Psychosocial – Behavioral Medicine Presented on Saturday, June 9, 2012 11:30 AM

Author(s):  MARCIAA. TESTA, JASVINDER K. GILL, MAXWELL SU, LOUISE TRAYLOR, DONALD C. SIMONSON, Boston, MA, Bridgewater, NJ, Wellesley, MA. It is generally accepted that higher glucose levels and fluctuations in T1DM have a negative impact on patient satisfaction, compliance and symptom distress, yet rigorous data documenting these associations are lacking. We conducted a T1DM subgroup analysis of a randomized cross-over (12 wk phases) trial (NCT00135941) of open-label daily insulin glargine plus premeal insulin glulisine (GG) or bid premix insulin 75/25 or 70/30 (PM) requiring titration to HbA1c < 7.0% in 52 US centers using blinded continuous glucose monitoring (CGM) and patient reports. Three-day CGM (288 glucoses/day) and HbA1c were obtained at wks 0, 12 and 24, and questionnaires completed at wks 0, 8, 12, 20 and 24 in 82 patients: 56.1% men, mean (SD) age = 44.4 (12.6) y, HbA1c = 7.6 (0.6) %, DM duration = 21.6 (12.0) y. Data were analyzed using longitudinal linear mixed models. For GG vs PM, mean (SE) HbA1c [7.2 (0.1) vs 7.6 (0.1) % (P < 0.0001)]; CGM mean [153.5 (4.4) vs 167.9 (4.6) mg/dL (P = 0.025)]; and CGM SD [57.1 (2.6) vs 63.5 (2.1) mg/dL (P = 0.033)] were lower for GG with similar rates of hypoglycemia. Satisfaction Net Benefit scale [56.2 (2.6) vs 28.5 (2.6)] and its subscales of advocacy, preference, effectiveness and general satisfaction were higher for GG (P < 0.0001). The Regimen Acceptance scale favored GG [64.6 (1.3) vs 60.6 (1.3); P = 0.033] as did its subscales of flexibility, hassle, side effects and life interference (P = 0.03 to P < 0.0001). The pain with injections subscale favored PM (P = 0.022). QOL (1-10) rating (P < 0.05) and Diabetes Interference Scales (P = 0.002) favored GG. Symptom Distress favored GG due primarily to 6 symptoms reflecting reduced hyper- and hypoglycemia (P < 0.0001 to P = 0.041). No symptoms favored PM. Although basal-bolus regimens are perceived as burdensome, patient acceptance and satisfaction were driven more by positive health and quality-of-life outcomes associated with improved glycemic control and variability during insulin intensification with GG versus PM

Disclosure:  M.A. Testa: None. J.K. Gill:Employee; Author; sanofi-aventis. M. Su: None. L. Traylor:Employee; Author; sanofi-aventis. D.C. Simonson: None. View abstract at – https://ada.scientificposters.com/index.cfm?k=fekbk088am