Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605872
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
DigiDiab Pilot Impact Study Hospital
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Multicentre Prospective Non-interventional Study of the CE-marked Medical Device GlucoTab According to Intended Use Without Additional Invasive and Stressful Measures With a Matched Retrospective Control Group
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GlucoTab is an innovative workflow and decision support tool for standardised diabetes management by healthcare professionals which provides automated and personalised dosage recommendations for different insulin therapy regimens
Detailed Description:
GlucoTab has already been tested in several clinical trials in Austria and has consecutively obtained the CE-mark that is valid throughout European countries
The current study aims to further develop implement and evaluate GlucoTab in different European pilot regions For this reason GlucoTab will be translated in different languages and tested in Sweden Denmark and Spain
The current study aims to further develop implement and evaluate GlucoTab in different European pilot regions For this reason GlucoTab will be translated in different languages and tested in Sweden Denmark and Spain
Study Oversight
Has Oversight DMC:
None
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?:
None