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Omnipod Horizon Hybrid Closed-Loop Pivotal Study Seeking Participants

By Frida Velcani

A clinical trial testing the safety and efficacy of Insulet’s Omnipod Horizon hybrid closed loop system is now fully enrolled. Data will support FDA approval, expected in the second half of 2020

Clinical Trials Identifier: NCT04196140 

Trial name: Evaluating the Safety and Effectiveness of the Omnipod Horizon Automated Glucose Control System in Patients with Type 1 Diabetes

Update: Trial now fully enrolled

Diabetes type: Type 1

What the trial is testing: The Omnipod Horizon is an automated insulin delivery (AID) system that uses continuous glucose monitor (CGM) readings to automatically adjust basal insulin delivery. Omnipod’s three-day wear patch pump will communicate with Dexcom’s G6 CGM while allowing users to control the system directly from their smartphone. For now, only select Android phones offer a compatible app, but efforts to make an app available to iPhone users are underway. Because the Omnipod pump will store the algorithm and communicate directly with Dexcom G6, the system will work even when the smartphone/pump controller is not nearby. Researchers hope to test the safety and effectiveness of Insulet’s Omnipod Horizon system by comparing it to CGM and insulin delivery via participants’ current pumps or daily injections.

What the trial is measuring:  In the first 14 days of the study, participants will follow their standard insulin regimen at home, while using a CGM. Participants will then spend the following 13 weeks using the Horizon hybrid closed-loop system. CGM and pump data will be collected throughout the entire study.

Researchers will examine participants’ A1cC levels, time spent in-range (70-180 mg/dl), and more. They will also record instances of severe hypoglycemia and diabetic ketoacidosis (DKA).

A random group of participants on the hybrid closed-loop system will be asked to eat specific meals and participate in exercise challenges for five days of the study.

Why is this new/important? 

As a pivotal trial, the results from this study will be submitted to the FDA to support approval of the Omnipod Horizon hybrid closed loop system, which aims to launch in the second half of 2020.The Omnipod Horizon is the first AID system that can be controlled with a smartphone.

Automated insulin delivery can help people with diabetes reduce hypoglycemia (low blood sugar), improve time in range, and reduce hyperglycemia (high blood sugar) – especially overnight. This study will help understand the benefits of the hybrid closed-loop system over traditional daily insulin injections or pump therapy with CGM.

Trial length: 15 weeks

Trial locations: Anyone in the United States can participate. There are multiple trial locations.

Are you interested? The trial is now fully enrolled with participants meeting eligibility criteria that includes:

  • Age: 6-70 years

  • Diagnosed with type 1 diabetes for at least six months

  • Willing to use only Humalog, Novolog, Admelog or Apidra insulins during the study

  • Willing to travel to participate in meal and exercise challenges during five days of the hybrid closed-loop phase

  • Willing to wear the system continuously throughout the study

  • Click here for more eligibility requirements.

For more information: contact Trang Ly at (978) 600-7000 or Bonnie Dumais at (978) 600-7708, or email APClinical@insulet.com.

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