Improving Diabetes Control in a Medicaid Managed Care Population With Complex Needs.

INTRODUCTION: People enrolled in Medicaid managed care who struggle with diabetes control often have complex medical, behavioral, and social needs. Here the authors report the results of a program designed to partner with primary care teams to address those needs. METHODS: A nonprofit organization partnered with a Medicaid managed care plan and a Federally Qualified Health Center in California to enroll people with A1cs >9% in a 12-month program. The program team included a community health worker, certified diabetes care and education specialist/registered dietitian, behavioral health counselor, and registered nurse. They developed patient-led action plans, connected patients to community resources, and supported behavior changes to improve diabetes control. Baseline assessments of behavioral health conditions and social needs were collected. Monthly A1c values were tracked for participants and a comparison group. RESULTS: Of the 51 people enrolled, 83% had at least 1 behavioral health condition. More than 90% reported at least 1 unmet social need. The average monthly A1c among program participants was 0.699 lower than the comparison group post-enrollment (P = .0008), and the disparity in A1c between Hispanic and non-Hispanic White participants at enrollment declined. DISCUSSION: Participants had high levels of unmet medical, behavioral, and social needs. Addressing these needs resulted in a rapid and sustained improvement in A1c control compared to non-enrollees and a reduction in disparity of control among Hispanic participants. CONCLUSION: By partnering with a primary care team, a program external to Federally Qualified Health Center primary care can improve clinical outcomes for people with complex needs living with diabetes.

Narrative review of the role of technology in pediatric diabetes: from testing blood glucose to subcutaneous automated therapy and hope for cure.

Background and Objective: Type 1 diabetes, the most common cause of diabetes in pediatrics, is defined by the hyperglycemia that results from the permanent autoimmune damage to the pancreas. The Diabetes Control and Complications Trial (DCCT) demonstrated that strict glycemic control targeting lower HbA1c goals can both delay the onset and progression of its complications that include diabetic neuropathy, nephropathy, retinopathy, and increased cardiovascular events. Our primary objective is to review the literature available regarding the technology applied for the treatment of diabetes, not only aiding patients' quality of life but addressing its effects on hypoglycemia and reduced risk of the long-term complications. It will synthesize the evolution of glucose monitoring devices; the development of insulin: from animal to recombinant engineering, smart insulin in the future; the development of algorithm-driven insulin delivery devices, the closed loop system/artificial pancreas; and the future utilization of technology to support islet cell transplant with the goal of a long-term cure. Emphasis will be made on what is known about the impact on its outcomes in children and adolescents. Methods: A literature search was conducted using PubMed for publications from 1985 to present. Keywords used: type 1 diabetes, children, adolescents, pediatrics, continuous glucose monitoring (CGM), insulin pumps. Referenced articles include other reviews, current care guidelines as supported by cross sectional studies, cohort studies and randomized clinical trials. Key Content and Findings: Understanding the pathophysiology of type 1 diabetes has led to the design of technology that facilitates glucose monitoring and insulin administration in a personalized manner. The current technology has improved outcomes and quality of life by decreasing hypoglycemic events and decreasing risk of long-term metabolic complications. Barriers remain, for children and adults, often driven by patient's preference as well as their understanding of the limitations of what they are wearing. Conclusions: With the progressive evolution of this technology, it is now realistic to lower the burden of diabetes self-management while reducing hypoglycemia and risk of complications that otherwise impact daily life from academics, physical activity, career choices and even life expectancy.

Identifying heterogeneity using recursive partitioning: evidence from SMS nudges encouraging voluntary retirement savings in Mexico.

Individuals regularly struggle to save for retirement. Using a large-scale field experiment ( N = 97 , 149 ) in Mexico, we test the effectiveness of several behavioral interventions relative to existing policy and each other geared toward improving voluntary retirement savings contributions. We find that an intervention framing savings as a way to secure one's family future significantly improves contribution rates. We leverage recursive partitioning techniques and identify that the overall positive treatment effect masks subpopulations where the treatment is even more effective and other groups where the treatment has a significant negative effect, decreasing contribution rates. Accounting for this variation is significant for theoretical and policy development as well as firm profitability. Our work also provides a methodological framework for how to better design, scale, and deploy behavioral interventions to maximize their effectiveness.

