Does a Patient-Managed Insulin Intensification Strategy With Insulin Glargine and Insulin Glulisine Provide Similar Glycemic Control as a Physician-Managed Strategy? Results of the START (Self-Titration With Apidra to Reach Target) Study A Randomized Noninferiority Trial

OBJECTIVEDiabetes self-management is universally regarded as a foundation of diabetes care. We determined whether comparable glycemic control could be achieved by self-titration versus physician titration of a once-daily bolus insulin dose in patients with type 2 diabetes who are unable to achieve optimal glycemia control with a basal insulin.RESEARCH DESIGN AND METHODSPatients with type 2 diabetes, an HbA(1c) level >7% (53 mmol/mol), and either nocturnal hypoglycemia episodes or an insufficient basal insulin glargine level (with or without oral agents) to achieve a fasting plasma glucose level 6 mmol/L (108 mg/dL) were studied. Participants all had bolus insulin glulisine added at breakfast and were allocated to either algorithm-guided patient self-titration or physician titration. The primary outcome was an HbA(1c) level 7% (53 mmol/mol) without severe hypoglycemia.RESULTSAfter a mean (SD) follow-up of 159.4 days (36.2 days), 28.4% of participants in the self-titration arm vs. 21.2% in the physician titration arm achieved an HbA(1c) level of 7% (53 mmol/mol) without severe hypoglycemia (between-group absolute difference 7.2%; 95% CI -3.2 to 17.7). The lower end of this 95% confidence interval was within the predetermined noninferiority boundary of -5% (P noninferiority = 0.011).CONCLUSIONSIn stable patients with type 2 diabetes who are receiving doses of basal insulin glargine who require bolus insulin, a simple bolus insulin patient-managed titration algorithm is as effective as a physician-managed algorithm.