Hybrid Closed Loop Systems Improve Glycemic Control and Quality of Life in Historically Minoritized Youth with Diabetes.

Background: We assessed changes in glycemic control and person-reported outcome measures (PROMs) with t:slim X2 insulin pump with Control-IQ technology use among historically minoritized youth who are least likely to access hybrid closed loop (HCL) technology. Methods: This single-arm, prospective pilot study enrolled 15 publicly insured, insulin pump-naïve, non-Hispanic Black youth ages 6 to <21 years with type 1 diabetes and hemoglobin A1c (HbA1c) ≥10% in a 6-month study of HCL use. The primary outcome was absolute change in time in range (TIR) (70-180 mg/dL). Secondary outcomes included other continuous glucose monitor metrics, PROMs, and diabetic ketoacidosis (DKA) incidence. Results: For 13 youth (median 14.8 years, 53.3% female, HbA1c 11.7%) who completed the study, baseline TIR of 12.3% (6.3-27.1%) increased 23.7%-points (16.9, 30.5%; P < 0.001) or 5.7 h per day. Percent time >250 mg/dL decreased 33.9%-points (-44.8, -23.1%; P < 0.001) or 8.1 h per day from a baseline of 69.4% (51.6, 84.0%). Median time in HCL was 78.3% (59.7, 87.3%). Youth received 10.1 (9.2, 11.9) boluses per day, 71.7% (63.8, 79.3%) of which were HCL-initiated autoboluses. Diabetes-specific quality of life increased among parents (P < 0.001) and youth (P = 0.004), and diabetes distress decreased in both groups (P < 0.001, P = 0.005). Improvements in glycemia did not correlate with any baseline youth or parent PROMs. DKA was high at baseline (67 episodes/100-person years) and did not increase during the intervention (72 episodes/100-person years, P = 0.78). Conclusion: Improvements in glycemic control and quality of life exceeding pivotal trial findings without increased safety risks among historically minoritized youth emphasize the need for equitable access to HCL systems. ClinicalTrials.gov: clinicaltrials.gov ID (NCT04807374).

Acute and Chronic Adverse Outcomes of Type 1 Diabetes.

Type 1 diabetes is associated with both acute and chronic complications. Acute complications include diabetic ketoacidosis and severe hypoglycemia. Chronic complications can be microvascular or macrovascular. Microvascular complications include retinopathy, nephropathy, and neuropathy. The pathophysiology of microvascular complications is complex. Hyperglycemia is a common underlying risk factor, underscoring the importance of optimizing glycemic management. Patients with type 1 diabetes are also at increased risk of macrovascular complications including coronary artery disease and vascular disease. The American Diabetes Association provides screening guidelines for chronic complications of diabetes. Adherence to these guidelines is an important aspect of diabetes care.

Case Report: Insulin hypersensitivity in youth with type 1 diabetes.

Objective: Immediate type I, type III, and delayed type IV hypersensitivity reactions to insulin are rare, but potentially serious complications of exogenous insulin administration required for the treatment of type 1 diabetes (T1D). Methods: We present four cases of insulin hypersensitivity reactions occurring in youth with T1D and a literature review of this topic. Results: Insulin hypersensitivity reactions included types I, III, and IV with presentations ranging from localized urticaria, erythematous nodules, and eczematous plaques to anaphylaxis with respiratory distress. Reactions occurred in youth with newly diagnosed T1D and in those with long-standing T1D who were using both injection and insulin pump therapy. Multidisciplinary care involving pediatric endocrinology and allergy/immunology utilizing trials of many adjunct therapies yielded minimal improvement. Despite the use of various treatments, including antihistamines, topical therapies, immunosuppressant medications, desensitization trials, and intravenous immune globulin, cutaneous reactions, elevated hemoglobin A1c levels, and negative effects on quality of life remain persistent challenges. One patient became one of the youngest pancreas transplant recipients in the world at age 12 years due to uncontrollable symptoms and intolerable adverse effects of attempted therapies. Conclusion: Although rare, insulin hypersensitivity reactions negatively affect glycemic control and quality of life. These cases demonstrate the varying severity and presentation of insulin hypersensitivity reactions along with the limited success of various treatment approaches. Given the life-sustaining nature of insulin therapy, further studies are needed to better understand the underlying pathophysiology of insulin hypersensitivity and to develop targeted treatment approaches.

Virtual Learning and Youth-Onset Type 2 Diabetes During the COVID-19 Pandemic.

INTRODUCTION: Cases and severity of presentation of youth-onset type 2 diabetes (Y-T2D) increased during the COVID-19 pandemic, yet the potential drivers of this rise remain unknown. During this time public health mandates paused in-person education and limited social interactions, resulting in radical lifestyle changes. We hypothesized that the incidence and severity of presentation of Y-T2D increased during virtual learning amidst the COVID-19 pandemic. MATERIALS AND METHODS: We conducted a single center retrospective chart review to identify all newly diagnosed cases of Y-T2D (n=387) at a pediatric tertiary care center in Washington, DC during three pre-determined learning periods as defined by learning modality in Washington, DC Public Schools: pre-pandemic in-person learning (3/11/2018-3/13/2020), pandemic virtual learning (3/14/2020-8/29/2021), and pandemic in-person learning (8/30/2021-3/10/2022) periods. RESULTS: Incident cases were stable during pre-pandemic in-person learning (3.9 cases/month, 95% CI: 2.8 - 5.4 cases/month), increased to a peak during virtual learning (18.7 cases/month, 95% CI: 15.9 - 22.1 cases/month), and declined with return to in-person learning (4.3 cases/month, 95% CI: 2.8 - 6.8 cases/month). Y-T2D incidence was 16.9 (95% CI: 9.8-29.1, p<0.001) and 5.1-fold higher (95% CI: 2.9-9.1, p<0.001) among non-Hispanic Black and Latinx youth, respectively, throughout the study period. Overall COVID-19 infection rates at diagnosis were low (2.5%) and were not associated with diabetes incidence (p=0.26). DISCUSSION/CONCLUSIONS: This study provides timely insights into an important and modifiable correlate of Y-T2D incidence, its disproportionate impact on underserved communities, and the need to consider the effects on long-term health outcomes and pre-existing healthcare inequities when designing public policy.

