An interventional study of Integrated sensor and infusion set. in Diabetes Type 1, sponsored by Medtronic Diabetes R&D Denmark. Completed at 1 site in Denmark. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-02-05.
Sponsored by Medtronic Diabetes R&D Denmark · Not applicable, Interventional, and Basic science
The purpose of this study is to collect performance data on the integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the Integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy.
Sensor clinical accuracy will be evaluated based on the following parameters: Mean ARD (absolute relative difference), median ARD, Clarke Grid Analysis. Meter BG values will be used as reference. Descriptive statistics will be used to assess non-inferiority of the Integrated sensor and infusion sets sensors compare to control Enlite sensors.
Insulin delivery functionality will be evaluated based on BG profiles obtained during peri-prandial periods during which BG measurements will be performed at 15, 20, 30 min intervals according to a SMBG schedule. Post-prandial pharmacodynamic profiles will be analyzed to demonstrate the effect of insulin delivered using the Integrated sensor and infusion set. Specifically, rise in glucose levels followed by their fall will be used as an indication that insulin was delivered and absorbed. Post-prandial BG areas under the curve (AUC), Tmax (time to maximum rise of BG), and Cmax (maximum post-prandial BG) values will be calculated for each meal (breakfast, lunch, and dinner) consumed during both inpatient days and compared. Intra - and inter-subject mean values and standard deviations will be calculated. Paired and unpaired T-tests will be used to evaluate statistical significance.
Longevity of device performance will be assessed by comparing the listed parameters obtained during two inpatient days.
3,521 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 2,648 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medtronic Diabetes R&D Denmark is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects must have been previously diagnosed Type 1 Diabetics and being used to sensor augumented pumps
Device: Integrated sensor and infusion set.
Change patients from current devices to the Integrated sensor and infusion set.
Comparative analysis of performance characteristics
Sensor clinical accuracy will be evaluated based on the following parameters: Mean ARD (absolute relative difference), median ARD, Clarke Grid Analysis. Meter BG values will be used as reference. Descriptive statistics will be used to assess non-inferiority of the Integrated sensor and infusion set sensors compare to control Enlite sensors.
Time frame: 4 months
Gluco-dynamic effect
Insulin delivery functionality will be evaluated based on BG profiles obtained during peri-prandial periods during which BG measurements will be performed at 15, 20, 30 min intervals according to the SMBG schedule. Post-prandial pharmacodynamic profiles will be analyzed to demonstrate the effect of insulin delivered using the Integrated sensor and infusion set. Specifically, rise in glucose levels followed by their fall will be used as an indication that insulin was delivered and absorbed. Post-prandial BG areas under the curve (AUC), Tmax (time to maximum rise of BG), and Cmax (maximum post-prandial BG) values will be calculated for each meal (breakfast, lunch, and dinner) consumed during both inpatient days (visits 3 and 4) and compared. Intra - and inter-subject mean values and standard deviations will be calculated. Paired and unpaired T-tests will be used to evaluate statistical significance.
Time frame: 4 months
Performance longevity
Longevity of device performance will be assessed by comparing the listed parameters obtained during visits 3 and 4.
Time frame: 4 months
Skin condition
Skin condition after removal of the device will be evaluated and assessed by the clinical staff in a study survey
Time frame: 4 months
Physical duration
Investigational Center and subject's report on physical duration of the device assessed in study survey Subjects' experiences are gathered in study surveys.
Time frame: 4 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Medtronic Diabetes R&D Denmark