Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627517
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Automated Insulin Delivery for Multiple Daily Injectors AID4MDI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
AID4MDI
Brief Summary:
The purpose of this research is to evaluate the effect of a wearable insulin pump on blood sugar levels during sleep The study device works with continuous glucose monitors CGM to calculate and deliver rapid-acting insulin doses during sleep The study device does not replace long-acting correction or mealtime insulin The study will involve applying the study device before bed for a period of 13 weeks The overall study length is approximately 17 weeks
The study aims to evaluate whether the study device is safe and if it lowers blood sugar levels in people who have consistently high blood sugar during sleep and at wake
The study aims to evaluate whether the study device is safe and if it lowers blood sugar levels in people who have consistently high blood sugar during sleep and at wake
Detailed Description:
None
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