BACKGROUND: Subcutaneously infused insulin may interfere with the function of nearby glucose-sensing electrodes and vice versa. The prototype of the Combo-Set device (Medtronic) incorporates a subcutaneous insulin delivery catheter and continuous glucose monitoring (CGM) sensor assembled on the same platform and separated by 11 mm. We aim to evaluate Combo-Set's insulin delivery and glucose-sensing functions. METHODS: Ten subjects with type 1 diabetes wore a Combo-Set and a Sof-Sensor inserted subcutaneously in contralateral abdominal areas connected to iPro recorders (Medtronic) for 53.25 ± 0.75 h (mean ± standard deviation). The Combo-Set delivered insulin diluent except during meal tests on days 1 and 3 when insulin lispro was delivered as a meal bolus and postmeal basal. Venous plasma samples were collected at the following time points from meal start: 0, 30, 60, 120, and 180 min for insulin measurements. The accuracy of the Combo-Set sensors was evaluated and compared with that of the Sof-Sensor, with each referenced against capillary glucose values (Contour Link Meter, Bayer). RESULTS: Accuracy of the Combo-Set sensor was comparable to that of the Sof-Sensor. Clarke error grid analysis showed that 97% of Combo-Set and 93% of Sof-Sensor values were in the A+B regions (p = .20, not significant). The Combo-Set showed the expected postbolus peak insulin time (67 ± 9 min, mean ± standard error). One "no delivery" alarm occurred during the 21 patient days of use. CONCLUSION: A device providing for simultaneous adjacent placement of an insulin infusion catheter and a CGM sensor is feasible and functions within acceptable limits. The low "no delivery" alarm rate was similar to that of other infusion sets.
BACKGROUND: Subcutaneously infused insulin may interfere with the function of nearby glucose-sensing electrodes and vice versa. The prototype of the Combo-Set device (Medtronic) incorporates a subcutaneous insulin delivery catheter and continuous glucose monitoring (CGM) sensor assembled on the same platform and separated by 11 mm. We aim to evaluate Combo-Set's insulin delivery and glucose-sensing functions. METHODS: Ten subjects with type 1 diabetes wore a Combo-Set and a Sof-Sensor inserted subcutaneously in contralateral abdominal areas connected to iPro recorders (Medtronic) for 53.25 ± 0.75 h (mean ± standard deviation). The Combo-Set delivered insulin diluent except during meal tests on days 1 and 3 when insulin lispro was delivered as a meal bolus and postmeal basal. Venous plasma samples were collected at the following time points from meal start: 0, 30, 60, 120, and 180 min for insulin measurements. The accuracy of the Combo-Set sensors was evaluated and compared with that of the Sof-Sensor, with each referenced against capillary glucose values (Contour Link Meter, Bayer). RESULTS: Accuracy of the Combo-Set sensor was comparable to that of the Sof-Sensor. Clarke error grid analysis showed that 97% of Combo-Set and 93% of Sof-Sensor values were in the A+B regions (p = .20, not significant). The Combo-Set showed the expected postbolus peak insulin time (67 ± 9 min, mean ± standard error). One "no delivery" alarm occurred during the 21 patient days of use. CONCLUSION: A device providing for simultaneous adjacent placement of an insulin infusion catheter and a CGM sensor is feasible and functions within acceptable limits. The low "no delivery" alarm rate was similar to that of other infusion sets.
Authors: Jeroen Hermanides; Iris M Wentholt; Augustinus A Hart; Joost B Hoekstra; J Hans DeVries Journal: Diabetes Care Date: 2008-03-10 Impact factor: 19.112
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Authors: William V Tamborlane; Roy W Beck; Bruce W Bode; Bruce Buckingham; H Peter Chase; Robert Clemons; Rosanna Fiallo-Scharer; Larry A Fox; Lisa K Gilliam; Irl B Hirsch; Elbert S Huang; Craig Kollman; Aaron J Kowalski; Lori Laffel; Jean M Lawrence; Joyce Lee; Nelly Mauras; Michael O'Grady; Katrina J Ruedy; Michael Tansey; Eva Tsalikian; Stuart Weinzimer; Darrell M Wilson; Howard Wolpert; Tim Wysocki; Dongyuan Xing Journal: N Engl J Med Date: 2008-09-08 Impact factor: 91.245
Authors: Andrew W Karlin; Trang T Ly; Laura Pyle; Gregory P Forlenza; Laurel Messer; R Paul Wadwa; Daniel J DeSalvo; Sydney L Payne; Sarah Hanes; Paula Clinton; David M Maahs; Bruce Buckingham Journal: Diabetes Technol Ther Date: 2016-05-26 Impact factor: 6.118
Authors: Peter G Jacobs; Nichole S Tyler; Scott M Vanderwerf; Clara Mosquera-Lopez; Thomas Seidl; Robert Cargill; Deborah Branigan; Katrina Ramsey; Kristin Morris; Sheila Benware; W Kenneth Ward; Jessica R Castle Journal: Biosens Bioelectron Date: 2020-04-29 Impact factor: 12.545