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.

  Lay Summary of Results:

  e are pleased to let you know that the study is now complete. Below is a simple summary of what we found.
  What was the study about?
  The study compared two ways of managing Type 1 diabetes:
  • The Omnipod 5 System (an automated insulin delivery system)
  • Multiple daily injections (MDI) of Insulin
  We wanted to understand which approach works best to control blood sugar levels safely.
  At the start:
  • Everyone used their usual injections and sensor for 2 weeks
  • Then participants were randomly placed into one of two groups:
  o Omnipod 5 System
  o Usual injections (MDI)
  This first part lasted 13 weeks.
  After that:
  • Everyone used the Omnipod 5 System for another 13 weeks
  Who took part?
  • 188 children and adults (aged 4 to 70 years)
  • Participants from the UK, France, and Belgium

  What did the study find?
  After the first 13 weeks
  People using the Omnipod 5 System had better blood glucose (sugar) control than those on MDI.
  • Average blood glucose control (HbA1c):
  o Omnipod 5: improved from 8.1% to 7.2%
  o MDI: stayed about the same (8.1% to 8.0%)
  • Time in range (healthy blood sugar range):
  o Omnipod 5: increased from 39% to 65%
  o MDI: small change (41% to 43%)
  • Time blood glucose was low (<70 mg/dL):
  o Similar between the two groups (no increase with Omnipod 5)
  o This means people using Omnipod 5 had better control without more low blood glucose events.
  Participants on Omnipod 5 also reported positive or similar experiences compared with MDI via questionnaires about their quality of life related to diabetes.

  Was it safe?
  Yes. There were no safety concerns during this period.
  • No cases of:
  o Severe hypoglycaemia (low blood glucose)
  o Diabetic ketoacidosis (a serious complication)
  • Two serious health events occurred, but were not related to the study device
  • No deaths were reported
  What happened next? (Second 13 weeks)
  All participants then used the Omnipod 5 System.
  Results:
  • People who continued using Omnipod 5:
  o Consistent and sustained blood glucose control (HbA1c of 7.2%)
  • People who switched from MDI to Omnipod 5:
  o Showed clear improvements (HbA1c improved from 8.0% to 7.3%)
  • Low blood sugar levels remained similar and well-controlled
  Participants again reported positive experiences with the Omnipod 5 system.
  Safety during this period
  • No new safety concerns overall
  • No deaths or unexpected problems were reported
  • Some health events occurred, but most were not related to the device
  • No deaths were reported

  What does this mean?
  The study showed that the Omnipod 5 System:
  • Provides significant and sustained improvements in blood glucose control and other glycaemic outcomes over time
  • Is safe to use for both children and adults

  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05923827%253Fterm%253DNCT05923827%2526viewType%253DCard%2526rank%253D1%2526tab%253Dresults%2FNBTI%2FLGLGAQ%2FAQ%2Fdd7c0b89-7541-4567-8360-42a58c3c3668%2F1%2FlKGC3yRaOz&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C7820dd6e33e443479a0808ded69e88f4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639184173544610005%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ppKsYxWQsHYOy60H7bSDpbPcswIMAQ9cYa8NyNR3%2FZE%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: The 13wk RCT results were presented at ATTD in March 2024 and published in Lancet D&E (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flandia%2Farticle%2FPIIS2213-8587&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C7820dd6e33e443479a0808ded69e88f4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639184173544644796%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=wjp1OrsNcgppbnPR2OA2vk0obvwTrAnYLlLpip9PjXI%3D&reserved=0(25)00364-X/abstract). The 26wk results were also presented at EASD in September 2025.
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: Although the initial favourable opinion did not require formally sharing the results with the participants, the Investigators will be sharing the results with their participants anyway using the same lay summary of results that is being entered in this webform over the next couple of weeks.
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: The results will be communicated by the Investigators with each participant via email/post. Information provided include links to publicly available information on clinicaltrials.gov https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05923827%253Fterm%253DNCT05923827%2FNBTI%2FLGLGAQ%2FAQ%2Fdd7c0b89-7541-4567-8360-42a58c3c3668%2F2%2FH5eSjmTywo&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C7820dd6e33e443479a0808ded69e88f4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639184173544665281%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=lTiUsqow2lXbzIYoISpST0aE2ri80UTPYb7YobT1xwE%3D&reserved=0
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: Not applicable. No tissue samples were collected as part of the study
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• 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