The landmark JDRF continuous glucose monitoring randomized trials: a look back at the accumulated evidence.
ABSTRACT Despite improvements for management of type 1 diabetes (T1D), patients have difficulty achieving glycated hemoglobin (A1c) levels recommended by the Diabetes Control and Complications Trial (DCCT). Two multicenter randomized trials were conducted to evaluate benefit of using a continuous glucose monitor (CGM) with standard glucose monitoring for T1D management. The primary study evaluated benefits of CGM in 322 patients with A1c >7.0%. The secondary study evaluated 129 patients with A1c <7.0%. In the primary study, CGM resulted in improvements in A1c at 6 m in subjects >25 years, but not those <25. However, all subjects using CGM regularly showed benefit. Improved A1c did not come with increased severe hypoglycemia as seen in the DCCT, and benefit was sustained over 1 year. In the secondary study, CGM use helped subjects maintain target A1c levels with reduced exposure to biochemical hypoglycemia. The data collected allowed for other analyses of important factors in T1D management.
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ABSTRACT: BACKGROUND: Avoidance of hypoglycemia is a key consideration in treating young children with type 1 diabetes (T1DM). KEY OBJECTIVE: To evaluate hypoglycemia with insulin glargine vs. neutral protamine Hagedorn (NPH) insulin in young children, using continuous glucose monitoring (CGM). SUBJECTS: Children of 1 to <6 yr treated with once-daily glargine vs. once- or twice-daily NPH, with bolus insulin lispro/regular human insulin provided to all. METHODS: Twenty-four week, multicenter, randomized, open-label study. Primary endpoint was event rate of composite hypoglycemia [symptomatic hypoglycemia, low CGM excursions (<3.9 mmol/L) or low fingerstick blood glucose (FSBG; <3.9 mmol/L)]. Noninferiority of glargine vs. NPH was assessed for the primary endpoint. RESULTS: One hundred and twenty-five patients (mean age, 4.2 yr) were randomized to treatment (glargine, n = 61; NPH, n = 64). At baseline, mean HbA1c was 8.0 and 8.2% with glargine and NPH, respectively. Composite hypoglycemia episodes/100 patient-yr was 1.93 for glargine and 1.69 for NPH; glargine noninferiority was not met. Events/100 patient-yr of symptomatic hypoglycemia were 0.26 for glargine vs. 0.33 for NPH; low CGM excursions 0.75 vs. 0.72; and low FSBG 1.93 vs.1.68. There was a slight difference in between-group severe/nocturnal/severe nocturnal hypoglycemia and glycemic control. All glargine-treated patients received once-daily injections; on most study days NPH-treated patients received twice-daily injections. CONCLUSIONS: While glargine noninferiority was not achieved, in young children with T1DM, there was a slight difference in hypoglycemia outcomes and glycemic control between glargine and NPH. Once-daily glargine may therefore be a feasible alternative basal insulin in young populations, in whom administering injections can be problematic.Pediatric Diabetes 06/2013; · 2.08 Impact Factor
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ABSTRACT: In this work, we demonstrate in vitro detection of glucose by means of a lab-on-chip absorption spectroscopy approach. This optical method allows label-free and specific detection of glucose. We show glucose detection in aqueous glucose solutions in the clinically relevant concentration range with a silicon-based optofluidic chip. The sample interface is a spiral-shaped rib waveguide integrated on a silicon-on-insulator (SOI) photonic chip. This SOI chip is combined with micro-fluidics in poly(dimethylsiloxane) (PDMS). We apply aqueous glucose solutions with different concentrations and monitor continuously how the transmission spectrum changes due to glucose. Based on these measurements, we derived a linear regression model, to relate the measured glucose spectra with concentration with an error-of-fitting of only 1.14 mM. This paper explains the challenges involved and discusses the optimal configuration for on-chip evanescent absorption spectroscopy. In addition, the prospects for using this sensor for glucose detection in complex physiological media (e.g. serum) is briefly discussed.Biomedical Optics Express 05/2014; 5(5):1636-48. · 3.18 Impact Factor
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ABSTRACT: Advances in diabetes technologies allow patients to manage their diabetes with greater precision and flexibility. Many recent studies show that continuous glucose monitors (CGMs) can be used to tighten glycemic control safely and to ease certain burdens of diabetes self-management. The following summary reflects the most recent findings in CGM and provides an overall review of who would most benefit from CGM use. Benefits of CGM may vary based on age, type of diabetes, pregnancy, health, sleep, or heart rate. Accuracy and reliability are critical in current uses of CGM and especially for new and future systems that automate insulin partially (e.g., low glucose suspend) or entirely (e.g., 'fully closed-loop' artificial pancreas). Clinicians are simultaneously testing available products in new patient groups such as the critically ill and type 2 diabetes patients not using mealtime insulin. In a widening set of circumstances, use of CGM has been shown to promote safer and more effective glycemic control than self-monitoring of blood glucose. Imperfections remain in certain scenarios such as hypoglycemia and in certain populations such as young children. Ongoing research on sensors and calibration software should translate to better systems.Current opinion in endocrinology, diabetes, and obesity 04/2013; 20(2):106-11. · 3.77 Impact Factor