Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients (CONGO)

patients of assorted practices

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 and not older than 75 years

• 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 USB regularly (TEST subjects only)
  • Using the Trends feature in CONTOUR USB regularly (TEST subjects only)
  • Uploading the CONTOUR 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 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 6 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