Differences in positive expectancy of hybrid closed loop (HCL) insulin delivery systems do not explain racial differences in HCL use.

Aims: Hybrid closed loop (HCL) insulin delivery systems improve glycemia and quality of life among youth with type 1 diabetes (T1D), however there are inequities in use. We aimed to evaluate whether differences in positive expectancy of HCL systems may explain differences in use. Methods: Fifteen publicly-insured, non-Hispanic Black (NHB) youth with hemoglobin A1C (HbA1c) ≥ 10% enrolled in a study exploring changes in glycemia and person reported outcomes (PRO) during 6 months of Tandem t:slim X2 insulin pump with Control-IQ technology. At baseline youth and parents completed PROs, including Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) survey assessing positive expectancy of HCL use, and Problem Areas in Diabetes (PAID) survey assessing diabetes-related distress. Differences between this cohort and the Tandem Control-IQ pediatric pivotal trial (DCLP5) cohort were assessed. Results: As compared to the DCLP5 cohort (0% NHB, 10% publicly-insured), baseline glycemic indicators were suboptimal (MHbA1c 11.9 ± 1.4% vs 7.6 ± 0.9%, p < 0.0001; continuous glucose monitor (CGM) time-above-range > 180 mg/dL 82 ± 15% vs 45 ± 18%, p < 0.0001). INSPIRE scores in both cohorts were equally high among youth (80 ± 10 vs 77 ± 13, p = 0.41) and parents (88 ± 14 vs 85 ± 11, p = 0.37). PAID scores were higher among parents (68 ± 19 vs 43 ± 16, p < 0.0001), but not youth (43 ± 16 vs 35 ± 16, p = 0.09) in the historically marginalized cohort as compared to the DCLP5 cohort. Conclusions: Despite differences in glycemic control and diabetes related burden, positive expectancy of HCL systems is comparable among historically marginalized youth with T1D and the predominantly non-Hispanic White, privately insured DCLP5 cohort. These findings suggest that differences in perceptions of HCL technology may not explain inequities in use.

Applying the use of shared medical appointments (SMAs) to improve continuous glucose monitor (CGM) use, glycemic control, and quality of life in marginalized youth with type 1 diabetes: Study protocol for a pilot prospective cohort study.

Background: Continuous glucose monitors (CGMs) have been associated with improved glycemic control and diabetes-related quality of life in youth with type 1 diabetes (T1D), however use is lowest among youth from low-income households and racial/ethnic minorities. Shared medical appointments (SMAs) have been shown to improve glycemic control and reduce diabetes distress in adolescents with T1D, but a focus on marginalized youth has been lacking. This prospective cohort pilot study will assess feasibility and acceptability of the SMA intervention and impact on CGM uptake and sustained use, glycemic control, and diabetes distress in marginalized youth with elevated hemoglobin A1c (HbA1C). Methods: The pilot study will recruit 20 publicly insured youth with T1D aged 8-12 years who identify as non-Hispanic Black or Latinx and have had at least one HbA1C value > 8% in the past year and their primary caretaker. The trial will employ an enrollment visit, SMA visits every 3 months over a 12-month study period, and a 6-month follow-up observational period. Feasibility measures include proportion of eligible youth successfully recruited for participation, proportion initiating CGM, SMA attendance, and retention through study completion. Acceptability will be assessed using satisfaction surveys. Changes in glycemic control will be assessed using CGM metrics and A1c from baseline to completion of the 12-month SMA intervention, as well as 3 and 6-months after completion of the SMA intervention. Conclusion: Implementing SMAs for marginalized youth has the potential to address diabetes disparities by optimizing clinical and psychosocial outcomes for the most vulnerable youth living with T1D.Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05431686.

Post-Transplantation Diabetes Mellitus in Pediatric Patients.

More than 80% of pediatric solid organ transplant (SOT) recipients now survive into young adulthood and many encounter transplant-related complications. Post-transplantation diabetes mellitus (PTDM), sometimes also referred to as post-transplant diabetes or new onset diabetes after transplant, occurs in 3-20% of pediatric SOT recipients depending upon the organ transplanted, age at transplantation, immunosuppressive regimen, family history, and time elapsed since transplant. To diagnose PTDM, hyperglycemia must persist beyond the initial hospitalization for transplantation when a patient is on stable doses of immunosuppressive medications. Though standard diagnostic criteria used by the American Diabetes Association (ADA) to diagnose diabetes are employed, clinicians need to be aware of the limitations of using these criteria in this unique patient population. Management of PTDM parallels strategies used for type 2 diabetes (T2D), while also carefully considering comorbidities and potential interactions with immunosuppressive medications in these patients. In caring for patients with PTDM, it is important to be familiar with these interactions and comorbidities in order to coordinate care with the transplant team and optimize outcomes for these patients.