Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181721
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-11-14
Brief Title:
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
Sponsor:
Insulet Corporation
Organization:
Insulet Corporation
Study Overview
Official Title:
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Evolution
Brief Summary:
To assess the safety and effectiveness of a next-generation automated insulin delivery algorithm in participants aged 16 years with type 1 or type 2 diabetes
Detailed Description:
This study is a single-arm observational clinical study that will enroll a maximum of 72 participants
Participants between the ages of 16 years with type 1 or type 2 diabetes currently using an insulin pump or receiving basal and bolus multiple daily injections MDI with an A1C between 75-110 at screening will be recruited for the study
Two participant groups will be recruited and will participate in up to 4 Phases
Group A Participants with type 1 diabetes will participate in Phase 1 Phase 2 Phase 3 and Phase 4
Group B Participants with type 2 diabetes will participate in Phase 1 and Phase 4
Phase 1 Group A and B will include
14 days of Standard Therapy while using a blinded Dexcom G6 CGM in an outpatient setting
Phase 2 Group A only will include
48 hours of using build 1bx of the Omnipod 5 System in Manual Mode in an outpatient setting
Phase 3 Group A only will include
3 day2 night supervised hotel stay using build 1bx of the Omnipod 5 System in Automated Mode while also participating in meal and exercise challenges at a defined target glucose setting of 56 mmolL 100 mgdL During the first 24 hours participants will be instructed to not bolus for meals For the following 24 hours participants will be instructed to bolus for meals At least 2 meals each day must contain at least 60 grams of carbohydrates In addition each day participants will take part in 45 minutes of exercise
Phase 4 Group A and B will include
A total of 6 weeks using the Omnipod 5 System in Automated Mode in an outpatient setting at a defined target glucose setting of 56 mmolL 100 mgdL During weeks 1-3 participants will be instructed to bolus for meals During weeks 4-6 participants will be instructed to not bolus for meals
After completion of a minimum of 10 participants for Group A Phase 3 the data will be analysed and must meet prespecified criteria for Group A to proceed to Phase 4 and Group B to proceed to Phase 1 followed by Phase 4
If the prespecified criteria are not met software changes will be made and Group A Phase 3 may be repeated either with the same participants or additional participants that meet the study criteria Iterations of Group A Phase 3 may continue until prespecified criteria are met
Participants between the ages of 16 years with type 1 or type 2 diabetes currently using an insulin pump or receiving basal and bolus multiple daily injections MDI with an A1C between 75-110 at screening will be recruited for the study
Two participant groups will be recruited and will participate in up to 4 Phases
Group A Participants with type 1 diabetes will participate in Phase 1 Phase 2 Phase 3 and Phase 4
Group B Participants with type 2 diabetes will participate in Phase 1 and Phase 4
Phase 1 Group A and B will include
14 days of Standard Therapy while using a blinded Dexcom G6 CGM in an outpatient setting
Phase 2 Group A only will include
48 hours of using build 1bx of the Omnipod 5 System in Manual Mode in an outpatient setting
Phase 3 Group A only will include
3 day2 night supervised hotel stay using build 1bx of the Omnipod 5 System in Automated Mode while also participating in meal and exercise challenges at a defined target glucose setting of 56 mmolL 100 mgdL During the first 24 hours participants will be instructed to not bolus for meals For the following 24 hours participants will be instructed to bolus for meals At least 2 meals each day must contain at least 60 grams of carbohydrates In addition each day participants will take part in 45 minutes of exercise
Phase 4 Group A and B will include
A total of 6 weeks using the Omnipod 5 System in Automated Mode in an outpatient setting at a defined target glucose setting of 56 mmolL 100 mgdL During weeks 1-3 participants will be instructed to bolus for meals During weeks 4-6 participants will be instructed to not bolus for meals
After completion of a minimum of 10 participants for Group A Phase 3 the data will be analysed and must meet prespecified criteria for Group A to proceed to Phase 4 and Group B to proceed to Phase 1 followed by Phase 4
If the prespecified criteria are not met software changes will be made and Group A Phase 3 may be repeated either with the same participants or additional participants that meet the study criteria Iterations of Group A Phase 3 may continue until prespecified criteria are met
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None