Real Time Continuous Glucose Monitoring
In this cross-sectional study conducted in January 2010, we included diabetic patients who were using a RT-CGM device in the Netherlands for at least 3 months continuously (figure 1).
(Enlarge Image)
Figure 1.
Real time continuous glucose monitors (manufactured by (a) Abbott and (b) Medtronic)
Providers of RT-CGM, Medtronic Inc. (Minneapolis, MN, USA) and Abbott Diabetes Care Inc (Alameda USA), informed all registered users of the experimental nature of the use of RT-CGM and the request to collect data to assess its benefit, safety and tolerability in daily life. After informed consent patients were provided with a code to fill out a questionnaire via an email link to our website or anonymously by mail.
The questionnaire was specifically designed for this study and included questions on type and duration of diabetes, self-reported complications, subjective reasons for RT-CGM use, as well as regarding the source of payment of RT-CGM, income, perceived problems with use of the sensor, time on the sensor, but also information such as perceived burden of diabetes, admissions for severe hypoglycaemia or ketoacidosis, and so on, before and since use. We checked and verified all items in the sample of our own participants (n=30), as follows. First, anthropometric and disease- and treatment-related data and the items related to hospital admissions were verified from patient case-record forms by one of the investigators (JvN). Second, with regard to the more subjective items (as provided in Table 2, such as compliance and patient satisfaction), we verified this in our own population by interviewing all patients and checking historic remarks on these items in our electronic diabetes patient file. Accordingly, we did not detect major discrepancies between the answers provided in the questionnaire and those verified in the interviews.
For each participant, serial HbA1c measurements were performed in their own hospital's routine laboratory, using standardised methods. These values were reported in the questionnaire and verified by the patient's care providers. Patients were instructed to calibrate the CGM by entering their self-measured blood glucose values at the indicated time-points. CGM measurements were extracted from the sensor via the software provided by Abbott and Medtronic.
Continuous parameters were expressed as mean ± s.d. when normally distributed and as median (interquartile range) in case of a skewed distribution. Categorical results were expressed as percentages. Student T-test was used to compare differences between groups for continuous data and Mann-Whitney-U test for non-parametric variables. A p-value of 0.05 was considered as statistic significant.
Data were analysed using SPPS 16.0 (SPSS Inc. Chicago IL, USA). Two-sided Fisher's exact test or Chi-square test was used to assess differences at the 5% significance level
Methods
In this cross-sectional study conducted in January 2010, we included diabetic patients who were using a RT-CGM device in the Netherlands for at least 3 months continuously (figure 1).
(Enlarge Image)
Figure 1.
Real time continuous glucose monitors (manufactured by (a) Abbott and (b) Medtronic)
Providers of RT-CGM, Medtronic Inc. (Minneapolis, MN, USA) and Abbott Diabetes Care Inc (Alameda USA), informed all registered users of the experimental nature of the use of RT-CGM and the request to collect data to assess its benefit, safety and tolerability in daily life. After informed consent patients were provided with a code to fill out a questionnaire via an email link to our website or anonymously by mail.
The questionnaire was specifically designed for this study and included questions on type and duration of diabetes, self-reported complications, subjective reasons for RT-CGM use, as well as regarding the source of payment of RT-CGM, income, perceived problems with use of the sensor, time on the sensor, but also information such as perceived burden of diabetes, admissions for severe hypoglycaemia or ketoacidosis, and so on, before and since use. We checked and verified all items in the sample of our own participants (n=30), as follows. First, anthropometric and disease- and treatment-related data and the items related to hospital admissions were verified from patient case-record forms by one of the investigators (JvN). Second, with regard to the more subjective items (as provided in Table 2, such as compliance and patient satisfaction), we verified this in our own population by interviewing all patients and checking historic remarks on these items in our electronic diabetes patient file. Accordingly, we did not detect major discrepancies between the answers provided in the questionnaire and those verified in the interviews.
For each participant, serial HbA1c measurements were performed in their own hospital's routine laboratory, using standardised methods. These values were reported in the questionnaire and verified by the patient's care providers. Patients were instructed to calibrate the CGM by entering their self-measured blood glucose values at the indicated time-points. CGM measurements were extracted from the sensor via the software provided by Abbott and Medtronic.
Continuous parameters were expressed as mean ± s.d. when normally distributed and as median (interquartile range) in case of a skewed distribution. Categorical results were expressed as percentages. Student T-test was used to compare differences between groups for continuous data and Mann-Whitney-U test for non-parametric variables. A p-value of 0.05 was considered as statistic significant.
Data were analysed using SPPS 16.0 (SPSS Inc. Chicago IL, USA). Two-sided Fisher's exact test or Chi-square test was used to assess differences at the 5% significance level
SHARE
