Background: Use of continuous glucose monitoring (CGM) systems can improve glycemic control, but widespread adoption of CGM utilization has been limited, in part because of real and perceived problems with accuracy and reliability. This study compared accuracy and performance metrics for a new-generation CGM system with those of a previous-generation device. Subjects and Methods: Subjects were enrolled in a 7-day, open-label, multicenter pivotal study. Sensor readings were compared with venous YSI measurements (blood glucose analyzer from YSI Inc., Yellow Springs, OH) every 15 min (-5 min) during in-clinic visits. The aggregate and individual sensor accuracy and reliability of a new CGM system, the Dexcom Ò (San Diego, CA) G4Ô PLATINUM (DG4P), were compared with those of the previous CGM system, the Dexcom SEVEN Ò PLUS (DSP). Results: Both study design and subject characteristics were similar. The aggregate mean absolute relative difference (MARD) for DG4P was 13% compared with 16% for DSP (P < 0.0001), and 82% of DG4P readings were within -20 mg/dL (for YSI £ 80 mg/dL) or 20% of YSI values (for YSI > 80 mg/dL) compared with 76% for DSP (P < 0.001). Ninety percent of the DG4P sensors had an individual MARD £ 20% compared with only 76% of DSP sensors (P = 0.015). Half of DG4P sensors had a MARD less than 12.5% compared with 14% for the DSP sensors (P = 0.028). The mean absolute difference for biochemical hypoglycemia (YSI < 70 mg/dL) for DG4P was 11 mg/dL compared with 16 mg/dL for DSP (P < 0.001). Conclusions: The performance of DG4P was significantly improved compared with that of DSP, which may increase routine clinical use of CGM and improve patient outcomes.

The Enlite sensor provided accurate data at different glucose concentrations and rates of change. Subjects found the sensor comfortable and easy to use.

Background Patients hospitalized with acute coronary syndrome (ACS) or heart failure (HF) are frequently readmitted. This is the first randomized controlled trial of a mobile health intervention that combines telemonitoring and education for inpatients with ACS or HF to prevent readmission. Objective This study aims to investigate the feasibility, efficacy, and cost-effectiveness of a smartphone app–based model of care (TeleClinical Care [TCC]) in patients discharged after ACS or HF admission. Methods In this pilot, 2-center randomized controlled trial, TCC was applied at discharge along with usual care to intervention arm participants. Control arm participants received usual care alone. Inclusion criteria were current admission with ACS or HF, ownership of a compatible smartphone, age ≥18 years, and provision of informed consent. The primary end point was the incidence of unplanned 30-day readmissions. Secondary end points included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness, and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure, and physical activity daily plus usual care. The devices automatically transmitted recordings to the patients’ smartphones and a central server. Thresholds for blood pressure, heart rate, and weight were determined by the treating cardiologists. Readings outside these thresholds were flagged to a monitoring team, who discussed salient abnormalities with the patients’ usual care providers (cardiologists, general practitioners, or HF outreach nurses), who were responsible for further management. The app also provided educational push notifications. Participants were followed up after 6 months. Results Overall, 164 inpatients were randomized (TCC: 81/164, 49.4%; control: 83/164, 50.6%; mean age 61.5, SD 12.3 years; 130/164, 79.3% men; 128/164, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P=.97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 in TCC vs 41 in the control arm; P=.02), including cardiac readmissions (11 in TCC vs 25 in the control arm; P=.03), and higher rates of cardiac rehabilitation completion (20/51, 39% vs 9/49, 18%; P=.03) and medication adherence (57/76, 75% vs 37/74, 50%; P=.002). The average usability rating for the app was 4.5/5. The intervention cost Aus $6028 (US $4342.26) per cardiac readmission saved. When modeled in a mainstream clinical setting, enrollment of 237 patients was projected to have the same expenditure compared with usual care, and enrollment of 500 patients was projected to save approximately Aus $100,000 (approximately US $70,000) annually. Conclusions TCC was feasible and safe for inpatients with either ACS or HF. The incidence of 30-day readmissions was similar; however, long-term benefits were demonstrated, including fewer readmissions over 6 months, improved medication adherence, and improved cardiac rehabilitation completion. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12618001547235; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375945

AimsMK‐1293 is an insulin glargine that has an amino acid sequence identical to that of Lantus, the originator insulin glargine. Two euglycaemic clamp studies, 1 in subjects with type 1 diabetes (T1D) and 1 in healthy subjects, were conducted to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK‐1293 and Lantus commercially procured in both the European Union (EU‐Lantus) and the USA (US‐Lantus).Materials and MethodsBoth studies were single‐dose, randomized, double‐blind, single‐centre, crossover studies with ≥7 days between dosing periods. A 2‐treatment, 4‐period replicate crossover study in T1D subjects (N = 76) compared the PK and PD of MK‐1293 to EU‐Lantus for 30 hours after dosing. A 3‐period crossover study in healthy subjects (N = 109) compared the PK and PD of MK‐1293, EU‐Lantus and US‐Lantus for 24 hours after dosing. In both studies, all subjects received single 0.4 units/kg subcutaneous doses of MK‐1293 or Lantus in all dosing periods. Pharmacokinetic assessment was based on LC‐MS/MS‐based measurement of the major insulin glargine metabolite (M1) and PD was characterized using the euglycaemic clamp platform.ResultsIn both studies, pre‐specified similarity criteria were met between MK‐1293 and Lantus for comparison of PK (AUC0‐24 and Cmax of M1) and PD (GIR‐AUC0‐24, GIR‐AUC0‐12, GIR‐AUC12‐24, and GIRmax) primary endpoints. All treatments were well tolerated.ConclusionBased on comparative assessment in both T1D and healthy subjects, it can be concluded that the PK and PD properties of MK‐1293 are highly similar to those of Lantus. (ClinicalTrials.gov: NCT02059174).

Mass casualty events (MCE) present health systems with a sudden demand on key services. The overall objective of this study was to describe the experience of the National Blood Service (NBS) following the largest UK MCE in recent times. Data was collated from the NBS database and directly from the hospitals involved. All data was collected immediately following the event and included: all blood components requested, issued and transfused in relation to the bombings, blood stock levels at the time and the injury profiles of the casualties transfused. The total NBS order from hospitals for the event was 1455 units of blood components. All requests were fulfilled, this included: 978 units of red cells (RC), 36 doses of platelets, 141 units of fresh frozen plasma (FFP) and 300 doses of cryoprecipitate. The amount of blood ordered was three times that initially used and the total number of RC transfused in treating all victims from admission to discharge was approximately 440 units. The greatest use of blood components was for those casualties who had sustained traumatic amputations amongst their injury profile. Published data with which to compare these results is lacking, although the RC use was similar to the initial mean individual usage described in previous military and civilian bombings. The overall implication for any blood service remains, there is now likely to be a far greater demand for plasma, platelets and cryoprecipitate in any future incidents involving victims suffering major haemorrhage.