Smoking and other patient factors in HPV-mediated oropharynx cancer: A retrospective cohort study.

PURPOSE: To characterize the significance of patient-level influences, including smoking history, on oncologic outcomes in human papillomavirus (HPV)-mediated oropharyngeal cancer (OPC). MATERIALS AND METHODS: A bi-institutional retrospective cohort study of previously untreated, HPV+ OPC patients who underwent curative treatment from 1/1/2008 to 7/1/2018 was performed. The primary outcome was disease-free survival (DFS) and the primary exposure was ≤10 versus >10-pack-year (PY)-smoking history. RESULTS: Among 953 OPC patients identified, 342 individuals with HPV+ OPC were included. The median patient age was 62 years, 33.0% had a > 10-PY-smoking history, 60.2% had AJCC8 stage I disease, and 35.0% underwent primary surgery. The median follow-up was 49 months (interquartile range [IQR] 32-75 months). Four-year DFS-estimates were similar among patients with ≤10-PY-smoking history (78.0%, 95% CI:71.7%-83.1%) compared to >10-PYs (74.8%; 95% CI:65.2%-82.0%; log-rank:p = 0.53). On univariate analysis, >10-PY-smoking history did not correlate with DFS (hazard ratio[HR]:1.15;95% CI:0.74-1.79) and remained nonsignificant when forced into the multivariable model. On adjusted analyses, stage, treatment paradigm, and age predicted DFS. Neither >10-PYs, nor any other definition of tobacco use (e.g., current smoker or > 20-PYs) was predictive of DFS, overall survival, or disease-specific survival. Conversely, age nonsignificantly and significantly predicted adjusted DFS (adjusted HR[aHR]:1.02,95% CI:0.997-1.05, p = 0.08), overall survival (aHR 1.05; 95% CI: 1.02-1.08; p = 0.002) and disease-specific survival (aHR 1.04;95% CI: 0.99-1.09;p = 0.09). CONCLUSION: Other than age, patient-level influences may not be primary drivers of HPV+ OPC outcomes. Although limited by its modest sample size, our study suggests the significance of smoking has been overstated in this disease. These findings and the emerging literature collectively do not support risk-stratification employing the >10-PY threshold. LEVEL OF EVIDENCE: Level 4.

Brain MRIs may be of low value in most children diagnosed with isolated growth hormone deficiency.

OBJECTIVES: Brain MRIs are considered essential in the evaluation of children diagnosed with growth hormone deficiency (GHD), but there is uncertainty about the appropriate cut-off for diagnosis of GHD and little data about the yield of significant abnormal findings in patients with peak growth hormone (GH) of 7-10 ng/mL. We aimed to assess the frequency of pathogenic MRIs and associated risk factors in relation to peak GH concentrations. METHODS: In this retrospective multicenter study, charts of patients diagnosed with GHD who subsequently had a brain MRI were reviewed. MRIs findings were categorized as normal, incidental, of uncertain significance, or pathogenic (pituitary hypoplasia, small stalk and/or ectopic posterior pituitary and tumors). Charges for brain MRIs and sedation were collected. RESULTS: In 499 patients, 68.1% had normal MRIs, 18.2% had incidental findings, 6.6% had uncertain findings, and 7.0% had pathogenic MRIs. Those with peak GH<3 ng/mL had the highest frequency of pathogenic MRIs (23%). Only three of 194 patients (1.5%) with peak GH 7-10 ng/mL had pathogenic MRIs, none of which altered management. Two patients (0.4%) with central hypothyroidism and peak GH<4 ng/mL had craniopharyngioma. CONCLUSIONS: Pathogenic MRIs were uncommon in patients diagnosed with GHD except in the group with peak GH<3 ng/mL. There was a high frequency of incidental findings which often resulted in referrals to neurosurgery and repeat MRIs. Given the high cost of brain MRIs, their routine use in patients diagnosed with isolated GHD, especially patients with peak GH of 7-10 ng/mL, should be reconsidered.

Erratum. Establishment of the T1D Exchange Quality Improvement Collaborative (T1DX-QI). Clinical Diabetes 2020;38:141-151 (DOI: 10.2337/cd19-0032).

[This corrects the article on p. 141 in vol. 38, PMID: 32327886.].

Prevalence of Retinal Diseases and Associated Risk Factors in an African Population From Mwanza, Tanzania.

BACKGROUND AND OBJECTIVE: To determine the prevalence of retinal disease among a population in Mwanza, Tanzania, and to identify relevant risk factors for retinal disorders in this cohort. PATIENTS AND METHODS: A cross-sectional population-based study was conducted in Mwanza, Tanzania, among patients older than 18 years. Participants completed a demographics survey and underwent an ophthalmic examination that included fundus photography. RESULTS: Complete data were available for 1,007 (93.8%) of the 1,073 persons examined. The prevalence of vitreoretinal disorders was 22.8% (230/1,007). The leading retinal diseases were age-related macular degeneration (7.0%), hypertensive retinopathy (4.5%), and macular scars (2.7%). CONCLUSION: This study is the first population-based study of retinal disease in Mwanza. The findings reveal a considerable burden of retinal disease in this region, suggesting a need for trained local ophthalmic personnel and resources. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:S17-S25.].

The value of serial newborn screening for congenital hypothyroidism using thyroxine (T4) in the neonatal intensive care unit.

OBJECTIVE: To evaluate the role of serial newborn screening of congenital hypothyroidism using thyroxine (T4) in the neonatal intensive care unit (NICU). SUBJECTS: Newborn screen results were reviewed from a single academic NICU during 2007-2016 (n = 6100). Thyroid function levels were reviewed in patients treated for hypothyroidism during that period. Duration of treatment was followed after discharge. RESULTS: Overall incidence of treated hypothyroidism was 1:103 with increasing incidence inversely related to birth weight. Among treated infants (n = 59), initial newborn screen demonstrated sensitivity and specificity of 74.1% and 84.9%, respectively; second screen demonstrated rates of 85.7% and 76.1%, respectively. Based on follow-up data, prevalence of permanent congenital hypothyroidism in our NICU population was 1:870 (n = 7); two patients would have been missed with a single screen. CONCLUSION: Abnormal T4 on newborn screening is common for preterm neonates. Higher rates of permanent congenital hypothyroidism highlight the need for screening beyond the newborn screen.

The Turner syndrome research registry: Creating equipoise between investigators and participants.

To address knowledge gaps about Turner syndrome (TS) associated disease mechanisms, the Turner Syndrome Society of the United States created the Turner Syndrome Research Registry (TSRR), a patient-powered registry for girls and women with TS. More than 600 participants, parents or guardians completed a 33-item foundational survey that included questions about demographics, medical conditions, psychological conditions, sexuality, hormonal therapy, patient and provider knowledge about TS, and patient satisfaction. The TSRR platform is engineered to allow individuals living with rare conditions and investigators to work side-by-side. The purpose of this article is to introduce the concept, architecture, and currently available content of the TSRR, in anticipation of inviting proposals to utilize registry resources.

Long-term intraocular pressure changes after femtosecond laser-assisted cataract surgery in healthy eyes and glaucomatous eyes.

PURPOSE: To examine the long-term effect of femtosecond laser-assisted cataract surgery on intraocular pressure (IOP) in healthy (control) and glaucomatous eyes. SETTING: University of Colorado, Aurora, Colorado, and Vanderbilt University, Nashville, Tennessee, USA. DESIGN: Retrospective case series. METHODS: The study comprised patients aged 18 to 89 years meeting the inclusion criteria. Combination procedures were excluded. The main outcome measure was the change in the mean IOP from baseline to postoperatively. RESULTS: Of the 504 eyes meeting the criteria, 278 were in the glaucoma/glaucoma suspect group and 226 in the control group. Both groups had an initial mean increase in IOP 1 day postoperatively (control: +2.0 mm Hg; 95% confidence interval [CI], 1.4-2.6; glaucoma/glaucoma suspect: +3.4 mm Hg; 95% CI, 2.5-4.2) (both P < .001). The increase was significantly higher in the glaucoma/glaucoma suspect group. The IOP returned to baseline levels at 1 week. At 1 month, both groups had a significant decrease in IOP that persisted until year 1 in the control group and through 3 years in the glaucoma group. The number of IOP medications was unchanged in the glaucoma group during follow-up. The glaucoma/glaucoma suspect group achieved significantly greater IOP lowering than the control group after 6 months. CONCLUSIONS: Control eyes and eyes with glaucoma had an initial mean IOP rise 1 day after femtosecond laser-assisted cataract surgery. This was followed by a significant decrease starting at 1 month. The reduction was sustained through 3 years in the glaucoma group.

