetes Patients Using Continuous Glucose Monitors: Data From T1D Exchange Real-World Observational Study.

BACKGROUND: The benefits of Continuous Glucose Monitoring (CGM) on glycemic management have been demonstrated in numerous studies; however, widespread uptake remians limited. The aim of this study was to provide real-world evidence of patient attributes and clinical outcomes associated with CGM use across clinics in the U.S. based T1D Exchange Quality Improvement (T1DX-QI) Collaborative. METHOD: We examined electronic Health Record data from eight endocrinology clinics participating in the T1DX-QI Collaborative during the years 2017-2019. RESULTS: Among 11,469 type 1 diabetes patients, 48% were CGM users. CGM use varied by race/ethnicity with Non-Hispanic Whites having higher rates of CGM use (50%) compared to Non-Hispanic Blacks (18%) or Hispanics (38%). Patients with private insurance were more likely to use CGM (57.2%) than those with public insurance (33.3%) including Medicaid or Medicare. CGM users had lower median HbA1c (7.7%) compared to nonusers (8.4%). Rates of diabetic ketoacidosis (DKA) and severe hypoglycemia were significantly higher in nonusers compared to CGM users. CONCLUSION: In this real-world study of patients in the T1DX-QI Collaborative, CGM users had better glycemic control and lower rates of DKA and severe hypoglycemia (SH) events, compared to nonusers; however, there were significant sociodemographic disparities in CGM use. Quality improvement and advocacy measures to promote widespread and equitable CGM uptake have the potential to improve clinical outcomes.

Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study.

OBJECTIVES: Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia. STUDY DESIGN: This one-year study included an initial 26-week randomized controlled trial of CGM with FBI (CGM+FBI) and CGM alone (Standard-CGM) compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI (BGM-Crossover) and both original CGM groups continued this technology. RESULTS: Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (<70 mg/dL) with CGM use (CGM+FBI: baseline 3.4%, 52 weeks 2.0%; Standard-CGM: baseline 4.1%, 52 weeks 2.1%; BGM-Crossover: 26 weeks 4.5%, 52 weeks 1.7%, P-values <.001). Hemoglobin A1c was unchanged with CGM use (CGM+FBI: baseline 8.3%, 52 weeks 8.2%; Standard-CGM: baseline 8.2%, 52 weeks 8.0%; BGM-Crossover: 26 weeks 8.1%, 52 weeks 8.3%). Sensor use remained high (52-week study visit: CGM+FBI 91%, Standard-CGM 92%, BGM-Crossover 88%). CONCLUSION: Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, persistently wore CGM. However, pervasive hyperglycemia remained unmitigated. This indicates an urgent need for further advances in diabetes technology, behavioral support, and diabetes management educational approaches to optimize glycemia in young children.

Trends in Type 1 Diabetic Ketoacidosis During COVID-19 Surges at 7 US Centers: Highest Burden on non-Hispanic Black Patients.

CONTEXT: The impact of the COVID-19 pandemic on individuals with type 1 diabetes remains poorly defined. OBJECTIVE: We examined United States trends in diabetic ketoacidosis (DKA) among individuals with type 1 diabetes (T1D) during the COVID-19 pandemic at 7 large US medical centers and factors associated with these trends. METHODS: We compared DKA events among children and adults with T1D during COVID-19 surge 1 (March-May 2020) and COVID-19 surge 2 (August-October 2020) to the same periods in 2019. Analysis was performed using descriptive statistics and chi-square tests. RESULTS: We found no difference in the absolute number of T1D patients experiencing DKA in 2019 vs 2020. However, a higher proportion of non-Hispanic Black (NHB) individuals experienced DKA in 2019 than non-Hispanic White (NHW) individuals (44.6% vs 16.0%; P < .001), and this disparity persisted during the COVID-19 pandemic (48.6% vs 18.6%; P < .001). DKA was less common among patients on continuous glucose monitor (CGM) or insulin pump in 2020 compared to 2019 (CGM: 13.2% vs 15.0%, P < .001; insulin pump: 8.0% vs 10.6%, P < .001). In contrast to annual DKA totals, a higher proportion of patients had DKA during COVID-19 surges 1 and 2 compared to the same months in 2019 (surge 1: 7.1% vs 5.4%, P < .001; surge 2: 6.6% vs 5.7%, P = .001). CONCLUSION: DKA frequency increased among T1D patients during COVID-19 surges with highest frequency among NHB patients. DKA was less common among patients using CGM or insulin pumps. These findings highlight the urgent need for improved strategies to prevent DKA among patients with T1D-not only under pandemic conditions, but under all conditions-especially among populations most affected by health inequities.