Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-07 @ 8:14 PM
Study NCT ID:
NCT03216460
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2017-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulet Artificial Pancreas Free-Living IDE3
Sponsor:
Insulet Corporation
Organization:
Study Overview
Official Title:
Evaluating Glucose Control in Patients With Type 1 Diabetes Under Free-living Conditions With the Insulet Automated Glucose Control System: IDE3
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
Detailed Description:
The study schedule will consist of a standard therapy data collection week followed by a hybrid closed-loop phase.
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
The hybrid closed-loop phase will begin prior to lunch on Study Day 1.
During the hybrid closed-loop phase, subjects will participate in specific setpoint challenges, meal challenges, and exercise.
Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study Day 5. Subjects will be asked to complete a post-study questionnaire regarding their experience with the system. Subjects will be discharged home when stable and all discharge criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid closed-loop before they leave the study site.
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
The hybrid closed-loop phase will begin prior to lunch on Study Day 1.
During the hybrid closed-loop phase, subjects will participate in specific setpoint challenges, meal challenges, and exercise.
Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study Day 5. Subjects will be asked to complete a post-study questionnaire regarding their experience with the system. Subjects will be discharged home when stable and all discharge criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid closed-loop before they leave the study site.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: