ACCU-CHEK Aviva Expert Study: Does Use of an Insulin Bolus Advisor Improve Glycemic Control in Patients Failing MDI/ICT?

Inclusion Criteria:

• must be 18 years of age or older
• diagnosed with Type 1 or Type 2 diabetes
• recent HbA1c > 7.5% (measured within the last 6 weeks at local laboratory)
• on MDI therapy for at least 6 months consisting of 1-2 injections per day of long-acting basal insulin (Lantus® or Detemir®) and at least 2 injections per day of regular or rapid-acting analog insulin for meal coverage
• Subject adjusts meal insulin doses based on carbohydrate content of meals
• Subject with Type 2 diabetes may be on stable metformin therapy (therapy unchanged during 3 months prior to study)
• Subject has been in Investigator's practice for at least 3 months; however may have been seen by another physician in the practice
• Subject has completed carbohydrate (CHO) training within the last 2 years

Exclusion Criteria:

• Subject is on a therapy regimen that conflicts with study:
• NPH or pre-mixed insulin
• Oral anti-diabetic agents, with the exception of metformin
• Injectable anti-diabetic agents other than long-acting insulin and rapid-acting insulin analogs or regular insulin (e.g., fixed dose therapy)
• Use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific bG results
• Subject has participated in another interventional trial within 6 weeks prior to study
• Subject has been diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion)
• Subject has used systemic oral or inhaled steroids for more than 7 days within the last 3 months
• Subject is on Chemotherapy or Radiation therapy (self-reported)
• Subject is pregnant or lactating or is currently planning a pregnancy.