Omnipod 5 w/ Libre 2 vs MDI for Type 1 Diabetes in children and adults

• Research type

  Research Study

• Full title

  RAndomized Controlled Trial to Demonstrate the Efficacy of the Omnipod® 5 with FreeStyle Libre 2 Compared to Multiple Daily Injections for TreAtmeNT of Type 1 Diabetes (RADIANT)

• IRAS ID

  321508

• Contact name

  Abigail Murphy

• Contact email

  amurphy2@insulet.com

• Sponsor organisation

  Insulet Corporation

• Clinicaltrials.gov Identifier

  NCT05923827

• Duration of Study in the UK

  0 years, 9 months, 6 days

• Research summary

  The treatment of Type 1 Diabetes has significantly advanced over the past 20 years. Patients are no longer limited to multiple daily injections (MDI) or non-automated insulin pump therapies. Insulet Corporation (Sponsor), wants to test the Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) with Freestyle Libre 2 sensor to find out if the Omnipod 5 with this sensor is better at keeping blood sugar in range compared to multiple daily insulin injections, also called MDI, in participants with type 1 diabetes.
  Several doctors at up to 20 sites in the UK, France and Belgium will be collecting study data from up to 200 enrolled participants, comprised of 120 children and 80 adults with type 1 diabetes who are currently on MDI and using the FreeStyle Libre 2 sensor.
  Eligible participants will be assigned randomly (2:1 ratio in favor of the Intervention group) to:

  • Intervention group: Omnipod 5 System with FreeStyle Libre 2 Sensor or
  • Control group: MDI with FreeStyle Libre 2 Sensor

  Both groups will participate for a total of 28 weeks. During the first 2 weeks, sensor data will be collected followed by a 13-week randomized period. Participants in the Control group will stay on MDI therapy with their glucose sensor, while the Intervention group will use the Omnipod 5 System. At the end of the 13-week randomized period, the Control group will also begin use of the Omnipod 5 System for 13 weeks. Both groups will use the system from weeks 14-26 with periodic follow up with the study team.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  23/YH/0026

• Date of REC Opinion

  31 Mar 2023

• REC opinion

  Further Information Favourable Opinion