Omnipod 5 Automated Insulin Delivery System for Diabetes

N/A

Waitlist Available

Research Sponsored by Insulet Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up automated mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for group a and group b

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the Omnipod 5 system, a wearable device that automatically delivers insulin, in people with diabetes who need better blood sugar control. It monitors blood sugar levels and adjusts insulin delivery to maintain target ranges. The Omnipod 5 Automated Insulin Delivery System is a recent advancement in diabetes technology, designed to improve glycemic control and reduce the burden of diabetes management.

Eligible Conditions

Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ automated mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for group a and group b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~automated mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for group a and group b

This trial's timeline: 3 weeks for screening, Varies for treatment, and automated mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for group a and group b for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hyperglycemia

Hypoglycemia

Secondary study objectives

Change in Hemoglobin A1c (HbA1c)

Coefficient of Variation

Mean glucose

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Basal-Bolus (Group A)Experimental Treatment1 Intervention

* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (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

Group II: Basal (Group B)Experimental Treatment1 Intervention

* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by: * 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omnipod 5 Automated Insulin Delivery System

2020

N/A

~30

Do I qualify?Apply below to find out