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Time spent in glycemic target range (time in range [TIR]; plasma glucose 70-180 mg/dL [3.9-10.0 mmol/L]) as a surrogate endpoint for long-term diabetes-related outcomes requires validation. This post hoc analysis investigated the association between TIR, derived from 8-point glucose profiles (derived TIR [dTIR]) at 12 months, and time to cardiovascular or severe hypoglycemic episodes in people with type 2 diabetes in the DEVOTE trial. At 12 months, dTIR was significantly negatively associated with time to first major adverse cardiovascular event ( P  = 0.0087), severe hypoglycemic episode ( P  < 0.0001), or microvascular event ( P  = 0.024). A nonsignificant trend was seen toward association between 12-month hemoglobin A1c (HbA1c) and these outcomes, but this was no longer seen after addition of dTIR to the model. The results support targeting TIR >70% and suggest dTIR could be used in addition to, or in some instances in place of, HbA1c as a clinical biomarker. Trial registration details: ClinicalTrials.gov, NCT01959529.

Background: Despite increased use of continuous glucose monitoring (CGM) systems, studies to quantify patterns of CGM use are limited. In December 2018, a policy change by a commercial insurer expanded coverage of CGM through the pharmacy benefit, creating an opportunity to evaluate the impact of this change on CGM utilization. Research Design and Methods: Pharmacy and medical claims from 2016 to 2020 were used to estimate the prevalence of CGM use among insulin users with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) before and after the policy change. Change in CGM use was assessed using an interrupted time series design. Results: At the beginning of the study period, 18.8% of T1DM patients and 1.2% of T2DM patients used CGM. Use rose to 30.5% and 6.6% in the quarter before the policy change. The policy resulted in an immediate 9.5% ( P  < 0.0001) and 2.8% ( P  < 0.0001) change in use and increased the rate of quarterly change by 0.5% ( P  = 0.002) and 0.8% ( P  < 0.0001). At the end of the study period, 58.2% and 14.9% of T1DM and T2DM patients used CGM. Conclusion: CGM use significantly increased after addition to the pharmacy benefit. Rate of change in CGM use was lower in T1DM compared to the T2DM population, but overall use remained higher among patients with T1DM. Increased CGM use in the population studied aligns with those whose clinical guidelines suggest would most likely benefit. Additional work is needed to evaluate the impact of this benefit change on health care spending and outcomes.

Background: Diabetes-related distress is common among persons affected by diabetes and is associated with suboptimal glycemic control and complications, thus constituting a relevant patient-report outcome (PRO). Improving glycemic control may reduce diabetes distress and improve treatment satisfaction. This post hoc analysis evaluated PRO data for a pooled cohort of adults with type 1 diabetes (T1D) receiving sotagliflozin as adjunct to optimized insulin in the inTandem1 and inTandem2 studies. Methods: Clinically meaningful changes in the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and the two-item Diabetes Distress Scale (DDS2) total and individual scores were examined in the pooled data from the first 24 weeks of the studies. Results: In the cohort of patients with a baseline DTSQs total score ≤32 (∼76% of entire cohort), nearly twice as many patients treated with sotagliflozin 200 (45.9%) or 400 mg (42.3%) experienced a >3-point improvement from baseline versus those treated with placebo (24%). Treatment with sotagliflozin led to statistically significant ( P  < 0.05) improvements across all DTSQs items. Approximately 42% of all patients were considered to have a high risk of diabetes distress (total DDS2 score ≥6) at baseline following insulin optimization. More patients shifted from high to low risk with sotagliflozin compared with placebo (∼40% vs. 23%; P  ≤ 0.0002). The baseline-adjusted difference in DDS2 from placebo was significantly ( P  < 0.001) reduced by -0.5 and -0.6 for sotagliflozin 200 and 400 mg, respectively. Conclusions: Patients with T1D treated with sotagliflozin in addition to optimized insulin therapy reported meaningful improvements in treatment satisfaction and diabetes distress. NCT02384941 and NCT02421510.

