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Impact of Active Versus Usual Algorithmic Titration of Basal Insulin and Point-of-Care Versus Laboratory Measurement of HbA_1c on Glycemic Control in Patients With Type 2 Diabetes

The Glycemic Optimization with Algorithms and Labs at Point of Care (GOAL A1C) trial

¹ Division of Endocrinology, Department of Medicine, University of Florida, Gainesville, Florida
² Department of Internal Medicine and Epidemiology, University of Michigan Health System, Ann Arbor, Michigan
³ sanofi-aventis, Bridgewater, New Jersey

Address correspondence and reprint requests to Laurence Kennedy, MD, Professor and Chief, Division of Endocrinology, Department of Medicine, Shands Hospital at the University of Florida, Gainesville, FL 32610. E-mail: kenneal{at}medicine.ufl.edu

OBJECTIVE—The objective of this study was to assess the impact of active versus usual monitoring of algorithmic insulin titration and point-of-care (POC) versus laboratory HbA_1c (A1C) measurement on glycemic control in primary care.

RESEARCH DESIGN AND METHODS—The Glycemic Optimization with Algorithms and Labs at Point of Care (GOAL A1C) study was a 24-week, randomized, parallel-group, four-arm, open-label study of 7,893 adults with type 2 diabetes uncontrolled by oral antidiabetic agents and requiring insulin. Patients were randomly assigned by investigators from 2,164 sites in the U.S. to insulin glargine with either 1) usual (no unsolicited contact between visits) insulin titration using a simple algorithm with laboratory A1C testing, 2) usual titration with POC A1C testing, 3) active (weekly monitored) titration with laboratory A1C testing, or 4) active titration with POC A1C testing. Outcome measures included a change in A1C and fasting self-monitoring of blood glucose (SMBG) levels, percentage of patients achieving A1C <7.0%, and hypoglycemia frequency.

RESULTS—Significant A1C and SMBG reductions were observed in all arms (P < 0.0001). Compared with usual insulin titration, active titration achieved greater A1C reduction (1.5 vs. 1.3%; P < 0.0001), SMBG reduction (88 vs. 79 mg/dl; P < 0.0001), and proportion of patients achieving A1C <7.0% (38 vs. 30%; P < 0.0001). Among patients receiving active titration, POC A1C testing was associated with an increase in the proportion achieving an A1C <7.0% (41% for POC vs. 36% for laboratory; P < 0.0001). Hypoglycemia rates were low (usual vs. active groups: 3.7 vs. 6.0 all confirmed episodes/patient-year [P < 0.001]; 0.09 vs. 0.14 severe episodes/patient-year [NS]).

CONCLUSIONS—In a predominantly primary care setting, addition of insulin glargine using a simple algorithm achieved significant improvements in glycemic control in patients with type 2 diabetes in all four study arms. Active titration resulted in significant incremental improvements in glycemic control, and, among patients receiving active titration, POC A1C testing resulted in a greater portion achieving A1C <7.0%.

Abbreviations: GOAL A1C, Glycemic Optimization with Algorithms and Labs at Point of Care • ITT, intent to treat • LOCF, last observation carried forward • POC, point of care • SMBG, self-monitoring of blood glucose • TEAE, treatment-emergent adverse event • TZD, thiazolidinedione

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