Design of a randomized controlled trial of digital health and community health worker support for diabetes management among low-income patients.

BACKGROUND: Insulin-dependent diabetes is a challenging disease to manage and involves complex behaviors, such as self-monitoring of blood glucose. This can be especially challenging in the face of socioeconomic barriers and in the wake of the COVID-19 pandemic. Digital health self-monitoring interventions and community health worker support are promising and complementary best practices for improving diabetes-related health behaviors and outcomes. Yet, these strategies have not been tested in combination. This protocol paper describes the rationale and design of a trial that measures the combined effect of digital health and community health worker support on glucose self-monitoring and glycosylated hemoglobin. METHODS: The study population was uninsured or publicly insured; lived in high-poverty, urban neighborhoods; and had poorly controlled diabetes mellitus with insulin dependence. The study consisted of three arms: usual diabetes care; digital health self-monitoring; or combined digital health and community health worker support. The primary outcome was adherence to blood glucose self-monitoring. The exploratory outcome was change in glycosylated hemoglobin. CONCLUSION: The design of this trial was grounded in social justice and community engagement. The study protocols were designed in collaboration with frontline community health workers, the study aim was explicit about furthering knowledge useful for advancing health equity, and the population was focused on low-income people. This trial will advance knowledge of whether combining digital health and community health worker interventions can improve glucose self-monitoring and diabetes-related outcomes in a high-risk population.

Increasing Insulin Pump Use Among 12- to 26-Year-Olds With Type 1 Diabetes: Results From the T1D Exchange Quality Improvement Collaborative.

Insulin pump therapy in pediatric type 1 diabetes has been associated with better glycemic control than multiple daily injections. However, insulin pump use remains limited. This article describes an initiative from the T1D Exchange Quality Improvement Collaborative aimed at increasing insulin pump use in patients aged 12-26 years with type 1 diabetes from a baseline of 45% in May 2018 to >50% by February 2020. Interventions developed by participating centers included increasing in-person and telehealth education about insulin pump technology, creating and distributing tools to assist in informed decision-making, facilitating insulin pump insurance approval and onboarding processes, and improving clinic staff knowledge about insulin pumps. These efforts yielded a 13% improvement in pump use among the five participating centers, from 45 to 58% over 22 months.

Multi-Clinic Quality Improvement Initiative Increases Continuous Glucose Monitoring Use Among Adolescents and Young Adults With Type 1 Diabetes.

Continuous glucose monitoring (CGM) use is associated with improved A1C outcomes and quality of life in adolescents and young adults with diabetes; however, CGM uptake is low. This article reports on a quality improvement (QI) initiative of the T1D Exchange Quality Improvement Collaborative to increase CGM use among patients in this age-group. Ten centers participated in developing a key driver diagram and center-specific interventions that resulted in an increase in CGM use from 34 to 55% in adolescents and young adults over 19-22 months. Sites that performed QI tests of change and documented their interventions had the highest increases in CGM uptake, demonstrating that QI methodology and sharing of learnings can increase CGM uptake.

COVID-19 Hospitalization in Adults with Type 1 Diabetes: Results from the T1D Exchange Multicenter Surveillance Study.

CONTEXT: Diabetes mellitus is associated with increased COVID-19 morbidity and mortality, but there are few data focusing on outcomes in people with type 1 diabetes. OBJECTIVE: The objective of this study was to analyze characteristics of adults with type 1 diabetes for associations with COVID-19 hospitalization. DESIGN: An observational multisite cross-sectional study was performed. Diabetes care providers answered a 33-item questionnaire regarding demographics, symptoms, and diabetes- and COVID-19-related care and outcomes. Descriptive statistics were used to describe the study population, and multivariate logistic regression models were used to analyze the relationship between glycated hemoglobin (HbA1c), age, and comorbidities and hospitalization. SETTING: Cases were submitted from 52 US sites between March and August 2020. PATIENTS OR OTHER PARTICIPANTS: Adults over the age of 19 with type 1 diabetes and confirmed COVID-19 infection were included. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Hospitalization for COVID-19 infection. RESULTS: A total of 113 cases were analyzed. Fifty-eight patients were hospitalized, and 5 patients died. Patients who were hospitalized were more likely to be older, to identify as non-Hispanic Black, to use public insurance, or to have hypertension, and less likely to use continuous glucose monitoring or insulin pumps. Median HbA1c was 8.6% (70 mmol/mol) and was positively associated with hospitalization (odds ratio 1.42, 95% confidence interval 1.18-1.76), which persisted after adjustment for age, sex, race, and obesity. CONCLUSIONS: Baseline glycemic control and access to care are important modifiable risk factors which need to be addressed to optimize care of people with type 1 diabetes during the worldwide COVID-19 pandemic.

Kidney transplantation and donation in the transgender population: A single-institution case series.

The medical needs of the transgender population are increasingly recognized within the US health care system. Hormone therapy and gender-affirming surgery present distinct anatomic, hormonal, infectious, and psychosocial issues among transgender kidney transplant donors and recipients. We present the first reported experience with kidney transplantation and donation in transgender patients. A single-center case series (January 2014-December 2018) comprising 4 transgender kidney transplant recipients and 2 transgender living donors was constructed and analyzed. Experts in transplant surgery, transplant psychiatry, transplant infectious disease, pharmacy, and endocrinology were consulted to discuss aspects of care for these patients. Four transgender patients identified as male-to-female and 2 as female-to-male. Three of 6 had gender-affirming surgeries prior to transplant surgery, 1 of whom had further procedures posttransplant. Additionally, 4 patients were on hormone therapy. All 6 had psychiatric comorbidities. The 4 grafts have done well, with an average serum creatinine of 1.45 mg/dL at 2 years (range 1.01-1.85 mg/dL). However, patients encountered various postoperative complications, 1 of which was attributable to modified anatomy. Thus, transgender kidney transplant patients can present novel challenges in regard to surgical considerations as well as pre- and posttransplant care. Dedicated expertise is needed to optimize outcomes for this population.

Is One-Pen, One-Patient Achievable in the Hospital? A Quality Improvement Project to Reduce Risks of Inadvertent Insulin Pen Sharing at a Large Academic Medical Center.

BACKGROUND: The Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Institute for Safe Medicine Practices (ISMP) have issued warnings regarding the risk of potential transmission of blood-borne diseases if an insulin pen is used for more than one person. Many hospitals continue to use insulin pens due to their benefits of decreased risk of dosing error and improved work efficiency. Best practices for insulin pen use have been published; however, little is known about how these perform in hospitals. METHODS: This article describes a multifaceted quality improvement project to address the safety issues of single-patient insulin pens. Major interventions included adding patient-specific bar coding on insulin pens, redesign of labels, systematic removal of discharged patients' medications, and ongoing staff education. RESULTS: Self-reported events of insulin pen sharing events over 40 months showed a significant increase in the number of patient-days between events. The significant change occurred after implementation of patient-specific bar code scanning. There was a gradual decrease in latent errors found during medication drawer audits, and nursing compliance with patient-specific bar code scanning improved over time, reaching 90% on the last recorded month. Of 35 expert recommendations for insulin pen safety, 28 directly affected pen sharing-8 had been implemented prior to this project, and 20 had been implemented by the conclusion. CONCLUSION: Insulin pen use is highly complex in hospital settings where multiple steps provide opportunities for error. To protect patients, all gaps need to be reviewed, and interventions that address major contributing factors are required to ensure safe insulin pen use.

Early hypoglycaemia and adherence after basal insulin initiation in a nationally representative sample of Medicare beneficiaries with type 2 diabetes.

