NCT06181721

Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 7.5-11.0% 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 1b.x of the Omnipod 5 System in Manual Mode in an outpatient setting Phase 3 (Group A only) will include: • 3 day/2 night supervised hotel stay using build 1b.x of the Omnipod 5 System in Automated Mode while also participating in meal and exercise challenges at a defined target glucose setting of 5.6 mmol/L (100 mg/dL). 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 5.6 mmol/L (100 mg/dL). 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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Omnipod 5 Automated Glucose Control System	The Omnipod 5 Automated Glucose Control System will provide automated insulin delivery

Timeline

• Start date: 2023-09-05
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2023-12-26
• Last updated: 2024-04-02

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated device study