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To investigate whether an increased bolus: basal insulin ratio (BBR) with liver-targeted bolus insulin (BoI) would increase BoI use and decrease hypoglycaemic events (HEv).We enrolled 52 persons (HbA1c 6.9% ± 0.12%, mean ± SEM) with type 1 diabetes using multiple daily injections. Hepatic-directed vesicle (HDV) was used to deliver 1% of peripheral injected BoI to the liver. A 90-day run-in period was used to introduce subjects to unblinded continuous glucose monitoring and optimize standard basal insulin (BaI) (degludec) and BoI (lispro) dosing. At 90 days, BoI was changed to HDV-insulin lispro and subjects were randomized to an immediate 10% or 40% decrease in BaI dose.At 90 days postrandomization, total insulin dosing was increased by ~7% in both cohorts. The -10% and -40% BaI cohorts were on 7.7% and 13% greater BoI with 6.9% and 30% (P = .02) increases in BBR, respectively. Compared with baseline at randomization, nocturnal level 2 HEv were reduced by 21% and 43%, with 54% and 59% reductions in patient-reported HEv in the -10% and -40% BaI cohorts, respectively.Our study shows that liver-targeted BoI safely decreases HEv and symptoms without compromising glucose control. We further show that with initiation of liver-targeted BoI, the BBR can be safely increased by significantly lowering BaI dosing, leading to greater BoI usage.

OBJECTIVETo assess the prevalence of high diabetes distress and associated factors in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY2) study cohort of young adults with youth-onset type 2 diabetes.RESEARCH DESIGN AND METHODSParticipants completed the Diabetes Distress Scale (DDS) at end-of-study visits. Factors examined for association with high distress were demographic (sex, race/ethnicity, age, education, income), medical (HbA1c, BMI, complications), psychological (depressive and anxiety symptoms), and social (number in household, offspring, health care coverage, established with diabetes care provider). Univariate logistic regression identified factors associated with high distress that were controlled for in multivariate logistic regressions.RESULTSOf 438 participants, 66% were female (mean age 26.8 years, 18% non-Hispanic White, 37% non-Hispanic Black, 38% Hispanic). High distress (DDS ≥2) was reported by 105 (24%) participants. Subscales identified 40% with high regimen distress and 29.7% with high emotional burden. A greater percentage of those with high distress were female (P = 0.002), diagnosed with hypertension (P = 0.037) and retinopathy (P = 0.005), treated with insulin, had higher HbA1c, and had moderate to severe depressive and anxiety symptoms (all P < 0.001). In multivariate analyses, female sex (P < 0.001), HbA1c (P < 0.001), anxiety symptoms (P = 0.036), and lack of health care coverage (P = 0.019) were associated with high distress, after controlling for potential confounders. Moderate to severe depressive symptoms were associated with high regimen distress (P = 0.018) and emotional burden (P < 0.001); insulin treatment was associated with high emotional burden (P = 0.027).CONCLUSIONSFuture research should identify modifiable factors associated with high diabetes distress in young adults with youth-onset type 2 diabetes that may inform distress interventions with this medically vulnerable group.

Background The prevalence of depression amongst adolescents with type 1 diabetes is estimated to be 2-3 times higher than in the general population. In adults with type 1 diabetes and depression short-term outcomes are worse compared to individuals just diagnosed with type 1 diabetes. This study aims to determine if depressive symptom endorsement is associated with glycemic outcomes and short-term complications in adolescents with type 1 diabetes. Methods Analysis was conducted using electronic medical records from the T1D Exchange Quality Improvement Collaborative. Adolescents with type 1 diabetes, aged 12-18, receiving treatment in a diabetes clinic who had been screened for depression with the PHQ-9 between 2016-2018 were eligible for inclusion. Individuals must have also had HbA1c data available from the day of depression screening and from 10-24 weeks after screening; the final sample size was 1,714. Results Almost 30% of adolescents endorsed mild or greater (PHQ-9 ≥ 5) depressive symptoms. Endorsement of mild or greater depressive symptoms was associated with an 18% increased risk of an HbA1c ≥7.5% and a 42% increased risk of an HbA1c ≥9.0% on the day of screener administration. Depressive symptom endorsement was also associated with an 82% increased risk for DKA. Conclusions This study suggests that depression symptoms are associated with an increased risk for elevated HbA1c and short-term complications. With the rising incidence of type 1 diabetes in youth, routine screening, and appropriate management of depression is needed. This article is protected by copyright. All rights reserved.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycaemia, behavioural considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that healthcare professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors. [Figure not available: see fulltext.]

OBJECTIVE Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. RESEARCH DESIGN AND METHODS This single-arm, multicenter, prospective study enrolled 112 children (age 6–13.9 years) and 129 adults (age 14–70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70–180 mg/dL (“time in range”). RESULTS A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia CONCLUSIONS This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia.

Glycemic outcomes of adults with type 1 diabetes may be affected by depression. Our aim was to compare outcomes of “depressed” (Patient Health Questionnaire-9 ⩾ 10, N = 83) to “not-depressed” matched control (Patient Health Questionnaire-2 < 3, N = 166) adults with type 1 diabetes with objective measures. The depressed group had poorer blood glucose control and, for those with glucose meter downloads, fewer glucose tests/day. The groups did not differ on glucose variability or episodes of hypoglycemia. Depression in adults with type 1 diabetes is associated with poorer glycemic control and less blood glucose monitoring. Future research should examine whether treatment of depression results in better self-care and glycemic outcomes.

This article describes how the T1D Exchange Quality Improvement Collaborative leverages an innovative web platform, the QI Portal, to gather and store electronic medical record (EMR) data to promote benchmarking and population health improvement in a type 1 diabetes learning health system. The authors explain the value of the QI Portal, the process for mapping center-level data from EMRs using standardized data specifications, and the QI Portal’s unique features for advancing population health.

To assess associations of psychosocial factors with medication adherence in young adults with youth-onset type 2 diabetes in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) cohort.Participants (mean age 26 years) completed validated psychosocial measures. Adherence to oral hypoglycemia agents (OHAs) was assessed with 3-monthly unannounced phone pill counts; insulin adherence by self-report. Logistic and linear regressions identified factors associated with "low-adherence" (80% of pills/insulin) controlling for confounders.Of 212 participants taking OHAs (67% female, 39% Hispanic, 36% non-Hispanic Black), 69.8% were low-adherent. After adjustment, beliefs that medicines are necessary was associated with lower odds of low-adherence (p = 0.040, dichotomous). Less self-management support (p = 0.008), no healthcare coverage (p = 0.001), ≥1 (p = 0.008)/≥2 (p = 0.045) need insecurities were associated with higher odds of low-adherence. Factors associated with lower % adherence (continuous) were beliefs that medicines are harmful (p 0.001)/overused (p = 0.007)/less necessary (p = 0.022), low self-management support (p = 0.003), food insecurity (p = 0.036), no healthcare coverage (p 0.001), ≥1 (p = 0.003)/≥2 (p = 0.018) need insecurities. Of 192 taking insulin (69% female, 36% Hispanic, 41% non-Hispanic Black, 16% non-Hispanic white), 37.0% were low-adherent. Beliefs that medicines are overused (p = 0.009), that diabetes is not serious (p = 0.010), low diabetes self-efficacy (p = 0.035), high distress (p = 0.027), low self-management support (p = 0.001), food insecurity (p = 0.020), ≥1 (p = 0.011)/≥2 (p = 0.015) insecurities increased odds of insulin low-adherence.Poor medication adherence, common in young adults with youth-onset type 2 diabetes, is associated with interfering beliefs, diabetes distress and social factors. We must address these factors to develop tailored interventions for this vulnerable group.

AIMS: To test whether a long-acting GLP-1 receptor agonist would improve glucose control in patients with type 1 diabetes (T1D) and to determine whether the presence of residual beta cell function would affect the response. In addition, we sought to determine whether the drug would affect beta cell function. METHODS: We performed a randomized placebo-controlled trial of exenatide extended release (ER) in participants with T1D with and without detectable levels of C-peptide. Seventy-nine participants were randomized to exenatide ER 2 mcg weekly, or placebo, stratified by the presence or absence of detectable C-peptide levels. The primary outcome was the difference in glycated haemoglobin (HbA1c) levels at 24 weeks. Participants were followed for another 6 months off study drug. RESULTS: At week 24, the time of the primary outcome, the least squares (LS) mean HbA1c level was 7.76% (95% confidence interval [CI] 7.42, 8.10) in the exenatide ER group versus 8.0% (95% CI 7.64, 8.35) in the placebo group (P = 0.08). At week 12 the LS mean HbA1c levels were 7.71% (95% CI 7.37, 8.05) in the exenatide ER group versus 8.05% (95% CI 7.7, 8.4) in the placebo group (P = 0.01). The improvement at week 12 was driven mainly by those with detectable levels of C-peptide. Those treated with exenatide ER lost weight at 12 and 24 weeks compared to those treated with placebo (P

AIM To examine the control of cardiovascular risk factors in type 1 diabetes (T1D) registries from the United States and Germany/Austria. MATERIALS AND METHODS Data on individuals aged ≥12 years with T1D for ≥1 year, from the T1D Exchange Clinic Network (T1DX, United States) and the Prospective Diabetes Follow-up Registry (DPV, Germany/Austria) from 1 January 2016 to 31 March 2018 were analysed. Linear and logistic regression models adjusted for age groups, sex, duration of diabetes and minority status were used to compare clinical characteristics and achievement of diabetes management targets between registries. RESULTS The cohort consisted of 47 936 patients (T1DX, n = 19 442; DPV, n = 28 494). Achievement of HbA1c goals (

There is a growing population of adults over the age of 65 years with T1DM, but their lived experiences have not been well-characterized, especially in the context of evolving advances in self-management technology. We conducted focus groups with adults 65+ yrs with T1DM to characterize their perspectives surrounding T1DM and its management, focusing on CGM experiences. Participants were recruited from a US academic medical center and encouraged to bring a caregiver. Focus groups were stratified by CGM use, facilitated by standardized questions, audiotaped and transcribed. A team-based, inductive coding approach using ATLAS.ti identified themes. There were 33 adults (mean age 73.3±4.3 years [range 66-85]; 55% women, 82% non-Hispanic white, 12% non-CGM users, 83% pump users, 12% caregivers) . Five CGM-related themes were identified from all participants, including adoption challenges and complex clinical and psychosocial effects (Table) . Caregiver participants emphasized increased security with CGM use. Patient participants expressed a prevalent “survivor” mentality and a desire for increased peer support and strategies to minimize intrusiveness of T1DM management. Findings reinforce that older adults’ experiences with T1DM and CGM necessitate individualized psychosocial and tactical support for management and adoption of new technology. Disclosure A.Kahkoska: None. L.A.Young: Research Support; Bayer AG, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, vTv Therapeutics. K.Hassmiller lich: None. A.Cristello: None. C.Smith: None. S.R.Thomas: None. J.Batsis: None. E.J.Mayer-davis: None. M.R.Kosorok: n/a. R.E.Pratley: Other Relationship; Bayer AG, Corcept Therapeutics, Dexcom, Inc., Hanmi Pharm. Co., Ltd., Merck & Co., Inc., Metavention, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. R.S.Weinstock: Research Support; Boehringer Ingelheim International GmbH, Dexcom, Inc., Diasome, Eli Lilly and Company, Insulet Corporation, Kowa Pharmaceuticals America, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care, Inc., Tolerion, Inc. Funding ARK is supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant KL2TR002490. The project was supported by UL1TR002489 from the Clinical and Translational Science Award program of the Division of Research Resources, National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Aim: To identify psychosocial factors in young adults (mean age 26 yrs) that predict medication adherence 1 year later in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY2) observational study. Methods: Validated psychosocial measures (attitudes, beliefs, self-efficacy, distress, depression, anxiety, self-management support, needs insecurities) were completed at baseline (T1) . Medication adherence was assessed at T1 and 1 year later (T2) . Adherence to oral hypoglycemia agents (OHA) was assessed with 3 monthly unannounced phone pill counts. Insulin adherence was self-report. Adherence was defined categorically (≥ 80% pills/insulin=high adherent; < 80% = low adherent) and continuously (% adherence) . Logistic and linear regressions assessed psychosocial measures as predictors of adherence group (high vs. low) and % adherence, controlling for potential confounders. Results: OHA adherence: Mean scores declined from T1 to T2 (57.9% vs. 51.4%, p=0.004; N=171) . In adjusted multivariable analyses, more concerns about diabetes medications (e.g. long-term effects) (p=0.035) and lack of healthcare coverage (p=0.043) predicted higher odds of being low adherent. Beliefs that medications are harmful (p=0.004) or overused (p=0.002) , lack of healthcare coverage (p Conclusions: Negative beliefs about medicines and unmet material needs predicted poorer OHA adherence. Negative beliefs, low support and distress predicted lower insulin adherence. These factors may be targets for future interventions. Disclosure P.M.Trief: None. S.Kalichman: None. D.Uschner: None. L.M.Fette: None. H.Wen: None. K.Drews: None. B.Anderson: None. J.D.Bulger: None. R.S.Weinstock: Research Support; Boehringer Ingelheim International GmbH, Dexcom, Inc., Diasome, Eli Lilly and Company, Insulet Corporation, Kowa Pharmaceuticals America, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care, Inc., Tolerion, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (RO1DK110456, U01-DK61212, U01-DK61230, U01-DK61239, U01-DK61242, and U01-DK61254)

While diabetes and admission blood glucose (BG) are established risk factors for adverse outcomes during hospitalization for COVID-19, reports on the impact of prior glycemic control have been variable. We examined the relationship between acute and chronic glycemia on risk of ICU admission, mechanical ventilation (MV) , and mortality among 1,786 patients with diabetes or hyperglycemia (BG > 180 mg/dl twice during any 24-hr period during hospitalization) admitted from March 2020 to February 2021 with COVID-at 5 large university hospitals in the eastern U.S. The cohort was 51.3% male, 53.3% White, 18.8% Black, 29.3% Hispanic, with age = 64.8 ± 13.8 y, BMI = 31.5 ± 7.9 kg/m2, admission BG = 216 ± 134 mg/dl, and HbA1c = 8.1 ± 2.2%. During hospitalization, 38.9% were admitted to the ICU, 22.9% received MV, and 10.6% died. In multivariate regression analysis, among demographic factors, age was the strongest risk factor for in-hospital mortality (OR = 1.per year [95% CI: 1.04, 1.06]) , and Hispanic ethnicity was the greatest risk factor for ICU admission (OR = 1.45 [95% CI: 1.16, 1.80]) and intubation (OR = 1.64 [95% CI: 1.28, 2.10]) . Higher BMI (p = 0.005) and admission BG (p = 0.014) were associated with increased risk of mortality, but HbA1c was not. The glycemic gap (GG) , defined as admission BG minus estimated average BG based on HbA1c, was a stronger predictor of mortality than either admission BG or HbA1c alone. Mortality rate was 5.7% for GG < -20 mg/dl; 12.2% for GG = -20 to < 20 mg/dl; 12.4% for GG = 20 to < 100 mg/dl; and 16.1% for GG ≥ 100 mg/dl (p for trend < 0.001) . Conclusion: Among patients with diabetes or hyperglycemia admitted for COVID-19, in addition to previously established risk factors for poor outcomes (age, Hispanic ethnicity, and BMI) , we found that GG is a stronger predictor of in-hospital mortality than blood glucose alone. This suggests that relative hyperglycemia, as measured by the admission GG, is an important marker of disease severity in COVID-and potentially other serious illnesses. Disclosure M.E.Mcdonnell: Advisory Panel; Everlywell, Inc., Research Support; Lilly, Stock/Shareholder; Abbott Diabetes. G.P.Westcott: None. D.C.Simonson: Stock/Shareholder; GI Windows, Phase V Technologies, Inc. G.Gopalakrishnan: Research Support; Eli Lilly and Company, Spruce Biosciences. R.Garg: None. J.Mitri: Consultant; dairy management, Lnutra. R.S.Weinstock: Research Support; Boehringer Ingelheim International GmbH, Dexcom, Inc., Diasome, Eli Lilly and Company, Insulet Corporation, Kowa Pharmaceuticals America, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care, Inc., Tolerion, Inc. M.Greenfield: None. N.E.Palermo: Research Support; Dexcom, Inc. R.Radhakrishnan: None. Funding Brigham-TechFoundation, Cambridge, MA 2021

To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System.A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses.Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70-180 mg/dL, percent time below range 70 mg/dL, hemoglobin A1c, or insulin regimen).Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D.NCT04196140.

To understand the relationship of obesity and 27 circulating inflammatory biomarkers to the prevalence of non-proliferative diabetic retinopathy (NPDR) in youth with type 2 diabetes.Youth with type 2 diabetes who participated in the TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study were followed for 2-6.5 years. Digital fundus photographs were obtained in the last year of the study. Blood samples during the study were processed for inflammatory biomarkers, and these were correlated with obesity tertiles and presence of retinopathy.Higher BMI was associated with an increase in circulating levels of metabolic biomarkers including high sensitivity C-reactive protein (hsCRP), plasminogen activator inhibitor 1 (PAI-1), fibrinogen, LDL-cholesterol (LDL-C) and Apolipoprotein B (ApoB), tumor necrosis factor receptors 1 and 2 (TNFR-1 and -2), interleukin 6 (IL-6), E-selectin, and homocysteine, as well as a decrease in the metabolic risk markers HDL-cholesterol (HDLC), and insulin-like growth factor binding protein 1 (IGFBP-1). Although NPDR risk decreased with increasing obesity, it was not associated with any of the measured biomarkers.Circulating levels of measured biomarkers did not elucidate the "obesity paradox" of decreased NPDR in the most obese participants in the TODAY study.clinicaltrials.govNCT00081328.

Project ECHO® is a telementoring workforce development model that targets under-resourced communities lacking access to specialty care. The model builds virtual communities of practice, including specialists and community primary care professionals (PCPs) to combat clinical inertia and health disparities. While the ECHO model has gained global recognition, implementation of the model related to diabetes is lagging compared to other specialty conditions. This review highlights diabetes-endocrine (ENDO)-focused ECHOs using data reported in the ECHO Institute’s centralized data repository (iECHO) and the learning collaborative for diabetes ECHOs. It also describes the implementation of diabetes ECHOs and their evaluation. Learner and patient-centered outcomes related to diabetes ECHOs are reviewed. Program implementation and evaluations have demonstrated utility of the ECHO model for diabetes programs to (1) address unmet needs of diabetes care in the primary care setting, (2) improve knowledge and confidence in managing complex diabetes and change provider prescribing habits, (3) improve patient outcomes, and (4) address diabetes quality improvement practices in primary care. More studies with broader collaboration among sites are needed to evaluate the model related to diabetes, especially applied to addressing therapeutic inertia, adoption of diabetes technology, and reducing health disparities.

Continuous glucose monitoring (CGM) can reduce hypoglycemia in older adults with type 1 diabetes (T1D). We aimed to characterize factors that influence effective use in this age group.Older adults with type T1D (age ≥65) and their caregivers participated in one of a series of parallel group model building workshops, a participatory approach to system dynamics involving drawing and scripted group activities. Data were synthesized in a qualitative model of the hypothesized system of factors producing distinct patterns of CGM use in older adults. The model was validated through virtual follow-up interviews.Data were collected from 33 participants (four patient-caregiver dyads, mean age 73.8±4.4 years [range 66-85 years]; 16% non-CGM users, 79% pump users). The system model delineates drivers of CGM uptake, drivers of ongoing CGM use, and feedback loops that either reinforce or counteract future CGM use. Participants emphasized the importance of different sets of feedback loops at different points in the duration of CGM use.The holistic system model underscores that factors and feedback loops driving effective CGM use in older adults are both individualized and dynamic (e.g., changing over time), suggesting opportunities for staged and tailored age-specific education and support. Short title: CGM Use in Older Adults with Type 1 Diabetes.

Background: The Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) study demonstrated continuous glucose monitoring (CGM) reduced hypoglycemia over 6 months among older adults with type 1 diabetes (T1D) compared with blood glucose monitoring (BGM). We explored heterogeneous treatment effects of CGM on hypoglycemia by formulating a data-driven decision rule that selects an intervention (ie, CGM vs BGM) to minimize percentage of time Method: The precision medicine analyses used data from participants with complete data (n = 194 older adults, including those who received CGM [n = 100] and BGM [n = 94] in the trial). Policy tree and decision list algorithms were fit with 14 baseline demographic, clinical, and laboratory measures. The primary outcome was CGM-measured percentage of time spent in hypoglycemic range (Results: The optimal decision rule was found to be a decision list with 3 steps. The first step moved WISDM participants with baseline time-below range >1.35% and no detectable C-peptide levels to the CGM subgroup (n = 139), and the second step moved WISDM participants with a baseline time-below range of >6.45% to the CGM subgroup (n = 18). The remaining participants (n = 37) were left in the BGM subgroup. Compared with the BGM subgroup (n = 37; 19%), the group for whom CGM minimized hypoglycemia (n = 157; 81%) had more baseline hypoglycemia, a lower proportion of detectable C-peptide, higher glycemic variability, longer disease duration, and higher proportion of insulin pump use. Conclusions: The decision rule underscores the benefits of CGM for older adults to reduce hypoglycemia. Diagnostic CGM and laboratory markers may inform decision-making surrounding therapeutic CGM and identify older adults for whom CGM may be a critical intervention to reduce hypoglycemia.

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.

OBJECTIVE Higher serum uric acid (SUA) is associated with diabetic kidney disease (DKD). Preventing Early Renal Loss in Diabetes (PERL) evaluates whether lowering SUA with allopurinol slows glomerular filtration rate (GFR) loss in people with type 1 diabetes (T1D) and mild to moderate DKD. We present the PERL rationale, design, and baseline characteristics. RESEARCH DESIGN AND METHODS This double-blind, placebo-controlled, multicenter trial randomized 530 participants with T1D, estimated GFR (eGFR) of 40–99.9 mL/min/1.73 m2, SUA ≥4.5 m/dL, and micro- to macroalbuminuric DKD or normoalbuminuria with declining kidney function (NDKF) (defined as historical eGFR decline ≥3 mL/min/1.73 m2/year) to allopurinol or placebo. The primary outcome is baseline-adjusted iohexol GFR (iGFR) after 3 years of treatment plus a 2-month washout period. RESULTS Participants are 66% male and 84% white. At baseline, median age was 52 years and diabetes duration was 35 years, 93% of participants had hypertension, and 90% were treated with renin-angiotensin system inhibitors (median blood pressure 127/71 mmHg). Median HbA1c was 8%, SUA 5.9 mg/dL, iGFR 68 mL/min/1.73 m2, and historical eGFR slope −3.5 mL/min/1.73 m2/year. Compared with participants with albuminuria (n = 419), those with NDKF (n = 94) were significantly older (56 vs. 52 years), had lower HbA1c (7.7 vs. 8.1%) and SUA (5.4 vs. 6.0 mg/dL), and had higher eGFR (82 vs. 74 mL/min/1.73 m2) and historical eGFR loss (−4.7 vs. −2.5 mL/min/1.73 m2/year). These differences persisted when comparing groups with similar rates of historical eGFR loss. CONCLUSIONS PERL will determine the effect of allopurinol on mild to moderate DKD in T1D, with or without albuminuria. Participants with normoalbuminuria and rapid GFR loss manifested many DKD risk factors of those with albuminuria, but with less severity.

Context Use of continuous glucose monitoring (CGM) is increasing for insulin-requiring patients with diabetes. Although data on glycemic profiles of healthy, nondiabetic individuals exist for older sensors, assessment of glycemic metrics with new-generation CGM devices is lacking. Objective To establish reference sensor glucose ranges in healthy, nondiabetic individuals across different age groups using a current generation CGM sensor. Design Multicenter, prospective study. Setting Twelve centers within the T1D Exchange Clinic Network. Patients or Participants Nonpregnant, healthy, nondiabetic children and adults (age ≥6 years) with nonobese body mass index. Intervention Each participant wore a blinded Dexcom G6 CGM, with once-daily calibration, for up to 10 days. Main Outcome Measures CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability. Results A total of 153 participants (age 7 to 80 years) were included in the analyses. Mean average glucose was 98 to 99 mg/dL (5.4 to 5.5 mmol/L) for all age groups except those over 60 years, in whom mean average glucose was 104 mg/dL (5.8 mmol/L). The median time between 70 to 140 mg/dL (3.9 to 7.8 mmol/L) was 96% (interquartile range, 93 to 98). Mean within-individual coefficient of variation was 17 ± 3%. Median time spent with glucose levels >140 mg/dL was 2.1% (30 min/d), and median time spent with glucose levels Conclusion By assessing across age groups in a healthy, nondiabetic population, normative sensor glucose data have been derived and will be useful as a benchmark for future research studies.

OBJECTIVE Elevated serum uric acid (SUA) is increasingly recognized as a risk factor for kidney disease in adults with diabetes, but data in youth are limited. We hypothesized that elevated SUA predicts development of elevated urinary albumin excretion (UAE) and hypertension over time in teens with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS Serum creatinine, cystatin C, SUA, and the urine albumin-to-creatinine ratio (UACR) were assessed in 539 obese youth, ages 12–17 years, with T2D duration RESULTS At baseline, hyperuricemia (≥6.8 mg/dL) was present in 25.6% of participants, hypertension in 18.7%, and elevated UAE in 6.1%. During follow-up of up to 7 years, hypertension developed in 37.4% and UAE in 18.0%. Higher baseline SUA increased the risk of incident hypertension (hazard ratio [HR] 1.19, 95% CI 1.03–1.38, per 1 mg/dL increase in SUA) and elevated UAE (HR 1.24, 95% CI 1.03–1.48) in adjusted models. CONCLUSIONS Hyperuricemia was common in youth with T2D. Higher baseline SUA independently increased the risk for onset of hypertension and elevated UAE. Research is needed to determine whether SUA-lowering therapies can impede development of diabetic kidney disease and hypertension in T2D youth.

People with diabetes (DM) hospitalized with COVID-19 infection have a 2-3 fold higher risk of death compared with those without DM, and mechanical ventilation (MV) has been identified as a major risk factor for death. While stress hyperglycemia (StH) has been established as a risk factor for death in some critically ill cohorts, it is not a well-established risk factor for MV in COVID-19. The COVIDEastDM consortium pooled data from 5 academic hospitals on the East Coast of the US to study the relationship between hyperglycemia and COVID-19 outcomes. Data were obtained retrospectively from electronic records of adults with COVID-19 and either DM or StH (defined in this cohort as day-1 admission blood glucose >180 mg/dl and A1c Disclosure M. E. Mcdonnell: Stock/Shareholder; Spouse/Partner; Abbott Diabetes. N. E. Palermo: None. R. Radhakrishnan: None. G. P. Westcott: None. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. R. Garg: None. D. C. Simonson: Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc. G. Cromwell: None. G. Gopalakrishnan: None. M. Greenfield: None. M. Johnson: None. S. R. Katta: None. J. Lebastchi: None. J. Mitri: Consultant; Self; L-Nutra. Funding TechFoundation; Brigham Education Institute

Aims: Diabetes distress (DD) is associated with poor health outcomes. Little is known about level of DD in young adults (YAs) with youth-onset type 2 diabetes (T2D) or individual factors associated with DD. Aims were to assess level of DD, and factors associated with high DD, in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) cohort. Methods: YAs completed the Diabetes Distress Scale (DDS), PHQ-9 (depressive symptoms) and GAD7 (anxiety), at the end-of-study visit. Factors that may relate to DD were demographics (sex, race/ethnicity, age, education, income), medical history (HbA1c, BMI, complications), and social/economic factors (# persons in household, parent status, healthcare coverage, access to diabetes care provider). Univariate logistic regressions found factors associated with high DD. Multivariate regression controlled for sex, HbA1c, healthcare coverage, anxiety, depressive symptoms and retinopathy. Results: Of 457 YAs, mean age=26.7 yrs, 65% were female, 20% non-Hispanic white, 38% non-Hispanic Black, 20% Hispanic, 62% Conclusion: In young adults with youth-onset T2D, high DD was significantly more likely in females, and those with anxiety, high HbA1c, and without healthcare coverage. Disclosure P. M. Trief: None. M. S. Rayas: Research Support; Self; National Center for Advancing Translational Sciences. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. D. Uschner: None. M. Tung: None. L. Chao: None. R. M. Farrell: Stock/Shareholder; Self; Tandem Diabetes Care. J. Keady: None. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. M. D. Marcus: Advisory Panel; Self; Weight Watchers International, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK61212, U01DK61230, U01DK61239, U01DK61242, U01DK61254)

Background: Medication adherence is poor in young adults (YAs) with youth-onset type 2 diabetes (T2D). Little is known about intrapersonal factors that may relate to adherence. Aims: To assess associations of intrapersonal factors to medication adherence in Treatment Options for Adolescents and Youth (TODAY2) YAs. Methods: Validated measures (attitudes, beliefs, self-efficacy, distress, depression, anxiety) and insulin use surveys, were completed at a TODAY2 visit. Adherence to oral hypoglycemia agents (OHAs) was assessed with 3 monthly unannounced phone pill counts. Those taking ≥ 80% of pills/insulin classified “high-adherent;” < 80% of pills/insulin, “low-adherent.” If taking none, reasons were queried and adjudicated (no need vs. low-adherent). Logistic regressions assessed factors associated with OHA/insulin adherence controlling for gender, race/ethnicity, education, duration, healthcare coverage, and HbA1c. Results: Of 381 YAs in iCount (mean age 26 yrs, 68% female, 20% non-Hispanic white, 38% non-Hispanic Black, 36% Hispanic, 64.9% Conclusion: Poor medication adherence is common in YAs with youth-onset T2D. More needs to be learned about factors associated with adherence to develop tailored, effective interventions. Disclosure P. M. Trief: None. D. Uschner: None. M. Tung: None. K. Drews: None. S. Kalichman: None. B. Anderson: None. J. D. Bulger: None. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1RO1DK110456-01A1; U01DK61230)

Background: Satisfaction with televisits across age groups has not been well studied. Aim: To evaluate patient satisfaction with remote diabetes self-management education and support (DSMES) throughout adulthood. Methods: Surveys were administered electronically to patients with type 1 (T1D) or type 2 diabetes who had completed at least one remote education visit. Televisits were conducted without charge by a CDCES who had no prior relationship with the patient. If there was no response to the emailed survey within one week or an email address was unavailable the survey was conducted by phone. Survey questions used a 5-point Likert scale (1-strongly disagree to 5-strongly agree). Data were analyzed using t-test to assess differences in means, and Pearson correlation coefficients to assess relationship between Likert scaled items and age. SPSS v. 27 was used. Results: N=200 surveys were completed (45 by email, 155 by phone). Response rate was 37.9%. Mean age 52.5 years (range 21-82), 56% female, 78.5% T1D, 45.5% private insurance, 36% Medicare, 18% Medicaid, mean HbA1c 8.0% (SD 1.6). Correlation between mean score and age are shown in the table. Medicaid recipients were more likely to agree with “In the past, cost was a barrier to receiving diabetes education” compared to those with private insurance (p=0.005). Conclusions: Satisfaction with remote DSMES was less in older adults. Studies of remote DSMES tailored to older adults are needed. Disclosure C. Feuerstein-simon: None. M. Greenfield: None. P. Saha: None. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. Funding The Leona M. and Harry B. Helmsley Charitable Trust; T1D Exchange QI Learning Collaborative

Aim: To understand how remote Certified Diabetes Care and Education Specialists (CDCES) helped adults with type 1 diabetes (T1D) transition from provider in-person to tele-visits. Methods: Adults with T1D were referred to remote CDCES to fulfill needs from 4/16/2020 - 8/14/2020. Pertinent information from the EMR was provided to the CDCES who were not previously known to the patients. A summary of the remote CDCES encounter was communicated to the provider. Data analysis used t-tests to assess differences in means and Pearson correlation coefficients to assess relationship between the number of encounters and insurance and age. SPSS v. 27 was used. Results: Adults (n=1089) with T1D [mean age 46 (range 18-90 yrs); 50% female; 20% Medicaid, 23% Medicare, 54% private coverage; mean A1c 8.4% (range 4.6 to >14.0%); 52% pump and 61% CGM users], had 1662 encounters with remote CDCES. Of those referred, 232 (21%) could not be reached or did not receive education/support. Older age was associated with more encounters (r=0.126, p Conclusions: Most remote CDCES encounters in adults with T1D were successfully completed, assisting the majority with CGM education/data review and nearly half with device download training in preparation for their provider tele-visit. Older adults and those with Medicare required more encounters to fulfill needs. Future study could assess whether remote encounters result in improved glycemic control or quality of life. Disclosure M. Greenfield: None. D. L. Stuber: None. D. Stegman-barber: None. K. Kemmis: None. B. A. Wells: None. T. S. Mcarthur: None. B. Matthews: None. C. P. Morley: None. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. Funding The Leona M. and Harry B. Helmsley Charitable Trust; T1D Exchange QI Learning Collaborative

Safe and effective use of the Omnipod 5 System was demonstrated in adults and children with type 1 diabetes (T1D) during a 3-month pivotal study. Longer studies are needed to evaluate durability of glycemic benefit. Those completing the pivotal study were invited to continue system use for an additional 12 months, with 95% enrolling in the extension. We present results from the first 3-month follow-up. Participants aged 6-70y with T1D≥6 months and A1C Disclosure A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. J. Sherr: Advisory Panel; Self; Cecelia Health, Insulet Corporation, Medtronic, Consultant; Self; Insulet Corporation, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Speaker’s Bureau; Self; Lilly Diabetes. S. N. Mehta: None. L. M. Laffel: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompe, Insulogic LLC, Janssen Pharmaceuticals, Inc., Laxmi Therapeutic Devices, LifeScan, Lilly Diabetes, Medtronic, Provention Bio, Inc. V. Shah: Advisory Panel; Self; Medscape, Sanofi, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, vTv Therapeutics. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. T. C. Jones: None. G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. A. B. Criego: Consultant; Self; Bigfoot Biomedical, Inc., Other Relationship; Self; Sanofi, Research Support; Self; Abbott Diabetes, Eli Lilly and Company, Insulet Corporation, Medtronic. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. T. Ly: Employee; Self; Insulet Corporation. Omnipod 5 research group: n/a. G. P. Forlenza: Advisory Panel; Self; Medtronic, Consultant; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. B. W. Bode: Advisory Panel; Self; Eli Lilly and Company, Consultant; Self; Bigfoot Biomedical, Inc., Companion Medical, Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Abvance Therapeutics, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Dompe, Eli Lilly and Company, Eyenuk, Inc., Insulet Corporation, Jaeb Center for Health Research, Medtro Funding Insulet Corporation

Background: Continuous glucose monitors (CGMs) help people with type 1 diabetes (T1D) improve their glycemic profiles but are underutilized. To better understand why, perceived CGM burdens and benefits in nonusers versus users with type 1 diabetes across the lifespan were assessed. Methods: Burdens (BurCGM) and benefits of CGM (BenCGM) questionnaires were completed during T1D outpatient visits ( n = 1334) from February 2019 to February 2020. Mean scores were calculated (scale one to five; higher scores reflect greater perceived burdens/benefits). Data were collected from medical records including glycated hemoglobin (HbA1c) within 3 months of the visit. Results: Individuals of all ages using CGM described more benefits and less burdens (mean scores 4.48 and 1.69, respectively) when compared with those who were not using CGM (mean score 4.19 and 2.35, respectively) ( P < .001). There were no differences in burdens or benefits by sex. Non-CGM users aged ≥50 years had higher mean BurCGM scores than those aged Conclusions: CGM was perceived as having more burdens and less benefits in nonusers, with differences in concerns varying across the lifespan. Lower costs and age-appropriate education are needed to address these barriers.

OBJECTIVE To determine whether self-monitoring of blood glucose (SMBG) is associated with lower HbA1c in youth with type 2 diabetes taking oral medications only or after starting insulin for persistently elevated HbA1c. RESEARCH DESIGN AND METHODS Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study participants (n = 699) taking oral medications were asked to perform SMBG twice daily. After reaching primary outcome (PO) (HbA1c ≥8% [64 mmol/mol]) over 6 months or an inability to wean from temporary insulin because of metabolic decompensation), insulin glargine was started. HbA1c and percent of SMBG (SMBG%) (percent days when the meter was used one or more times) before and after PO were analyzed. RESULTS SMBG declined over time and was inversely related to HbA1c (P < 0.0001). Of 298 youth who reached PO and started insulin, 282 had SMBG data. At PO, mean ± SD age was 15.8 ± 2.3 years, BMI 35.5 ± 7.9 kg/m2, and HbA1c 9.6 ± 2.0% (81 ± 21.9 mmol/mol); 65.3% were female. Median SMBG% was 40% at PO, which increased to 49% after 6 months and fell to 41% after 1 year on insulin. At PO, 22% of youth checked ≥80% of days, which increased to 25% and fell to 19% after 6 and 12 months using insulin, respectively. At PO, compared with those who checked CONCLUSIONS Low SMBG adherence was common and associated with higher HbA1c. Optimal SMBG frequency in youth using or not using insulin, and whether less frequent SMBG is a marker for overall worse self-care, require further study.

