Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To show that a structured treatment plan based upon Accu-Chek 360 View has a favorable effect
      on physician decision-making and HbA1c for patients on oral hypoglycemic agents (OHA) or
      insulin for type 2 diabetes (T2D).

      Hypothesis 1: Compared to controls, intervention subjects will undergo a greater number of
      medication changes and have a lower HbA1 at the conclusion of the study.

      Hypothesis 2: Higher rates of monitoring at entry will be associated with lower CHO
      consumption, lower percent body fat, higher medication compliance, and higher physical
      activity levels.

      Hypothesis 3: Patients with lower rates of monitoring at entry will have higher rates of
      depression, more likely to have an external locus of control, and express greater fear about
      self-testing.
    

Detailed description: 
      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.
    

Intervention name(s): Targeted Self-Monitoring Of Blood Glucose (SMBG); Provider Training; Patient Education
Intervention type(s): Other; Other; Other
Intervention description(s): SMBG will alternate between 2 strategies: glucose profiling and target monitoring.; Focused on normalizing the most significant glucose abnormalities at any given time.; Focused on normalizing the most significant glucose abnormalities at any given time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glucose; Diabetes Mellitus, Type 2; HbA1c