Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 9:50 AM
Study NCT ID:
NCT01770561
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2012-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of an Integrated Sensor and Infusion Set
Sponsor:
Medtronic Diabetes R&D Denmark
Organization:
Study Overview
Official Title:
Feasibility Study to Assess Performance of an Integrated Sensor and Infusion Set. TRIAL II
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: