The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in HbA1c as primary endpoint.

Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be trained in using the devices and return every 3 months until month 9 after baseline.

Inclusion Criteria:

• Type 2 diabetes

• Therapy with insulin only (ICT) or ICT in combination with Metformin

• HbA1c at baseline > 7.5% and < 11%

• Patients at least 18 years of age

• Patients willing to complete all study visits and study procedures including:

  • Testing their BG at least 3 times a day during the entire study.
  • Using the paper logbook provided (control group)
  • Using the Auto log meal-marker + reminder feature in CONTOUR Next USB regularly (TEST subjects only)
  • Using the Trends feature in CONTOUR Next USB regularly (TEST subjects only)
  • Uploading the CONTOUR Next USB meter to personal computer (subject must have personal computer at home or access to a computer - see system requirements in appendix for technical details).

• Patients who are able to speak, read and understand German

• Patients who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more

• Patients who are currently adjusting there insulin dosages themselves based on the self-testing of blood glucose at home

• Written informed consent at beginning of the study

Exclusion Criteria:

• Patients who have been using CONTOUR Next USB meter regularly during the previous 12 months

• Patients treated with oral antidiabetic drugs except for Metformin; or diet alone

• Change of diabetes therapy within the last 3 months

• Change of HbA1c level of more than ±0.5% within the last 3 months

• Patients who are using a continuous blood glucose measurement system regularly

• Patients with home health aides who assist with their BG testing and /or insulin adjustment

• Patients with macroalbuminuria

• Steroid therapy within the last 3 months. Topic or inhalative use is no exclusion criterion when not used regularly (more than 5 times a week).

• Uncontrolled blood pressure ≥ 170/100 at screening

• BMI > 40 kg/m²

• Anemia according to WHO-definition (hemoglobin < 13 g/100 ml [male] or < 12 g/100 ml [female])

• Creatinin > 150 µmol/l and/or GFR < 50 mmol/min/ 1.73m² (measured within the last 3 months before screening)

• Operation with inpatient stay planned during the study

• Current pregnancy or pregnancy planned during the study; or breastfeeding women.

• Women with childbearing potential who are not practicing an acceptable method of birth control. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomized partner

• Alcohol or drug abuse within the last 3 months

• Patients with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:

  • Significant visual impairment
  • Significant hearing impairment
  • Cognitive disorder
  • Significant unstable co-morbidity (with notable change within the past 3 months)
  • Severe renal disease, disease with a strong impact on life expectancy
  • Inability to have or use and computer
  • Inability to use a meter correctly
  • Any other condition as per investigator's discretion

• Current participation in another clinical study. Participation in another trial within 6 weeks before screening.

• Employees of Bayer Vital Diabetes Care, the GWT or the University of Dresden

patients of assorted practices