Maternal Serum Eye Drops in the Management of Pediatric Persistent Corneal Epithelial Defects: A Case Series.

PURPOSE: We report our experience with the use of maternally derived serum eye drops as adjunctive treatment in the management of pediatric persistent corneal epithelial defects. METHODS: Five eyes of 4 patients were identified in a retrospective review of pediatric patients with persistent corneal epithelial defects who received maternal serum drops. Diagnoses associated with the defects comprised pontine tegmental cap dysplasia with bilateral cranial nerve V1, V2, V3, and VII palsies; pontine tegmental cap dysplasia with left cranial nerve V1, VII, and VIII palsies; traumatic left cranial nerve II, V1, V2, and VI palsies due to a basilar skull fracture; and Stevens-Johnson syndrome with ocular involvement. We evaluated the feasibility of using maternally derived serum drops; thus, we looked at the ability to prepare and tolerate the drops as well as any complications that could have been associated with treatment. Other data collected included visual acuity, corneal examination, and current and previous treatments. RESULTS: Both the duration of therapy and time of follow-up ranged from 5 to 28 months. All patients experienced improvement or resolution of their corneal epithelial defects within 3 weeks of initiating serum eye drops. Furthermore, there were no adverse effects from the use of allogeneic serum drops. CONCLUSIONS: Maternal serum eye drops are a well-tolerated and potentially beneficial addition to the management of pediatric persistent corneal epithelial defects.

Implementation of Depression Screening and Global Health Assessment in Pediatric Subspecialty Clinics.

PURPOSE: Adolescents with chronic illness face greater risk of psychosocial difficulties, complicating disease management. Despite increased calls to screen for patient-reported outcomes, clinical implementation has lagged. Using quality improvement methods, this study aimed to investigate the feasibility of standardized screening for depression and assessment of global health and to determine recommended behavioral health follow-up, across three pediatric subspecialty clinics. METHODS: A total of 109 patients aged 12-22 years (median = 16.6) who were attending outpatient visits for treatment of diabetes (80% type 1), inflammatory bowel disease, or cystic fibrosis completed the 9-item Patient Health Questionnaire (PHQ-9) depression and Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health measures on electronic tablets. Patients screening positive on the PHQ-9 received same-day behavioral health assessment and regular phone check-ins to facilitate necessary follow-up care. RESULTS: Overall, 89% of 122 identified patients completed screening during a 6-month window. Patients completed measures in a timely manner (within 3 minutes) without disruption to clinic flow, and they rated the process as easy, comfortable, and valuable. Depression scores varied across disease type. Patients rated lower global health relative to a previously assessed validation cohort. Depression and global health related significantly to certain medical outcomes. Fifteen percent of patients screened positive on the PHQ-9, of whom 50% confirmed attending behavioral health appointments within 6 months of screening. CONCLUSIONS: A standardized depression and global health assessment protocol implemented across pediatric subspecialties was feasible and effective. Universal behavioral health screening for adolescents and young adults living with chronic disease is necessary to meet programmatic needs in pediatric subspecialty clinics.

Stabilization of glycemic control and improved quality of life using a shared medical appointment model in adolescents with type 1 diabetes in suboptimal control.

BACKGROUND: Declining glycemic control in type 1 diabetes (T1D) during adolescence persists despite treatment advances. Non-adherence, peer relations, diabetes burnout, risk taking, transition to autonomy, family conflict, and poor quality of life (QOL) are recognized barriers. Shared medical appointments (SMAs) in adolescent T1D may offer benefits, but data are limited. Our objective was to determine whether SMAs, with multi-component interventions utilizing multidisciplinary teams, improve glycemic control and psychosocial outcomes in poorly controlled adolescent T1D. METHODS: SMAs focused on self-management, communication skills, goal setting, glucose pattern recognition, and peer/diabetes team support. SMAs included: individual history and physical, labs, surveys, multidisciplinary educational ice breakers, group session, and individual wrap up. Outcomes were QOL, adherence, and retrospective and prospective glycemic control. Three to six subjects and families came to 3 SMAs and 1 individual appointment every 3 months over 9 months. SUBJECTS: A total of 37 English speaking subjects, ages 12-16 yrs, with T1D ≥ 1 year, and hemoglobin A1c (HbA1c) 7.5-11% enrolled. Thirty-two subjects attended 75% of visits, meeting inclusion criteria. RESULTS: HbA1c worsened in the 9 months before study (ΔHbA1c= 0.7 ± 1.2; p < 0.01), but remained stable during study (ΔHbA1c = 0.01 ± 1.2; p > 0.05). There were significant improvements in overall QOL (p = 0.005), school function (p = 0.006), psychosocial function (p = 0.008), barriers (p = 0.02), adherence (p = 0.01), and communication (p = 0.02). Improvements in school function and communication reached clinical significance. CONCLUSION: SMAs are feasible replacements to individual appointments in adolescent T1D, stabilizing glycemic control and improving QOL. Randomized controlled trials with optimizations are needed to further explore and refine this intervention.

Novel homozygous likely-pathogenic intronic variant in INS causing permanent neonatal diabetes in siblings.

Permanent neonatal diabetes (PNDM) is a rare genetic condition characterized by hyperglycemia, insulinopenia, and failure to thrive beginning in the first 6 months of life. Recessive mutations in INS lead to decreased production of insulin via a variety of mechanisms. We present a case of two brothers, born to consanguineous parents, with a novel homozygous intronic variant in the INS gene. Each patient presented with intrauterine growth restriction (IUGR) and significant hyperglycemia within the first 24 h of life. All the grandparents have a diagnosis of diabetes, one of them requiring insulin treatment and the parents currently deny personal histories of diabetes. Although this mutation has not previously been described, given the segregation of the mutation, absence of heterozygosity (AOH) in the genomic region encompassing the INS locus, documented insulinopenia, and high neonatal insulin requirements, we suspect that this variant is pathogenic. Possible implications for personalized treatment of the underlying molecular etiology for an individual's diabetes are discussed.

Development of a novel hybrid strategy for transcatheter pulmonary valve placement in patients following transannular patch repair of tetralogy of fallot.

BACKGROUND: Transcatheter pulmonary valve replacement (tPVR) is an accepted therapy for treatment of dysfunctional right ventricular outflow tract (RVOT) conduits. At present, the majority of Fallot patients who undergo transannular patch (TAP) repair are not candidates for tPVR due to the large irregular nature of their RVOT. Herein, we describe a novel approach to assessing the RVOT in this group, which may then be used to design, test, and carry out hybrid RVOT modification and transcatheter valve implantation in this population. METHODS: A retrospective analysis of TAP patients who underwent 3D modeling of the RVOT which was then used to develop individualized hybrid procedures designed to modify the RVOT, thereby rendering patients suitable for transcatheter valve implantation. RESULTS: Eight consecutive patients underwent 3D RVOT modeling followed by hybrid implantation of a transcatheter valve via a perventricular approach. A landing zone stent was placed in all and four required additional intravascular geometric remodeling of the RVOT prior to valve implant. Transcatheter valves were successfully implanted in all. There were no instances of valve malposition, embolization, or death. There was one minor procedural complication. No patient had more than trivial pulmonary regurgitation at follow-up. CONCLUSIONS: Using a hybrid approach to remodel the RVOT in TAP patients supported by preprocedural 3D-model planning allows for successful tPVR implantation in this population. A larger cohort and longer follow-up will be needed to determine the ultimate utility of this approach.

Prevalence of cardiovascular risk factors in youth with type 1 diabetes and elevated body mass index.

AIM: The prevalence of cardiovascular risk factors in children with type 1 diabetes and elevated BMI in the USA is poorly defined. We aimed to test the hypothesis that children with type 1 diabetes who are overweight or obese have increased frequencies of hypertension, dyslipidemia, and micro-/macroalbuminuria compared to their healthy weight peers. METHODS: We studied 11,348 children 2 to <18 years of age enrolled in T1D Exchange between September 2010 and August 2012 with type 1 diabetes for ≥1 year and BMI ≥ 5th age-/sex-adjusted percentile (mean age 12 years, 49 % female, 78 % non-Hispanic White). Overweight and obesity were defined based on Centers for Disease Control and Prevention criteria. Diagnoses of hypertension, dyslipidemia, and micro-/macroalbuminuria were obtained from medical records. Logistic and linear regression models were used to assess factors associated with weight status. RESULTS: Of the 11,348 participants, 22 % were overweight and 14 % obese. Hypertension and dyslipidemia were diagnosed in 1.0 % and 3.8 % of participants, respectively; micro-/macroalbuminuria was diagnosed in 3.8 % of participants with available data (n = 7,401). The odds of either hypertension or dyslipidemia were higher in obese than healthy weight participants [OR 3.5, 99 % confidence interval (CI) 2.0-6.1 and 2.2, 99 % CI 1.6-3.1, respectively]. Obese participants tended to be diagnosed with micro-/macroalbuminuria less often than healthy weight participants (OR 0.6, 99 % CI 0.4-1.0). CONCLUSIONS: Obese children with type 1 diabetes have a higher prevalence of hypertension and dyslipidemia than healthy weight children with type 1 diabetes. The possible association of obesity with lower micro-/macroalbuminuria rates warrants further investigation.

Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial.

IMPORTANCE: Previous studies assessing the effect of metformin on glycemic control in adolescents with type 1 diabetes have produced inconclusive results. OBJECTIVE: To assess the efficacy and safety of metformin as an adjunct to insulin in treating overweight adolescents with type 1 diabetes. DESIGN, SETTING, AND PARTICIPANTS: Multicenter (26 pediatric endocrinology clinics), double-blind, placebo-controlled randomized clinical trial involving 140 adolescents aged 12.1 to 19.6 years (mean [SD] 15.3 [1.7] years) with mean type 1 diabetes duration 7.0 (3.3) years, mean body mass index (BMI) 94th (4) percentile, mean total daily insulin 1.1 (0.2) U/kg, and mean HbA1c 8.8% (0.7%). INTERVENTIONS: Randomization to receive metformin (n = 71) (≤2000 mg/d) or placebo (n = 69). MAIN OUTCOMES AND MEASURES: Primary outcome was change in HbA1c from baseline to 26 weeks adjusted for baseline HbA1c. Secondary outcomes included change in blinded continuous glucose monitor indices, total daily insulin, BMI, waist circumference, body composition, blood pressure, and lipids. RESULTS: Between October 2013 and February 2014, 140 participants were enrolled. Baseline HbA1c was 8.8% in each group. At 13-week follow-up, reduction in HbA1c was greater with metformin (-0.2%) than placebo (0.1%; mean difference, -0.3% [95% CI, -0.6% to 0.0%]; P = .02). However, this differential effect was not sustained at 26-week follow up when mean change in HbA1c from baseline was 0.2% in each group (mean difference, 0% [95% CI, -0.3% to 0.3%]; P = .92). At 26-week follow-up, total daily insulin per kg of body weight was reduced by at least 25% from baseline among 23% (16) of participants in the metformin group vs 1% (1) of participants in the placebo group (mean difference, 21% [95% CI, 11% to 32%]; P = .003), and 24% (17) of participants in the metformin group and 7% (5) of participants in the placebo group had a reduction in BMI z score of 10% or greater from baseline to 26 weeks (mean difference, 17% [95% CI, 5% to 29%]; P = .01). Gastrointestinal adverse events were reported by more participants in the metformin group than in the placebo group (mean difference, 36% [95% CI, 19% to 51%]; P < .001). CONCLUSIONS AND RELEVANCE: Among overweight adolescents with type 1 diabetes, the addition of metformin to insulin did not improve glycemic control after 6 months. Of multiple secondary end points, findings favored metformin only for insulin dose and measures of adiposity; conversely, use of metformin resulted in an increased risk for gastrointestinal adverse events. These results do not support prescribing metformin to overweight adolescents with type 1 diabetes to improve glycemic control. TRIAL REGISTRATION: clinicaltrials.org Identifier: NCT01881828.