AIMS: To estimate risk factors associated with early hypoglycaemia and its impact on adherence to and persistence with therapy in Medicare Part D beneficiaries with type 2 diabetes who are initiating basal insulin (BI). MATERIALS AND METHODS: This retrospective analysis used a 5% sample of Medicare files from 2007-2013, identifying beneficiaries with type 2 diabetes initiating BI from 1 January 2008 to 31 December 2012. Early hypoglycaemia was defined as ≥1 hypoglycaemic event ≤6 months postindex. Outcomes included medication adherence and persistence over 12- and 36-month follow-up. Multivariable logistic and Cox regression analyses were conducted to examine factors associated with early hypoglycaemia and BI adherence/persistence. RESULTS: Of the 14 466 included patients, 1315 (9.1%) experienced hypoglycaemia ≤6 months after initiating BI. Factors associated with early hypoglycaemia were female sex (odds ratio [OR] 1.16 [95% confidence interval [CI] 1.02-1.32]), receipt of a low-income subsidy under Medicare Part D (OR 1.20 [95% CI 1.01-1.43]), high diabetes complication score index (OR 1.08 [95% CI 1.01-1.15]), and hypoglycaemia during the baseline period (OR 4.24 [95% CI 3.63-4.96]). At 12 months, patients with baseline hypoglycaemia were less likely to be adherent to (OR 0.81 [95% CI 0.70-0.93]) and more likely to discontinue (OR 1.33 [95% CI 1.07-1.66]) their insulin therapy. Results were similar at 36 months. CONCLUSIONS: Within 6 months of BI initiation, almost 1 in 10 Medicare Part D beneficiaries experienced hypoglycaemia. Early hypoglycaemia was associated with decreased adherence to BI treatment over 12- and 36-month follow-up.

Predictors of Short Intensive Care Unit Stay for Patients with Diabetic Ketoacidosis Using a Novel Emergency Department-Based Resuscitation and Critical Care Unit.

BACKGROUND: The resuscitation and critical care unit is a novel emergency department-intensive care unit designed to provide early critical care to emergency department patients for ≤24 h. OBJECTIVES: This study sought to identify clinical variables associated with short intensive care unit (ICU) stays in patients with diabetic ketoacidosis (DKA), who commonly require ICU-level care. METHODS: We conducted a retrospective, single-center, cross-sectional study of DKA patients ≥18 years of age who presented to an academic, urban hospital emergency department over 16 months. Patient demographics and clinical variables extracted from medical records were compared between prolonged ICU stay patients of ≥24 h versus short ICU stay patients (SSPs) of <24 h. ICU care was defined as treatment in the resuscitation and critical care unit or inpatient ICU. RESULTS: One hundred sixty-eight emergency department visits with a primary diagnosis of DKA were analyzed. There were 53 prolonged ICU stay patients, 58 SSPs, and 57 patients required no ICU time. SSPs had significantly higher initial serum bicarbonate (13.0 vs. 9.0 mEq/L, p = 0.01) and shorter anion gap closure time (9.8 vs. 14.4 hours, p = 0.003). Medication nonadherence was a significantly more frequent precipitant in SSPs (67.2% vs. 47.2%, p = 0.03). Initial anion gap, glucose, beta-hydroxybutyrate, and severity of illness scores were not significantly different between groups. After multivariate logistic regression adjusting for variables significant from univariate analysis, higher initial bicarbonate (p = 0.04) and medication nonadherence (p = 0.03) remained significantly associated with SSPs. CONCLUSIONS: Patients with DKA with short ICU stays have higher initial bicarbonate levels and are more likely to have medication nonadherence than patients requiring prolonged critical care. These variables may identify patients with DKA who are best treated in an emergency department-intensive care unit to potentially reduce inpatient ICU use.

Awareness of Prediabetes and Engagement in Diabetes Risk-Reducing Behaviors.

INTRODUCTION: Studies have demonstrated the benefit of weight loss and physical activity for diabetes prevention among those with prediabetes. Despite this evidence, only about half of people with prediabetes report engaging in these behaviors. One presumed barrier is low patient awareness of prediabetes. The purpose of this study is to examine the impact of prediabetes awareness on the odds of engagement in diabetes risk-reduction behaviors. METHODS: A pooled cross-sectional analysis of adults from two cycles (2007-2008, 2009-2010) of the National Health and Nutrition Examination Survey was conducted. Those with prediabetes were identified by excluding people with self-reported diabetes and then screening for hemoglobin A1c values between 5.7% and 6.4%. This group was then divided based on self-reported prediabetes. Multivariate logistic regression was used to estimate the effect of prediabetes awareness on the odds of engagement in physical activity, weight management, and the combination of physical activity and weight management. RESULTS: Of those meeting the defined criteria for prediabetes (n=2,694), only 11.8% (n=288) were aware of their status. Prediabetes-aware individuals had higher odds of engagement in the combination of moderate physical activity plus BMI-appropriate weight management (AOR=1.5, 95% CI=1.1, 2.0), and the combination of at least 150 minutes/week of moderate activity and 7% weight loss in the past year (AOR=2.4, 95% CI=1.1, 5.6). CONCLUSIONS: Prediabetes-aware adults have increased odds of engagement in physical activity and weight management. Increasing patients' awareness of prediabetes could result in increased performance of exercise and weight management behaviors and, most importantly, decreased risk of future diabetes.

Provider and patient directed financial incentives to improve care and outcomes for patients with diabetes.

Incentive programs directed at both providers and patients have become increasingly widespread. Pay-for-performance (P4P) where providers receive financial incentives to carry out specific care or improve clinical outcomes has been widely implemented. The existing literature indicates they probably spur initial gains which then level off or partially revert if incentives are withdrawn. The literature also indicates that process measures are easier to influence through P4P programs but that intermediate outcomes such as glucose, blood pressure, and cholesterol control are harder to influence, and the long-term impact of P4P programs on health is largely unknown. Programs directed at patients show greater promise as a means to influence patient behavior and intermediate outcomes such as weight loss; however, the evidence for long-term effects are lacking. In combination, both patient and provider incentives are potentially powerful tools but whether they are cost-effective has yet to be determined.

Haplotype-based analysis of alpha 2A, 2B, and 2C adrenergic receptor genes captures information on common functional loci at each gene.

The alpha 2-adrenergic receptors (alpha2-AR) mediate physiological effects of epinephrine and norepinephrine. Three genes encode alpha2-AR subtypes carrying common functional polymorphisms (ADRA2A Asn251Lys, ADRA2B Ins/Del301-303 and ADRA2C Ins/Del322-325). We genotyped these functional markers plus a panel of single nucleotide polymorphisms evenly spaced over the gene regions to identify gene haplotype block structure. A total of 24 markers were genotyped in 96 Caucasians and 96 African Americans. ADRA2A and ADRA2B each had a single haplotype block at least 11 and 16 kb in size, respectively, in both populations. ADRA2C had one haplotype block of 10 kb in Caucasians only. For the three genes, haplotype diversity and the number of common haplotypes were highest in African Americans, but a similar number of markers (3-6) per block was sufficient to capture maximum diversity in either population. For each of the three genes, the haplotype was capable of capturing the information content of the known functional locus even when that locus was not genotyped. The alpha2-AR haplotype maps and marker panels are useful tools for genetic linkage studies to detect effects of known and unknown alpha2-AR functional loci.

Haplotype structure of the beta adrenergic receptor genes in US Caucasians and African Americans.

The beta-adrenergic receptors (beta-AR) are G protein-coupled receptors activated by epinephrine and norepinephrine and are involved in a variety of their physiological functions. Previously, three beta-AR genes (ADRB1, ADRB2 and ADRB3) were resequenced, identifying polymorphisms that were used in genetic association studies of cardiovascular and metabolic disorders. These studies have produced intriguing but inconsistent results, potentially because the known functional variants: ADRB1 Arg389Gly and Gly49Ser, ADRB2 Arg16Gly and Gln27Glu, and ADRB3 Arg64Trp provided an incomplete picture of the total functional diversity at these genes. Therefore, we created marker panels for each beta-AR gene that included the known functional markers and also other markers evenly spaced and with sufficient density to identify haplotype block structure and to maximize haplotype diversity. A total of 27 markers were genotyped in 96 US Caucasians and 96 African Americans. In both populations and for each gene, a single block with little evidence of historical recombination was observed. For each gene, haplotype captured most of the information content of each functional locus, even if that locus was not genotyped, and presumably haplotype would capture the signal from unknown functional loci whose alleles are of moderate abundance. This study demonstrates the utility of using beta-AR gene haplotype maps and marker panels as tools for linkage studies on beta-AR function.