A(1c) control in a primary care setting: self-titrating an insulin analog pre-mix (INITIATEplus trial). DS Oyer, MD Shepherd, FC Coulter, A Bhargava, J Brett, PL Chu, BS Trippe Am J Med 2009 11;122(11):1043-9
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Nov 06, 2009 |
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This study was based on the INITIATE trial, with a goal of repeating that study in primary care, rather than endocrinology, centers in the US. Subjects were randomized to receive different amounts of education in addition to insulin initiation.
HbA1c at entry was 8% or higher, with no upper limit. Secretagogues were stopped but other oral hypoglycemic agents were continued. Premixed analog insulin was initiated with 6 units twice daily before meals. The dose was self-adjusted every 3-5 days based on the average glucose of the preceding 3 days, with a premeal target of 80-110 mg/dL.
The breakfast dose was titrated based on the predinner glucose, and the evening dose was titrated based on the prebreakfast glucose. They were encouraged to titrate one of the doses every 3 to 5 days unless an episode of hypoglycemia had occurred. If hypoglycemia occurred within 24 hours before a scheduled titration, they were to wait at least one more day before adjusting the dose.
HbA1c decreased from 9.9% to 7.4-7.5%, without differentiation by type of education. Surprisingly, only about 40% attained an A1c <7%. Perhaps this was related to the duration of the study (only 24 weeks) or the low dose titration. Final insulin doses were also low, at about 75 units/day, at ~0.7 units/kg/day, keeping in mind that one expects to need around 1-2 units/kg/day of insulin in T2DM.Hypoglycemia was considered to be low at 10-11% (??) but did decrease in incidence with greater dietary intervention.
The clinical utility of this study is that it provides a model for how insulin can easily be initiated in a primary care setting. The biggest challenge is conveying the idea that the morning insulin is titrated based on the evening glucose and that the evening insulin is titrated based on the morning glucose. Kittie Wyne, MD, PhD, FACE
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