Diabetes Mellitus Type 2
Conditions
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.
Interventions
None listed
Sponsors
Bayer
GWT-TUD GmbH
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in HbA1c | Baseline, after 9 months |
Countries
Germany
Participant flow
Recruitment details
Subjects were screened and enrolled in 16 sites across Germany. Study start date was in June 2012 and recruitment was stopped in November 2014.
Participants by arm
| Arm | Count |
|---|---|
| Test Group- CONTOUR Next USB Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline. | 73 |
| Control Group- Standard CONTOUR Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline. | 72 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Test Group- CONTOUR Next USB | Control Group- Standard CONTOUR | Total |
|---|---|---|---|
| Age, Continuous | 62.10 Years STANDARD_DEVIATION 10.28 | 65.66 Years STANDARD_DEVIATION 9.08 | 63.87 Years STANDARD_DEVIATION 9.83 |
| HbA1c value at baseline | 8.61 % STANDARD_DEVIATION 0.95 | 8.47 % STANDARD_DEVIATION 0.97 | 8.54 % STANDARD_DEVIATION 0.96 |
| Sex: Female, Male Female | 30 Participants | 36 Participants | 66 Participants |
| Sex: Female, Male Male | 43 Participants | 36 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 78 | 9 / 76 |
| serious Total, serious adverse events | 0 / 78 | 1 / 76 |
Outcome results
Primary
Reduction in HbA1c
Time frame: Baseline, after 9 months
Population: All participants from whom HbA1c measurements were recorded at baseline and after 9 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group- CONTOUR Next USB | Reduction in HbA1c | -0.52 % (unit of HbA1c) | Standard Deviation 0.83 |
| Control Group- Standard CONTOUR | Reduction in HbA1c | -0.14 % (unit of HbA1c) | Standard Deviation 0.94 |