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

Completed

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT01588106
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2012-06
• Primary Completion: 2015-10
• Status Verified: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2017-01-19
• Results First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Results First Posted: 2017-03-09
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in HbA1c	Baseline, after 9 months

Trial Locations

Locations (16)

Gemeinschaftspraxis Lorra/Bonnermann; 🇩🇪 Bochum, Germany

Diabetespraxis Prenzlauer Allee; 🇩🇪 Berlin, Germany

Praxis Dr. Holderied; 🇩🇪 Brand-Erbisdorf, Germany

Praxis Dr. Fießelmann; 🇩🇪 Berlin, Germany

Spreewaldklinik; 🇩🇪 Burg, Germany

Studienzentrum Prof. Hanefeld; 🇩🇪 Dresden, Germany

Diabeteszentrum DO; 🇩🇪 Dortmund, Germany

Praxis Dr. Stier; 🇩🇪 Freital, Germany

Gemeinschaftspraxis Schaden; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Dresden, Medizinische Klinik III; 🇩🇪 Dresden, Germany

SMO.MD GmbH; 🇩🇪 Magdeburg, Germany

Diabeteszentrum Oschatz; 🇩🇪 Oschatz, Germany

Praxis Dr. Ruhland; 🇩🇪 München, Germany

Praxis Dr. Engelmayer; 🇩🇪 München, Germany

Metabolicum; 🇩🇪 München, Germany

Praxis Dr. Stephan; 🇩🇪 Berlin, Germany