NCT04617795

Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes

Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Omnipod 5 Automated Insulin Delivery System	The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.

Timeline

• Start date: 2020-11-23
• Primary completion: 2022-03-06
• Completion: 2022-03-06
• First posted: 2020-11-05
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study