850-P — 2012: Assessing the Comparative Effectiveness (CE) of Basal-Bolus vs. Premix Insulin Using Continuous Glucose Monitoring (CGM) Summary Measures

Clinical Therapeutics/New Technology – Glucose Monitoring and Sensing Presented on Sunday, June 10, 2012 12:00 PM

Author(s):  DONALD C. SIMONSON, JASVINDER K. GILL, MAXWELL SU, LOUISE TRAYLOR, MARCIAA. TESTA, Boston, MA, Bridgewater, NJ, Wellesley, MA. CGM is an effective management and diagnostic tool that also can be used to assess the CE of diabetes regimens. We analyzed CGM data collected from type 2 diabetes (T2DM) patients in 52 US centers during a randomized, open-label, cross-over (12 wk phases) trial (NCT00135941) of daily insulin glargine plus premeal insulin glulisine (GG) or premix insulin 75/25 or 70/30 bid (PM) requiring titration to HbA1c < 7.0% to evaluate the utility of CGM in CE research. Three-day CGM (288 glucoses/day), HbA1c and patient-reported satisfaction were obtained at wks 0, 12 and 24 in 306 patients [45.1% men; mean (SD) age = 56.1 (9.3) y; HbA1c = 7.8 (0.7) %; diabetes duration = 14.5 (8.1) y]. Data were analyzed using longitudinal linear mixed models. Mean (SE) HbA1c decreased by 0.6 (0.1) for GG and 0.3 (0.1) % for PM (P < 0.0001). There was a more favorable CGM profile for GG compared to PM (Table). Measures of low blood glucose risk (AUC < 70 mg/dL) and Low Blood Glucose Index were not different. After adjusting for treatment, period, sequence, week, baseline satisfaction, BMI, age, HbA1c < 7.0%, mean daily insulin dose and duration of diabetes, each CGM measure proved to be an independent predictor of treatment satisfaction (all P < 0.0001). Changes in CGM summary measures differentiated GG and PM regimens in terms of glycemic variability and risk independent of changes in HbA1c, and predicted patient-reported treatment satisfaction. CGM summary measures can enhance comparative effectiveness research in diabetes by providing information on daily glucose variability that cannot be obtained from HbA1c alone.

CGM Summary Measure [Mean (SE)]GGPMP
24-hr glucose change from baseline (mg/dL)-28.8 (3.7)-11.9 (3.9)0.002
Within-Day SD (mg/dL)46.3 (1.1)49.7 (1.1)0.019
AUC > 180 mg/dL (hrs x mg/dL)16.3 (1.2)20.0 (1.2)0.033
Time within 70 to 130 mg/dL (hrs)8.8 (0.3)7.7 (0.3)0.007
Glycemic Risk Assessment Diabetes Equation8.3 (0.2)9.2 (0.3)0.013
High Blood Glucose Index6.8 (0.3)7.9 (0.3)0.018

Disclosure:  D.C. Simonson: None. J.K. Gill:Employee; Author; sanofi-aventis. M. Su: None. L. Traylor:Employee; Author; sanofi-aventis. M.A. Testa: None. View abstract at –  https://ada.scientificposters.com/index.cfm?k=4s4vi4awu2


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