Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-03-09 @ 1:58 AM
Study NCT ID:
NCT02614768
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2015-11-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions
Status:
COMPLETED
Status Verified Date:
2023-05
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 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.
Study Oversight
Has Oversight DMC:
False
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?: