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

• Published in: Wiener Klinische Wochenschrift 2014-04, Vol.126 (7-8), p.228-237
• Main Authors: Zdarska, Denisa Janickova, Kvapil, Milan, Rusavy, Zdenek, Krcma, Michal, Broz, Jan, Krivska, Bohumila, Kadlecova, Pavla
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose - analysis; Czech Republic; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - diagnosis; Diabetes Mellitus, Type 2 - drug therapy; Drug Monitoring - methods; Drug Substitution; Endocrinology; Female; Gastroenterology; Humans; Hypoglycemic Agents - administration & dosage; Insulin Glargine; Insulin, Isophane - administration & dosage; Insulin, Long-Acting - administration & dosage; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Original Article; Pneumology/Respiratory System; Reproducibility of Results; Sensitivity and Specificity; Treatment Outcome; Young Adult
• ISSN: 0043-5325; 1613-7671
• DOI: 10.1007/s00508-014-0508-6

Summary Backround 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]. Methods This was a multicenter, prospective, open-label, single-arm study in patients ( N  = 116) treated for ≥ 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 · h)]. Differences (glargine–NPH) in AUC within 24 h in the glucose ranges of ≤ 3.3, ≤ 3.9, 7.5–3.9 (margins excluding), ≥ 7.5, ≥ 10, and ≥ 15 mmol/L were evaluated. Circadian fluctuation of glucose was assessed by M-value (log-transformation of the deviation from an arbitrary standard). Results AUCs of glucose in the lowest ranges (≤ 3.3 and ≤ 3.9 mmol/L) did not change significantly after treatment with glargine. Those in the higher ranges (≥ 7.5, ≥ 10, and ≥ 15 mmol/L) were significantly lower ( p