A1c Control in a Primary Care Setting: Self-titrating an Insulin Analog Pre-mix (INITIATEplus Trial)
Purpose: To study glycemic control and hypoglycemia development upon initiation of insulin through a self-titration schedule in a 24-week trial, conducted with 4875 insulin-naïve patients with poorly controlled type 2 diabetes, predominantly in a primary care setting.
Methods: Subjects initiated twice-daily biphasic insulin aspart 70/30 with 6 units prebreakfast and 6 units presupper, self-titrating according to self-measured blood glucose values. Subjects were randomized (1:1:1) to telephone counseling provided by a registered dietician: no counseling (NC), 1 counseling session (1C), or 3 sessions (3C).
Results: Mean baseline HbA1c (9.9% across groups) decreased ∼2.5% to 7.49%±1.48, 7.48%±1.50, and 7.44%±1.46 in the NC, 1C, and 3C groups, respectively. Within these groups, a hemoglobin A1c (HbA1c) value <7% was achieved by 40.2%, 41.6%, and 41.8% of subjects, respectively. Eight-point blood glucose profiles were substantially improved from baseline for all groups. Hypoglycemia was experienced by 10.2%-11.4% of the subjects in each group. Rates of minor and major hypoglycemia were low but decreased as dietary counseling increased (minor hypoglycemia: 56 vs 50 vs 45 episodes per 100 patient-years; major hypoglycemia, 9 vs 6 vs 4 episodes per 100 patient-years, for the NC vs 1C vs 3C groups, respectively; P <.001, 3C vs NC). Weight increased by 3.13, 3.40, and 2.88 kg for the NC, 1C, and 3C groups, respectively.
Conclusion: In the primary care setting, self-titration of biphasic insulin aspart 70/30 was effective in achieving recommended HbA1c goals even with minimal dietary counseling.