Trials / Completed
CompletedNCT02614768
Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Medical University of Graz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess accuracy and reliability of the SPIDIMAN continuous glucose monitoring (CGM) sensor system with regard to values as measured by Super GL and compare these results with similar evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor and the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.
Detailed description
The study is a single-center open-label study in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) therapy. The study will include a total of 12 subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Glucose Sensor | The investigational intervention is CGM monitoring using four different CGM systems. Three of the four CGM devices which are used will be CGM systems which have received conformité européenne (CE) certification (Dexcom G4 Platinum, Medtronic MiniMed 640G system, Abbott FreeStyle Libre Flash). The SPIDIMAN sensor will be used for the first time in human subjects, does not yet have received CE certification and will be given an identifying label in addition to being labelled "for investigative use only". |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2015-08-01
- Completion
- 2015-09-01
- First posted
- 2015-11-25
- Last updated
- 2023-05-06
- Results posted
- 2023-05-06
Source: ClinicalTrials.gov record NCT02614768. Inclusion in this directory is not an endorsement.