Diabetes technology & therapeutics
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Diabetes Technol. Ther. · Dec 2005
Randomized Controlled Trial Multicenter Study Comparative StudyGlycated hemoglobin assessment in clinical practice: comparison of the A1cNow point-of-care device with central laboratory testing (GOAL A1C Study).
The Glycemic Optimization with Algorithms and Labs At Po1nt of Care (GOAL A1C) Study assessed the effect of titration monitoring strategies and methods of A1C testing on glycemic control in patients with type 2 diabetes failing oral therapy and beginning basal insulin glargine. The availability of both point-of-care (POC) and central laboratory A1C values provided an opportunity to evaluate correlation and statistical agreement between these methods of testing. This analysis forms the basis of the current report. ⋯ POC testing of A1C in predominantly primary care settings using the A1cNow device was correlated with central laboratory results. The correlation was less than expected based on each method's reproducibility data. Although there was agreement between the average POC A1C values and the corresponding central laboratory values, the dispersion of individual POC A1C values was large. Thus, we conclude that these two methods of A1C testing should not be used interchangeably.
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Diabetes Technol. Ther. · Apr 2004
Randomized Controlled Trial Clinical TrialAlarms based on real-time sensor glucose values alert patients to hypo- and hyperglycemia: the guardian continuous monitoring system.
The purposes of this study were to demonstrate the accuracy and effectiveness of the Guardian Continuous Monitoring System (Medtronic MiniMed, Northridge, California) and to demonstrate that the application of real-time alarms to continuous monitoring alerts users to hypo and hyperglycemia and reduces excursions in people with diabetes. A total of 71 subjects with type 1 diabetes, mean hemoglobin A1c of 7.6 +/- 1.1%, age 44.0 +/- 11.4 years, and duration of diabetes 23.6 +/- 10.6 years were enrolled in this two-period, randomized, multicenter study. Subjects were randomized into either an Alert group or a Control group. ⋯ A marginally significant increase in the frequency of hyperglycemic excursions (P = 0.07) between Period 1 and Period 2 was accompanied by a decrease of 9.6 min in the duration of hyperglycemic excursions in the Alert group. Glucose measurements differ between blood samples taken from the finger and interstitial fluid, especially when levels are changing rapidly; however, these results demonstrate that the Guardian is reasonably accurate while performing continuous glucose monitoring. The subjects' responses to hypoglycemia alerts resulted in a significant reduction in the duration of hypoglycemic excursions; however, overtreating hypoglycemia may have resulted in a marginally significant increase in the frequency of hyperglycemic excursions.
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Diabetes Technol. Ther. · Apr 2004
Randomized Controlled Trial Clinical TrialImpact of particle size and aerosolization time on the metabolic effect of an inhaled insulin aerosol.
The effects were compared of varying aerosol particle size and aerosolization time within each breath on the metabolic effect elicited by inhalation of a liquid insulin aerosol in comparison with that after subcutaneous injection (s.c.) of regular insulin. In this single-center, open-label euglycemic glucose clamp study, 13 healthy non-smoking subjects received five administrations of insulin in randomized order on separate study days, once by s.c. (0.15 U/kg of regular insulin) and four times by inhalation. Subjects inhaled 1.5 U/kg of liquid insulin aerosol administered by the Aerodose Insulin Inhaler (Aerogen Inc., Mountain View, CA) configured to deliver two aerosol particle sizes--fine [F, 4.4 +/- 0.3 microm (mean +/- SD)] or very fine (VF, 3.5 +/- 0.2 microm)--and two aerosolization times (aerosol released for the first 2 or 4 s after the start of each 5-s inhalation). ⋯ No drug- or device-related adverse events were observed. This study shows that aerosolization time, but not particle size, in the ranges studied, had an impact on the metabolic effect elicited by inhaled insulin, allowing rational selection of delivery parameters for further clinical testing. Based on the observed biopotency and the rapid onset of action, inhalation of a liquid insulin aerosol generated by the Aerodose Insulin Inhaler shows promise for covering prandial insulin requirements.