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

Diabetes Mellitus Type 2 Clinical Trial

— CONGO  

Official title:

Evaluation of the Impact of the CONTOUR® USB Blood Glucose Monitoring System With Integrated Data Management on Glycaemic Control in Insulin-treated Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588106
• Other study ID #: GWT-2011-1
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: January 21, 2016
• Start date: June 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Germany	Diabetespraxis Prenzlauer Allee	Berlin
Germany	Praxis Dr. Fießelmann	Berlin
Germany	Gemeinschaftspraxis Lorra/Bonnermann	Bochum
Germany	Praxis Dr. Holderied	Brand-Erbisdorf
Germany	Spreewaldklinik	Burg
Germany	Diabeteszentrum DO	Dortmund
Germany	Studienzentrum Prof. Hanefeld	Dresden
Germany	Universitätsklinikum Dresden, Medizinische Klinik III	Dresden
Germany	Gemeinschaftspraxis Schaden	Düsseldorf
Germany	Praxis Dr. Stier	Freital
Germany	SMO.MD GmbH	Magdeburg
Germany	Metabolicum	München
Germany	Praxis Dr. Engelmayer	München
Germany	Praxis Dr. Ruhland	München
Germany	Diabeteszentrum Oschatz	Oschatz

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in HbA1c		baseline, after 9 months	No