ObjectiveThe goal of this study was to describe medication usage patterns in patients with type 2 diabetes mellitus (T2DM) initiating treatment with non-insulin antidiabetic drugs (NIADs), basal insulin, or prandial/mixed insulin using real-world data.Research design and methodsA retrospective analysis using the Truven Health MarketScan Research Databases was conducted to identify adults (≥18 years) with T2DM from 2006 to 2012. Patients were categorized into four cohorts based on diabetes treatment. Cohort 1 (n=597 664) consisted of newly diagnosed patients who did not receive any treatment, cohort 2 (n=342 511) included NIAD initiators, cohort 3 (n=99 578) included basal insulin initiators, and cohort 4 (n=62 876) included prandial/mixed insulin initiators. Patients transitioned out of a cohort once they met the criteria for the next one.ResultsPatients in cohort 2 were younger (56.2 years, SD±12.1) than patients in cohorts 1, 3, and 4 (58 years, SD±0.75). Metformin was the most commonly prescribed drug in cohort 2 patients. Basal insulin usage decreased from 71% in year 1 to 47% in year 4, in cohort 3 patients. Approximately one-third of these patients switched to prandial/mixed insulin each year. In cohort 4, the usage of prandial/mixed insulin decreased to 61% by year 4. Use of basal insulin and NIAD remained common in this group. Mean glycosylated hemoglobin (HbA1c) values decreased by ∼1% for each of the treatment cohorts following treatment initiation and remained stable during follow-up. All-cause and diabetes-related medical costs were highest for patients in cohorts 3 and 4.ConclusionsOverall, our findings demonstrate that treatment intensification was low in all study cohorts despite elevated HbA1c levels during preindex and follow-up period.

Objective: Accuracy is recognized as an important attribute of continuous glucose monitors (CGMs). The objective of this research was to understand if improvements in CGM accuracy impact clinical outcomes in patients with T1DM or T2DM. Research Design and Methods: A review of literature published from January 1999 to June 2017 was conducted using Medline. Articles were included if they reported desired outcome measures of clinical efficacy (HbA1c reduction, time-in-range [TIR], hypoglycemia detection or reduction) regardless of patient diabetes type. Simple linear and multiple regressions were utilized to evaluate the relationship between mean absolute relative difference (MARD) and measures of efficacy. Results: The literature search yielded 574 results from which 20 articles met the inclusion criteria. MARD for commercialized CGM devices improved, on average, 0.75% per year (R2=0.87, p<0.0001). There was no significant correlation between HbA1c reduction and MARD (coefficient=0.464, R2=0, p=0.8857). A significant relationship was observed between MARD and the detection of hypoglycemic events (coefficient= -0.33, R2=0.63, p<0.0001). Insufficient data was available to assess the correlation between accuracy and TIR or hypoglycemia reduction. Conclusion: CGM accuracy correlates with an increased detection of hypoglycemic events, but not with HbA1c reduction. Disclosure C.J. Koziel: None. D. Bialonczyk: Employee; Self; Becton, Dickinson and Company. D. Morel: Employee; Self; Becton, Dickinson and Company. J. Petisce: None. D. Saliu: Employee; Self; Becton, Dickinson and Company.

Objective: To assess usability, 24-hour glycemic profiles, and safety of an investigational basal/bolus IDD in people with T2D transitioning from MDI. Research Design and Methods: This single-center, open-label, two-period pilot study enrolled people with T2D and HbA1c 7-11%. Subjects continued their usual MDI therapy during a 2-3 -day in-clinic MDI period and then were switched to the IDD for a 6-day in-clinic IDD period, without changing insulin dose. Subjects wore blinded CGM throughout each in-clinic period. Results: Twenty-one people (mean±SD age 57±8 years; HbA1c 8.2±0.9%) using U-100 insulin lispro (n=11) or U-100 regular human insulin RHI (n=10) were enrolled. Glycemic measures improved from the MDI to the IDD period, including FBG: 141.2 ± 38.3 mg/dl vs. 121.2 ± 35.0 mg/dl (P=0.002), respectively; 24-hour mean glucose: 137.0 ± 20.5 mg/dl vs.125.0 ± 16.5 mg/dl (P=0.004), and time-in-range (70-180 mg/dL): 81.0 ± 14.4% vs. 87.5 ± 10.6% (P=0.008). There were no significant differences between MDI and IDD for time in hypoglycemia (<70 mg/dL), CV%, nor mean of daily differences (MODD). Mean amplitude of glycemic excursions (MAGE) was significantly lower with IDD (P=0.011). There were no serious AEs. There were no significant differences between insulin lispro and RHI for any glycemic measures, within either phase. *Disclaimer: RHI is not approved for use in pumps. IDD not available for sale. Conclusions: Results of this pilot study suggest that the IDD, used with insulin lispro or RHI, is as safe and effective for adults previously prescribed MDI therapy, without requiring dose change, in the short term. Administering either insulin lispro or RHI in the IDD led to similar glycemic responses and outcomes based on 24-hour glycemic profiles in people with T2D. To our knowledge, this is the first study to evaluate RHI in people with T2D using CGM for 24-hour glycemic profiles. Additional trials are warranted to further evaluate this novel IDD in larger populations. Disclosure R. Aronson: Research Support; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Senseonics. E.T. Mahoney: Employee; Self; Becton, Dickinson and Company. D. Saliu: Employee; Spouse/Partner; Allergan. Employee; Self; Becton, Dickinson and Company. L. Bergquist: Employee; Self; Becton, Dickinson and Company. L. Hirsch: Employee; Self; Becton, Dickinson and Company. Stock/Shareholder; Self; Merck & Co., Inc.

Background: This study undertook to assess usability, 24-h glycemic profiles, and safety of an investigational basal/bolus insulin delivery device (IDD) providing rapid-acting or regular human insulin (RHI) for people with type 2 diabetes (T2D) transitioning from multiple daily insulin injections (MDIs). Methods: This prospective, single-center, open-label two-period study enrolled adults with T2D and glycated hemoglobin (HbA1c) 7%-11% (53-97 mmol/M). Participants continued the usual MDI therapy during a 2-to 3-day in-clinic MDI period and then within 7 days were switched to the IDD, using current insulin dose, for a 6-day in-clinic IDD period, with blinded continuous glucose monitoring throughout the in-clinic periods. Results: We enrolled 21 participants (meanstandard deviation age 57-8 years; HbA1c 8.2%-0.9% [66-9.8 mmol/M]) using U-100 insulin lispro (n = 11) or who switched to U-100 RHI (n = 10). Glycemic measures improved from the MDI to IDD period, including fasting blood glucose (BG), 141.2-38.3 mg/dL (7.8-2.1 mmol/L) versus 121.2-35.0 mg/dL (6.7-1.9 mmol/L; P = 0.002), respectively; 24-h mean BG, 137.0-20.5 mg/dL (7.6-1.1 mmol/L) versus 125.0-16.5 mg/dL (6.9-0.9 mmol/L; P = 0.004); and time in range (at 70-180 mg/dL; 3.9-10 mmol/L), 81.0%-14.4% versus 87.5%-10.6% (P = 0.008). No significant differences between MDIs and IDD use were recorded for time <70 mg/dL (1.6%-2.7% vs. 3.1%-2.7%, P = 0.08), CV%, or mean of daily differences. Mean amplitude of glycemic excursions was significantly lower with the IDD (P = 0.011). There were no significant differences between insulin lispro and RHI for any glycemic measure. No serious adverse events were recorded. Conclusions: In the context of this exploratory study, the IDD was safe and effective to administer insulin lispro and RHI for adults with T2D.