Comparison of glucose variability assessed by a continuous glucose-monitoring system in patients with type 2 diabetes mellitus switched from NPH insulin to insulin glargine: The COBIN2 study
Abstract
Glucose variability combined with glycosylated hemoglobin (HbA1c) assessments more reliably represents the level of glycemic control. The study was aimed to compare blood glucose variability with insulin glargine vs. neutral protamine Hagedorn (NPH) in patients with type 2 diabetes mellitus using a continuous glucose-monitoring system (CGMS), in patients treated with basal insulin using stable dose of oral antidiabetic agents and HbA1c in the range of 4.5-8.0 % International Federation of Clinical Chemistry (IFCC) units. [6.2-9.4 % Diabetes Control and Complications Trial (DCCT) units].
This was a multicenter, prospective, open-label, single-arm study in patients (N = 116) treated for a parts per thousand yenaEuro parts per thousand 2 months with NPH and metformin combined with sulfonylurea or glinide. Glucose variability was measured after a 4-week NPH treatment phase and after a subsequent 12-week glargine treatment phase using CGMS.
Based on 72-hour CGMS, glucose variability was assessed by area under the curve [AUC (mmol/L center dot h)]. Differences (glargine-NPH) in AUC within 24 h in the glucose ranges of a parts per thousand currency signaEuro parts per thousand 3.3, a parts per thousand currency signaEuro parts per thousand 3.9, 7.5-3.9 (margins excluding), a parts per thousand yenaEuro parts per thousand 7.5, a parts per thousand yenaEuro parts per thousand 10, and a parts per thousand yenaEuro parts per thousand 15 mmol/L were evaluated.
Circadian fluctuation of glucose was assessed by M-value (log-transformation of the deviation from an arbitrary standard).