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

• Published in: Diabetes care Vol. 37; no. 3; pp. 604 - 610
• Main Authors: HARRIS, Stewart B, YALE, Jean-François, BERARD, Lori, STEWART, John, ABBASZADEH, Babak, WEBSTER-BOGAERT, Susan, GERSTEIN, Hertzel C
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Diabetes Association 01.03.2014
• Subjects: Adult; Aged; Algorithms; Biological and medical sciences; Blood Glucose - drug effects; Blood Glucose Self-Monitoring; Care and treatment; Comparative analysis; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Diabetes therapy; Diabetes. Impaired glucose tolerance; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Female; Glucose; Glycated Hemoglobin A - metabolism; Glycemic index; Health participants; Humans; Hypoglycemia - drug therapy; Hypoglycemic Agents - administration & dosage; Insulin; Insulin - administration & dosage; Insulin - analogs & derivatives; Insulin Glargine; Insulin, Long-Acting - administration & dosage; Male; Medical sciences; Metabolic diseases; Methods; Middle Aged; Patient outcomes; Physicians; Public health. Hygiene; Public health. Hygiene-occupational medicine; Self Administration; Self-care, Health; Treatment Outcome; Type 2 diabetes; Endocrinopathy; Human; Glycemic control; Nutrition; Health staff; Physician; Patient; Metabolic diseases; Self; Insulin glulisine; Result; Target tissue resistance; Target; Hypoglycemic agent; Randomization; Insulin glargine; Clinical trial; Insulin resistance; Strategy; Endocrinology; Glycemia
• ISSN: 0149-5992; 1935-5548; 1935-5548
• DOI: 10.2337/dc13-1636

OBJECTIVE Diabetes 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 METHODS Patients with type 2 diabetes, an HbA1c 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 HbA1c level ≤7% (53 mmol/mol) without severe hypoglycemia. RESULTS After 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 HbA1c 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). CONCLUSIONS In 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.