Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616779
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
DigiDiab Evaluation Domiciliary Nursing Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Single-centre Non-interventional Study of the CE-marked Medical Device GlucoTab According to Intended Use Without Additional Invasive and Stressful Measures
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 a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin andor other glucose-lowering drugs or of patients only requiring glucose monitoring
It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes which will be used in this study
It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes which will be used in this study
Detailed Description:
GlucoTab The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes
In this study only the GlucoTab algorithm supported basal therapy will be used which is intended for patients with Type 2 diabetes in domiciliary nursing care requiring insulin therapy
GlucoTab has a CE certificate will be used according to its intended purpose and no additional burdensome or invasive interventions are planned
In this study only the GlucoTab algorithm supported basal therapy will be used which is intended for patients with Type 2 diabetes in domiciliary nursing care requiring insulin therapy
GlucoTab has a CE certificate will be used according to its intended purpose and no additional burdensome or invasive interventions are planned
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