Title: Comparison of Continuous Blood Glucose Measurement with Conventional Documentation of Hypoglycemia in Patients with Type 2 Diabetes on Multiple Daily Insulin Injection Therapy
Abstract: Background: The primary objective of this study was to investigate the difference in the proportion of patients with conventionally detected hypoglycemia compared with continuous glucose monitoring system (CGMS®, Medtronic MiniMed®, Sylmar, CA)-detected glucose values ≤60 mg/dL (≤3.3 mmol/L), during the 72-h CGMS measurement period after 8 weeks' treatment with insulin glargine. Methods: This was a multicenter (n = 125), open-label, single-arm study in patients with Type 2 diabetes mellitus (T2DM) on multiple daily injections. Patients received NPH insulin (2-week run-in) followed by glargine (8-week treatment phase). Glucose levels were measured by CGMS and self-monitored blood glucose (SMBG) profiles over the 72-h pre- and post-treatment phase. Results: The full analysis set contained 367 patients [male 59%; mean age 59.2 years; mean body mass index 31.7 kg/m2; mean hemoglobin A1c (HbA1c) 6.9%]. At end point, 209 patients (56.9%) experienced hypoglycemia according to CGMS; 97 (26.4%) recorded hypoglycemia by conventional methods. CGMS- and SMBG-determined mean daytime glucose levels were similar at baseline and end point; however, nocturnal glucose levels were significantly lower with CGMS versus SMBG at baseline [130.2 vs. 145.0 mg/dL (7.2 vs. 8.1 mmol/L)] and at end point [123.3 vs. 137.3 mg/dL (6.8 vs. 7.6 mmol/L)]. Glucose levels measured by CGMS and SMBG decreased, and HbA1c levels decreased from 6.90% at screening to 6.67% at end point (P < 0.001). Conclusions: This study demonstrates that CGMS can be successfully employed in large clinical trial settings in patients with T2DM. This easy-to-implement method may provide additional insights into glucose levels and valuable information regarding the time patients spend within the preferred glucose range.
Publication Year: 2007
Publication Date: 2007-11-22
Language: en
Type: article
Indexed In: ['crossref', 'pubmed']
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Cited By Count: 63
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