Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT01770561

Feasibility Study of an Integrated Sensor and Infusion Set

Diabetes Type 1 Clinical Trial

Official title:
Feasibility Study to Assess Performance of an Integrated Sensor and Infusion Set. TRIAL II

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01770561
Study type Interventional
Source Medtronic Diabetes R&D Denmark
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date October 2012
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02546401 - Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump Phase 3
Enrolling by invitation NCT06207838 - Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump N/A
Withdrawn NCT02057497 - An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms N/A
Active, not recruiting NCT05088616 - Native American Diabetes Project N/A
Withdrawn NCT01501032 - Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes Phase 1
Completed NCT00417131 - Imaging of Islet Transplantation With PET and MRT N/A
Completed NCT03538106 - Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
Completed NCT01565824 - Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web) N/A
Recruiting NCT04257877 - Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)
Withdrawn NCT01322321 - ACZ885 in Type 1 Diabetes Mellitus Phase 2
Active, not recruiting NCT04794283 - Antenatal Hand Milking for Pregnant Women With Diabetes'
Completed NCT03842683 - CGM Precision and Glycaemic Variability
Suspended NCT04874532 - A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia N/A
Terminated NCT00925977 - Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents N/A
Completed NCT02066350 - Cardiovascular Risk Factors After Single Pancreas Transplantation N/A
Completed NCT02137174 - Home and School Visits Intervention for Children With DM TYPE 1 Phase 2/Phase 3
Completed NCT06365255 - National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes
Completed NCT03433677 - A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes Phase 3
Completed NCT04587297 - Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy
Completed NCT02490124 - The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans N/A