Introduction: During the coronavirus disease 2019 (COVID-19) outbreak, novel approaches to diabetes care have been employed. Care in both the inpatient and outpatient setting has transformed considerably. Driven by the need to reduce the use of personal protective equipment and exposure for patients and providers alike, we transitioned inpatient diabetes management services to largely "virtual" or remotely provided care at our hospital. Methods: Implementation of a diabetes co-management service under the direction of the University of North Carolina division of endocrinology was initiated in July 2019. In response to the COVID-19 pandemic, the diabetes service was largely transitioned to a virtual care model in March 2020. Automatic consults for COVID-19 patients were implemented. Glycemic outcomes from before and after transition to virtual care were evaluated. Results: Data over a 15-week period suggest that using virtual care for diabetes management in the hospital is feasible and can provide similar outcomes to traditional face-to-face care. Conclusion: Automatic consults for COVID-19 patients ensure that patients with serious illness receive specialized diabetes care. Transitioning to virtual care models does not limit the glycemic outcomes of inpatient diabetes care and should be employed to reduce patient and provider exposure in the setting of COVID-19. These findings may have implications for reducing nosocomial infection in less challenging times and might address shortage of health care providers, especially in the remote areas.

Background: Compared with multiple daily injections (MDI), sensor-augmented pump (SAP) insulin therapy may reduce glycemic variability and oxidative stress in type 1 diabetes in a glycosylated hemoglobin (A1C)-independent manner., Subjects and Methods: The STAR 3 study compared SAP with MDI therapy for 1 year. Week-long continuous glucose monitoring studies were conducted at baseline and 1 year for assessment of glycemic variability in both groups. Soluble CD40 ligand (CD40L), a biomarker of inflammation and thrombocyte function, was measured at baseline and 1 year. Subjects were classified according to treatment group and 1-year A1C levels (<6.5%, 6.5-6.9%, 7-7.9%, ≥8%). Glycemic parameters were compared between SAP and MDI subjects in each A1C cohort., Results: At 1 year, sensor glucose values at A1C levels ≥6.5% were similar in the SAP and MDI groups. However, sensor glucose SD and coefficient of variation (CV) values were lower at A1C levels <8% among SAP than among MDI subjects; the overall between-group difference was significant for both SD (P<0.01) and CV (P=0.01). The overall mean amplitude of glycemic excursion was similar in MDI and SAP groups (P=0.23). CD40L levels fell over the course of the study in both groups, but the between-group difference was not significant (P=0.18). CD40L concentrations were unrelated to A1C, change in A1C from baseline, or glycemic variability., Conclusions: At comparable A1C levels of <8%, SAP reduced glycemic variability as measured by SD and CV compared with MDI. SAP may provide beneficial reductions in the number and severity of glycemic excursions.

Background: Baseline characteristics from the adult cohort of a randomized controlled trial comparing sensor-augmented pump (SAP) and multiple daily injection (MDI) therapy were analyzed for significant relationships with -0.5% A1C change at 1 year of therapy without incidence of severe hypoglycemia (defined as A1C benefit)., Methods: Baseline characteristics were compared with A1C benefit. Statistically significant predictors were analyzed further to determine appropriate cutpoints of relative A1C benefit., Results: Baseline A1C ≥9.1%, age at randomization ≥36 years, and age at diabetes diagnosis of ≥17 years were associated with a greater SAP benefit relative to MDI than other cutpoints., Conclusions: People with type 1 diabetes who had a high A1C and who were older at diagnosis and older at randomization experienced the most benefit from SAP therapy.

1,5-Anhydroglucitol (1,5-AG), the 1-deoxy form of glucose, has been measured and used clinically in Japan for over a decade to monitor short-term glycemic control. Evaluation of glucose control otherwise requires measuring plasma glucose or glycated proteins whose levels reflect average glucose concentration over the half-life of the protein analyzed. Hemoglobin A1c measurements reflect blood glucose levels over that past 2-3 months, while fructosamine can be used to evaluate glycemic control over 10-14 days. In contrast, 1,5-AG levels in blood respond within 24 h as a result of glucose's competitive inhibition of 1,5-AG reabsorption in the kidney tubule. When glucose levels rise, even transiently, urinary loss of 1,5-AG occurs, and circulating levels fall. Because of changes in renal hemodynamics in normal pregnancies, 1,5-AG appears of limited usefulness in evaluation of gestational diabetes. However, the characteristics of 1,5-AG levels in patients with moderate to near-normal glycemic control suggest that it may be a valuable complement to frequent self-monitoring or continuous monitoring of plasma glucose to confirm stable glycemic control. Measurements performed daily or weekly in a given patient would suggest that overall glycemic control has been stable or improved if 1,5-AG levels are stable or increasing. If 1,5-AG levels fall, greater attention to glucose monitoring and both lifestyle and medical management could be prescribed to correct the glycemic excursions that would underlie such changes. The behavior of this analyte is different from all others used in the management of diabetes, creating potential opportunities for its use in clinical practice.