T2D in adolescents is associated with an unfavorable lipid profile, but data on lipoprotein particle size and distribution in this population have yet to be published. The TODAY Study, a randomized treatment trial of T2D in youth, provided the opportunity to evaluate lipoprotein particle distribution and relate lipoprotein particle number and size to HbA1C, need for insulin treatment, gender, race/ethnicity, BMI, and blood pressure (BP). TODAY participants (n=348) with yearly samples available for NMR Lipoprofile assessments (baseline, 12, 24, 36 mos) were included. Baseline participant characteristics (mean±SD) were: age 13.7±2.0 yrs; BMI 34.3±7.6 kg/m2; 62.4% female; 20.7% White, 32.2% Non-Hispanic Black (NHB), 43.7% Hispanic. Analysis demonstrated increasing numbers of LDL, HDL, and VLDL particles over the three yrs (all ps In conclusion, these data demonstrate an atherogenic lipoprotein phenotype in youth with T2D and strong relationships with glycemic control and other cardiac risk factors. Concern regarding premature development of atherosclerosis in youth with T2D is warranted. Disclosure L.E. Katz: None. J.D. Otvos: Employee; Self; LabCorp. K. Drews: None. B. Tesfaldet: None. F. Bacha: Research Support; Self; AstraZeneca, Takeda Development Center Americas, Inc. S.M. Willi: Advisory Panel; Self; Boehringer Ingelheim International GmbH. Research Support; Self; Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Tolerion, Inc. Other Relationship; Self; Caladrius Biosciences, Inc. S.M. Marcovina: None. S. Mckay: None. R.S. Weinstock: Board Member; Self; JDRF. Consultant; Self; Insulogic LLC. Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Jaeb Center for Health Research, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK61212)

Background: Subcutaneous (SC) insulin is non-physiologic, since normally insulin is secreted into the portal vein going directly to the liver. The OPTI-1 study was designed to determine whether delivery of Hepatic Directed Vesicles (HDV) admixed with Lispro (HDV-L) decreases hypoglycemia in well controlled adults with type 1 diabetes (T1D) using multiple daily insulin injections with an unblinded Dexcom G6 (CGM). Methods: OPTI-1 was a 6-month (mo) open label study of prandial insulin (lispro, 3 mo, then HDV-L, 3 mo) with basal insulin degludec and unblinded CGM in T1D with baseline A1C 6.5-8.5%. Target fasting blood glucose was 80-100 mg/dL. At 3 mo subjects were randomized to -10% or -40% basal dose to encourage titration with HDV-L. Physicians titrated basal insulin doses weekly. A hypoglycemic event was defined as ≥15 min of CGM ≤54 mg/dL. Results: In 61 participants, the mean baseline A1C was 7.3%. A1C was 6.9% after 3 mo lispro optimization, and 7.0% after 3 mo HDV-L optimization. At study end, the degludec dosage was similar, while HDV-L dose increased 0.03 u/kg/day (+13%, p=0.023) compared to optimal lispro. At baseline there were 1.11 hypoglycemic events per week (EPW) (1.04 Daytime “DT” and 1.39 Nighttime “NT” EPW), which decreased by 11% to 0.99 EPW (0.93 DT and 1.10 NT EPW) at 3 mo. The switch to HDV-L from lispro at 3 mo resulted in a further 20% decrease in events to 0.80 EPW (p=0.18; 0.86 DT, and 0.75 NT EPW p=0.08) by end of study. Discussion: The use of prandial HDV-L vs. lispro insulin reduced hypoglycemia, especially nocturnal hypoglycemia, without a rise in A1C. This reduction in hypoglycemia is consistent with the putative benefit of targeting insulin to the liver by inducing glycogen storage postprandially, which may lead to a decrease in hypoglycemia especially at night. We conclude that hepatic-directed insulin delivery in adults with T1D helps to restore hepatic physiology and reduce hypoglycemia. Disclosure B.W. Bode: Advisory Panel; Self; Medtronic, Novo Nordisk A/S. Consultant; Self; Eli Lilly and Company, Medtronic, Novo Nordisk A/S. Research Support; Self; Abbott, Advance, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, National Institutes of Health, Nova Biomedical, Novo Nordisk A/S, Provention Bio, Inc., Sanofi, Senseonics. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, Novo Nordisk A/S, Sanofi, Senseonics. Stock/Shareholder; Self; Aseko. R.S. Weinstock: Board Member; Self; JDRF. Consultant; Self; Insulogic LLC. Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Jaeb Center for Health Research, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. S.K. Garg: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Diagnostics France. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. D.C. Klonoff: Consultant; Self; Abbott, Ascensia Diabetes Care, Dexcom, Inc., EOFlow, Fractyl Laboratories, Inc., Know Labs, LifeCare, Inc., Novo Nordisk Inc., Roche Diabetes Care. K.K. Singh: None. D.B. Muchmore: Consultant; Self; Capillary Biomedical, Inc., Diasome Pharmaceuticals, Inc., Zucara Therapeutics Inc. Stock/Shareholder; Self; Capillary Biomedical, Inc., Diasome Pharmaceuticals, Inc. M.S. Penn: Board Member; Self; Diasome Pharmaceuticals, Inc. Consultant; Self; Diasome Pharmaceuticals, Inc., Quest Diagnostics. W. Geho: Other Relationship; Self; Diasome Pharmaceuticals, Inc. C.E. El Sanadi: None.

Background: Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) participants have youth-onset type 2 diabetes (T2D) and often poor glycemic control. The role of medication adherence is unknown. Aims: To assess oral diabetes medication adherence in the TODAY2 cohort; To assess participant factors related to adherence. Methods: Participants provided data at TODAY2 visits and at 3 monthly unannounced phone pill counts. Those taking ≥80% of pills were classified “high adherent,” those taking Results: Of 381 individuals, 224 were either taking oral meds (n=190) or taking none though meds were recommended (n=34) [mean age 25 yrs, 67% female, 18% white, 34% black, 39% Hispanic, 84% Conclusion: In emerging adults with youth-onset T2D, poor adherence to oral diabetes meds was common, and significantly more likely in those without health insurance and in non-Hispanic blacks. Interventions are needed to improve adherence and outcomes. Disclosure P.M. Trief: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. S. Kalichman: None. D. Wang: None. K. Drews: None. B. Anderson: None. R.S. Weinstock: Board Member; Self; JDRF. Consultant; Self; Insulogic LLC. Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Jaeb Center for Health Research, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. Funding National Institutes of Health (R01DK110456)

Insulin pump therapy is increasing in T2D but real-world use has not been well studied. This report describes insulin delivery and glucose data from adults with T2D using a tubeless insulin pump (Omnipod® Insulin Management System, Acton, MA) with an integrated blood glucose (BG) meter (Abbott Diabetes Care Inc., Alameda, CA) and data management system (DMS; Glooko, Mountain View, CA). Pump system usage data uploaded to the DMS from Feb.-Aug. 2019 were linked to a database of self-reported demographic data and de-identified. Insulin and BG data from ≥3 mo of system use per user were analyzed. Adults (n=1,202) were aged (mean±SD) 58±11 yr: 47% female, 28% aged ≥65 yr. Total daily insulin was 61±29 units/d delivered as 60±16% basal. Percentage of total daily insulin from basal delivery was ≥50% for 73% of users, and ≥70% for 26%. Only 4.5% and 0.6% of users received ≥90% or These real-world data demonstrate positive self-management behaviors among a large cohort of adults with T2D using a tubeless insulin pump. Both basal and bolus insulin delivery were used by ≥95%, with 81% bolusing at least twice per day, and 22% using EB/TBR features. These results support the tubeless pump as a practicable option for those with T2D requiring insulin therapy. Disclosure I.B. Hirsch: Consultant; Self; Abbott, Bigfoot Biomedical, Roche Diabetes Care. Research Support; Self; Medtronic, Omnipod. R.S. Weinstock: Board Member; Self; JDRF. Consultant; Self; Insulogic LLC. Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Jaeb Center for Health Research, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. L.M. Huyett: Employee; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. A. Chang: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation

Objective: To describe perceived burdens and benefits of continuous glucose monitor (CGM) use in CGM non-users vs. users with type 1 diabetes across the lifespan. Research Design and Methods: The Burdens of CGM (BurCGM) and Benefit of CGM (BenCGM) questionnaires were completed at clinic visits from Feb 2019 to Nov 2019. Mean scores were calculated (scale 1-5; higher score reflects greater perceived burdens and benefits). Data collected from medical records included demographic information, CGM and insulin pump use, and HbA1c within 3 months of the visit. Results: Participant characteristics (n=1143) and the 3 most common perceived CGM burdens (in non-CGM users) and benefits (in non-CGM users and CGM users) are shown in the Table. Individuals using real time (RT) and non-RT CGM described more benefits (mean scores 34.9 and 34.0) when compared to those who never used CGM (mean score 30.2) (p9.0%. Conclusions: Cost is a barrier to CGM use, particularly in adults. In non-CGM users (vs. users), CGM was perceived as having less benefit and to be associated with pain and concern that readings cannot be trusted. Advocacy (for lower cost) and education are needed to address these barriers. Disclosure V. Divan: None. M. Greenfield: None. C.P. Morley: None. R.S. Weinstock: Board Member; Self; JDRF. Consultant; Self; Insulogic LLC. Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Jaeb Center for Health Research, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. Funding Type 1 Diabetes Exchange QI Learning Collaborative

Many studies have demonstrated the clinical benefit of continuous glucose monitoring (CGM) in type 1 diabetes (T1D). Although favorable insurance policy changes have gradually increased the access of CGM nationally, widespread uptake has been slow. The T1DX-QI is a national type 1 diabetes learning collaborative coordinated by the T1D Exchange in Boston, MA. This work describes how 10 diabetes centers in the T1DX-QI used QI principles including the Plan - Do - Study - Act (PDSA) cycles to test and expand different interventions to increase CGM use in their respective centers. Successful efforts include the redesign of relevant workflows, assessing and removing barriers to adoption, developing CGM patient education classes, and advocating for state Medicaid coverage of CGM. The centers piloted these changes in 12 - 26 year olds with T1D. The coordinating center used statistical process control charts to evaluate the effectiveness of the interventions (Figure 1). Eight of 10 participating centers improved CGM use significantly. There was a 12% improvement from over 20 months across the entire cohort of centers (range 7-34%). This demonstrates that by using QI principles to test interventions and cross-learning, the T1D community can increase use of CGM devices. Figure 1. Disclosure O. Ebekozien: None. N. Rioles: None. D. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation. K. Gallagher: None. J.M. Lee: Advisory Panel; Self; Goodrx. Consultant; Self; T1D Exchange. Research Support; Self; Lenovo. R. McDonough: None. K. Obrynba: None. P. Prahalad: None. S. Thomas: None. R.S. Weinstock: Board Member; Self; JDRF. Consultant; Self; Insulogic LLC. Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Jaeb Center for Health Research, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. S. Corathers: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Aims Little is known about cognition in older adults with type 1 diabetes. The aim of this study was to identify correlates of clinically significant cognitive impairment. Methods Neuropsychological, diabetes-related and glycemic (HbA1c, Continuous Glucose Monitoring; CGM) data were collected from 201 older adults (≥60 years) with longstanding type 1 diabetes. Results Clinically significant cognitive impairment (≥2 cognitive tests ≥1.5 SD below normative data) occurred in 48% of the sample. After controlling for age, gender, education and diabetes duration, we found that hypoglycemia unawareness, recent severe hypoglycemic events, any microvascular complication, higher HbA1c and CGM average nocturnal glucose were all associated with increased odds of clinically significant cognitive impairment (ORs = 1.01–2.61), while CGM nocturnal % time below 60 mg/dL was associated with a decreased odds of cognitive impairment (OR = 0.94). Diabetes duration, diagnosis age, daytime CGM, and lifetime severe hypoglycemic events were not related to cognitive impairment status. Conclusions Clinically significant cognitive impairment was common in older adults with type 1 diabetes. Diabetes-related correlates of cognitive impairment were identified, including hypoglycemia unawareness, recent severe hypoglycemic events, and CGM variables. Longitudinal research is needed to determine if these variables predict cognitive decline and if their modification alters outcomes.

The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Adults with type 1 diabetes (N = 27) or type 2 diabetes using insulin (N = 7) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail. CGM was initiated with a certified diabetes care and education specialist providing instruction via videoconference or phone. The primary outcome was days per week of CGM use during the last 4 weeks. Hemoglobin A1c (HbA1c) was measured at baseline and 12 weeks. Participant self-reported outcome measures were also evaluated. All 34 participants (mean age, 46 ± 18 years; 53% female, 85% white) were using CGM at 12 weeks, with 94% using CGM at least 6 days per week during weeks 9 to 12. Mean HbA1c decreased from 8.3 ± 1.6 at baseline to 7.2 ± 1.3 at 12 weeks (P

PURPOSE: Assess systemic vascular endothelial growth factor-A (VEGF) levels after treatment with intravitreous aflibercept, bevacizumab or ranibizumab. DESIGN: Comparative-effectiveness trial with participants randomly assigned to 2-mg aflibercept, 1.25-mg bevacizumab, or 0.3-mg ranibizumab following a retreatment algorithm. PARTICIPANTS: Participants with available plasma samples (N=436) METHODS: Plasma samples were collected before injections at baseline, 4-week, 52-week and 104-week visits. In a pre-planned secondary analysis, systemic free-VEGF levels from an ELISA immunoassay were compared across anti-VEGF agents and correlated with systemic side effects. MAIN OUTCOME MEASURES: Changes in the natural log (ln) of plasma VEGF levels. RESULTS: Baseline free-VEGF levels were similar across all 3 groups. At 4 weeks, mean ln(VEGF) changes were −0.30±0.61, −0.31±0.54, −0.02±0.44 pg/ml for the aflibercept, bevacizumab, and ranibizumab groups, respectively. The adjusted differences between treatment groups (adjusted CI; P-value) were −0.01 (−0.12, +0.10; P=0.89), −0.31 (−0.44, −0.18; P

To assess prevalence of, and factors associated with, medication adherence of young adults with youth-onset type 2 diabetes.Oral hypoglycaemia agent (OHA) adherence was measured with unannounced telephone pill counts, insulin adherence was self-reported. Those taking ≥ 80% of pills/insulin were classified "high-adherent,"80% of pills/insulin "low-adherent." Analyses included unadjusted, and adjusted linear and logistic regressions assessing associations of participant factors with adherence.For people taking OHAs (N = 212, mean age 26 yrs, 67% women, 18% non-Hispanic White, 35% non-Hispanic Black, 41% Hispanic), 69.8% were low-adherent. HbA1c was lower in the high-adherent group (9.2%/77 mmol/mol vs. 10.0%/86 mmol/mol, p 0.04). More non-Hispanic Blacks were low-adherent (85.7%) than Hispanics (60.2%) and non-Hispanic whites (55.3%, p 0.002); 91.4% of participants without healthcare coverage were low-adherent vs. 65.5% of those with coverage (p 0.004). After adjustment, gender (p = 0.024), race/ethnicity (p 0.001) and healthcare coverage (p = 0.001) remained related to OHA adherence. For insulin (N = 192), 37% were low-adherent. HbA1c was associated with insulin adherence (low = 11.2%/99 mmol/mol vs. high = 10.0%/86 mmol/mol, p 0.001) with and without adjustment.Young adults with youth-onset type 2 diabetes, especially females, non-Hispanic Blacks and those without healthcare coverage, commonly had low-OHA adherence. Glycaemic control was also poor. Interventions to improve medication adherence are needed for this vulnerable group.

