Trials / Completed
CompletedNCT01773668
Feasibility Study - Integrated Sensor and Infusion Set. Trial III
FEASIBILITY STUDY TO ASSESS PERFORMANCE OF THE INTEGRATED SENSOR AND INFUSION SET. WITH HIGH INSULIN NEED USERS (TRIAL III)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Medtronic Diabetes R&D Denmark · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
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. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Integrated sensor and infusion set. |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2013-01-23
- Last updated
- 2013-02-05
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01773668. Inclusion in this directory is not an endorsement.