Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-05 @ 6:30 AM
Study NCT ID:
NCT04617795
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2020-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Sponsor:
Insulet Corporation
Organization:
Study Overview
Official Title:
Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2025-04
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:
None
Brief Summary:
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive.
Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use.
Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use.
Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use.
Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use.
Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
Detailed Description:
Basal-Bolus - Group A (N=12)
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 6-month optional extension using Automated Mode
Basal - Group B (N=12)
* 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 6-month optional extension using Automated Mode
* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus
* 6-month optional extension using Automated Mode
Basal - Group B (N=12)
* 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by:
* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by:
* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:
* If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR
* If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus
* 6-month optional extension using Automated Mode
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?: