Comparative Effectiveness of Basal-Bolus Versus Premix Analog Insulin on Glycemic Variability and Patient-Centered Outcomes during Insulin Intensification in Type 1 and Type 2 Diabetes: A Randomized, Controlled, Crossover Trial

Context: In patients with diabetes, intraday glucose variability might predict health outcomes independently from glycosylated hemoglobin (HbA1c). Objective: Our objective was to evaluate patient satisfaction (PS), quality of life (QoL), glycemic control, and variability during insulin intensificati...

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Published in:	The journal of clinical endocrinology and metabolism 2012-10, Vol.97 (10), p.3504-3514
Main Authors:	Testa, Marcia A, Gill, Jasvinder, Su, Max, Turner, Ralph R, Blonde, Lawrence, Simonson, Donald C
Format:	Article
Language:	eng
Subjects:	Adult Aged Biological and medical sciences Blood Glucose - drug effects Body Weight - drug effects Cross-Over Studies Diabetes Mellitus, Type 1 - drug therapy Diabetes Mellitus, Type 2 - drug therapy Diabetes. Impaired glucose tolerance Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Feeding. Feeding behavior Female Follow-Up Studies Fundamental and applied biological sciences. Psychology Glycated Hemoglobin A - metabolism Humans Hypoglycemia - chemically induced Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Insulin - administration & dosage Insulin - adverse effects Insulin - analogs & derivatives Insulin Glargine Insulin, Long-Acting - administration & dosage Insulin, Long-Acting - adverse effects Male Medical sciences Middle Aged Patient Satisfaction Quality of Life Surveys and Questionnaires Vertebrates: anatomy and physiology, studies on body, several organs or systems Vertebrates: endocrinology
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Summary:	Context: In patients with diabetes, intraday glucose variability might predict health outcomes independently from glycosylated hemoglobin (HbA1c). Objective: Our objective was to evaluate patient satisfaction (PS), quality of life (QoL), glycemic control, and variability during insulin intensification to HbA1c below 7.0%. Patients, Design, and Setting: Eighty-two type 1 and 306 insulin-treated type 2 diabetes patients (47% male; age 54 ± 11 yr; HbA1c = 7.8 ± 0.7%) participated in this multicenter, randomized, crossover trial at 52 U.S. centers. Interventions: Interventions included insulin glargine plus premeal glulisine (n = 192) vs. twice-daily premix 75/25 or 70/30 analog insulin (n = 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 HbA1c every 4–8 wk. Results: Mean ± se HbA1c change was −0.39 ± 0.09% for glargine-glulisine and −0.05 ± 0.09% for premix (P < 0.0001). The PS net benefit scale (0–100) improved from 51.1 to 60.5 ± 1.2 for glargine-glulisine and worsened to 45.4 ± 1.2 for premix (P < 0.0001). The PS regimen acceptance scale was comparable (P = 0.33). Overall QoL favored glargine-glulisine (P < 0.001), as did perceived health (P < 0.0001), symptom distress (P < 0.0001), general health perceptions (P < 0.01), and psychosocial (P < 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 ± 2.7 mg/dl, 5.9 ± 1.4 mg/dl, and 7.3 ± 1.6%, respectively (all P < 0.0001), with no difference in CGM percent time below 70 mg/dl (P = 0.09). Symptomatic hypoglycemia rates were comparable. HbA1c, 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 HbA1c below 7.0%.
ISSN:	0021-972X 1945-7197