Context:In patients with diabetes, intraday glucose variability might predict health outcomes independently from glycosylated hemoglobin (HbA 1c ).Objective: Our objective was to evaluate patient satisfaction (PS), quality of life (QoL), glycemic control, and variability during insulin intensification to HbA 1c below 7.0%.Patients, Design, and Setting: Eighty-two type 1 and 306 insulin-treated type 2 diabetes patients (47% male; age 54 Ϯ 11 yr; HbA 1c ϭ 7.8 Ϯ 0.7%) participated in this multicenter, randomized, crossover trial at 52 U.S. centers.
Interventions:Interventions included insulin glargine plus premeal glulisine (n ϭ 192) vs. twice-daily premix 75/25 or 70/30 analog insulin (n ϭ 196) for 12 wk and crossed to the alternate arm for 12 wk.
Main Outcome Measures:Main outcome measures included PS and QoL questionnaires, 3-d continuous glucose monitoring (CGM), and HbA 1c every 4 -8 wk.Results: Mean Ϯ SE HbA 1c change was Ϫ0.39 Ϯ 0.09% for glargine-glulisine and Ϫ0.05 Ϯ 0.09% for premix (P Ͻ 0.0001). The PS net benefit scale (0 -100) improved from 51.1 to 60.5 Ϯ 1.2 for glargineglulisine and worsened to 45.4 Ϯ 1.2 for premix (P Ͻ 0.0001). The PS regimen acceptance scale was comparable (P ϭ 0.33). Overall QoL favored glargine-glulisine (P Ͻ 0.001), as did perceived health (P Ͻ 0.0001), symptom distress (P Ͻ 0.0001), general health perceptions (P Ͻ 0.01), and psychosocial (P Ͻ 0.02). CGM daily glucose mean, daily glucose SD (glycemic variability), and percent time over 140 mg/dl were lower for glargine-glulisine by 13.1 Ϯ 2.7 mg/dl, 5.9 Ϯ 1.4 mg/dl, and 7.3 Ϯ 1.6%, respectively (all P Ͻ 0.0001), with no difference in CGM percent time below 70 mg/dl (P ϭ 0.09). Symptomatic hypoglycemia rates were comparable. HbA 1c , mean CGM daily glucose, and glycemic variability were independent predictors of PS net benefit.
Conclusions:Patient satisfaction was impacted more positively by improved QoL, reduced glucose variability, and better glycemic control with a basal-bolus regimen than negatively by the burden of additional injections, thereby facilitating insulin intensification and the ability to achieve HbA 1c below 7.0%.