Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes

Primary care providers (PCP's) will be randomized to intervention and control arms. Their
T2D patients will be identified by searching computerized pharmacy records for OHA or
insulin, followed until they are on a stable medical regimen, and eligible to participate if
their baseline HbA1c is 7.0 - 9.5% if on OHA or 7.5 - 10.0% if on insulin. Two sample
frames will be created for intervention patients: one of patients on OHA alone and one of
patients on insulin alone or in combination with OHA. The same procedure will be used to
develop corresponding sample frames for control patients. OHA patients will be randomly
sampled from the intervention and control groups at a ratio of 1:1 until 174 subjects have
been enrolled. Insulin patients will be recruited in the same manner until another 174
subjects are recruited. At entry, patients will have measurements of fat mass,
insulin-resistance, stimulated C-peptide, carbohydrate intake, and physical activity level.

The intervention will consist of targeted SMBG, provider training, and patient education,
all of which will be focused on normalizing the most significant glucose abnormalities at
any given time. SMBG will alternate between 2 strategies: glucose profiling and target
monitoring. Intervention PCP's will use 360 View to identify a patient's most significant
glucose elevation(s) and devise a treatment plan that includes the medication to be used,
starting dose, dose increment per cycle, interval between dose increases, monitoring times
and frequency, goal for the target, and stop criteria. Separate treatment protocols will be
recommended for OHA patients with basal hyperglycemia, OHA patients with PP hyperglycemia,
insulin patients with basal hyperglycemia, and insulin patients with PP hyperglycemia.
Treatment will conform to current standards of practice as defined by package inserts and
Micromedex, the VA's official on-line drug reference. Subjects will repeat the dose
titration cycle under the guidance of a case manager until the target is reached, maximal
recommended doses of medications are used, or a stop criterion is met. They will then
resume glucose profiling to identify the next target. This process is repeated until all
targets reach their optimal value. Intervention subjects will undergo no less than 4 cycles
in 48 weeks. Control patients will monitor and be treated in the customary manner.