Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310980
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-04
Brief Title:
Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor
Sponsor:
Giulio Frontino
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Pilot Study in Order to Verify the Effect of the Use of a Smartpen Coordinated With a Continuous Glucose Sensor by a Dedicated App in a Group of Adolescents in Not Good Control Sensor Augmented Smartpen
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
SMARTPEN
Brief Summary:
The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control
Primary endpoint time in range Secondary endpoints other glucometrics Hba1c treatment satisfaction
Primary endpoint time in range Secondary endpoints other glucometrics Hba1c treatment satisfaction
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None