The data presented by Dunne et al. (1,2) are clear and add to the growing literature describing hurdles faced by women in health care and academia. Gender disparities are evident in diabetes-related professions, and in the structure of diabetes associations and governmental research funding sources, these disparities are unfortunately no surprise. As pointed out by the authors, as well as by Sandoval et al. (3,4), the reasons for this gender gap are multiple, spanning social, institutional, cultural, governmental, and organizational domains. These complex issues demand deliberate attention and actions at all organizational and governmental levels. We recognize our collective history and have been striving toward rectifying these disparities. The American Diabetes Association (ADA) stands for equal treatment of all people, irrespective of gender, race, and ethnicity. One of our strategic priorities is helping people thrive, which can only be fully realized when we embrace diversity, equity, and inclusion (DEI). This needs to be firmly rooted in our organizational structure, volunteer composition, and community conversations. In recent years, the ADA has taken steps to improve processes, policies, practice, and culture to reduce inequalities. This evolution starts within. Here we describe the steps ADA has taken …

Background: Hypoglycemia and hypoglycemia unawareness are common in long-standing type 1 diabetes (T1D). This pilot study examined the real-world use of a smartphone application (app), which receives meter readings and logs hypoglycemic symptoms, causes, and treatments to reduce hypoglycemia. Methods: Adults with T1D and recent hypoglycemia synchronized their glucose meter to their smartphone and used the Joslin HypoMap™ app powered by Glooko to track hypoglycemic events. At baseline, and after 6 and 12 weeks of using the app, a blinded continuous glucose monitor (CGM; Dexcom G4) was used for 2 weeks and surveys administered. Results: Participants (n = 22) at baseline had mean (SD) age 43 (14) years, duration of diabetes 26 (13) years, A1c 8.0% (0.87) and 21/22 had reduced hypoglycemia awareness per Clarke Hypoglycemia Unawareness survey scores; 13 (59%) were “CGM completers” (CGM data available at baseline and follow-up). Most noncompletion related to time required/difficulties using the mobile app. After 6 weeks, 8/13 completers (62% of CGM completers, 36% of total participants) had reduced daytime minutes with glucose Conclusions: Use of this phone app has the potential to help reduce daytime hypoglycemia in a subset of T1D adults with reduce hypoglycemia awareness; larger studies are needed.

Context Standard treatment of hypoglycemia is oral carbohydrate, but it often results in hyperglycemia and entails extra caloric intake. Objective To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design Randomized crossover trial (two 3-week periods). Setting Five U.S. diabetes clinics. Patients Twenty adults with T1D using an insulin pump and continuous glucose monitor (CGM) and experiencing frequent mild hypoglycemia. Intervention Nonaqueous mini-dose glucagon (MDG) (150 µg) to treat nonsevere hypoglycemia. Main outcome measures Successful treatment was defined as blood glucose (BG) ≥50 mg/dL 15 minutes and ≥70 mg/dL 30 minutes after intervention, on the study meter. Two authors, blinded to treatment arm, independently judged each event as a clinical success or failure. Results Sixteen participants (mean age 39 years, 75% female, mean diabetes duration 23 years, mean hemoglobin A1c 7.2%) had 118 analyzable events with initial BG of 50 to 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the MDG period and 53 (95%) of 56 events during the glucose tablets (TABS) period (adjusted P = 0.99). Clinical assessments of success for these events were 97% and 96%, respectively. CGM-measured time in range did not differ between treatment groups during the 2 hours after events, but TABS resulted in higher maximum glucose (116 vs 102 mg/dL; P = 0.01) over the first hour. Conclusions Low-dose glucagon can successfully treat mild hypoglycemia and may be a useful alternative to treatment with oral carbohydrate when trying to avoid unnecessary caloric intake.

Aims To use a three-phase process to develop and validate new self-report measures of diabetes-specific health-related quality of life (HRQOL) for adults with type 1 diabetes. We report on four versions of the Type 1 Diabetes and Life (T1DAL) measure for people age 18–25, 26–45, 46–60, and over 60 years. Methods We first conducted qualitative interviews to guide measure creation, then piloted the draft measures. We evaluated psychometric properties at six T1D Exchange Clinic Network sites via completion of T1DAL and validated measures of related constructs. Participants completed the T1DAL again in 4–6 weeks. We used psychometric data to reduce each measure to 23–27 items in length. Finally, we obtained participant feedback on the final measures. Results The T1DAL-Adult measures demonstrated good internal consistency (α = 0.85–0.88) and test–retest reliability (r = 0.77–0.87). Significant correlations with measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, self-management, and glycemic control demonstrated validity. Factor analyses yielded 4–5 subscales per measure. Participants were satisfied with the final measures and reported they took 5–10 min to complete. Conclusions The strong psychometric properties of the newly developed self-report T1DAL measures for adults with type 1 diabetes make them appropriate for use in clinical research and care.

Aims Compare characteristics, therapies and clinical outcomes in older adults with type 1 diabetes in the United States T1D Exchange (T1DX) and German/Austrian Diabetes Patienten Verlaufsdokumentation (DPV) registries. Methods Cross-sectional study of adults ≥60years old with type 1 diabetes seen in 2011–2012 in the T1DX ( n =1283) and DPV ( n =2014) registries. Wilcoxon rank-sum test was used for continuous variables and chi-square test for categorical variables. Adjusted analyses used generalized linear models. Results Individuals in both registries were similar in body mass index (mean 27kg/m 2 ), percent with obesity (25%) and gender (48% male). In T1DX there was longer diabetes duration (32.3 vs. 28.8years), greater use of antihypertensive medications (including ACE-I and ARBs; 85% vs. 62%), statins (68% vs. 40%), aspirin (77% vs. 21%), insulin pumps (58% vs. 18%), and less smoking (7% vs. 10%); lower adjusted mean LDL-cholesterol (84 vs. 109mg/dL), and lower adjusted mean systolic and diastolic blood pressures (128 vs. 136 and 68 vs. 74mmHg); fewer myocardial infarctions (6% vs. 9% [99% CI of difference, 1% to 5%]), strokes (2% vs. 8% [3% to 7%]), microvascular complications including microalbuminuria (17% vs. 44% [22% to 32%]) but increased depression (16.1% vs. 8.7%). Adjusted mean HbA1c levels were similar (7.5%, 58mmol/mol). Conclusions Differences between the registries included greater use of antihypertensives, statins and insulin pumps, and fewer chronic complications in the T1DX. Further research is needed to better understand the role of intensive therapy in improving outcomes in older adults with type 1 diabetes.