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Diabetes Mellitus, Type 1RADIANTNCT05923827

Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults

A study testing Omnipod 5 System in people with Diabetes Mellitus, Type 1, run by Insulet Corporation at 19 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1 diabetes. Read more about this study

Who is it for?
Ages 4 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Omnipod 5 System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
19 sitesin 3 countries
Study dates
11 Sep 2023to 12 Feb 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age at time of consent 4-70 years.
  • Clinical diagnosis of type 1 diabetes for at least 1 year prior to screening. Diagnosis is based on investigator's clinical judgement.
  • On MDI therapy (≥ 3 insulin injections per day and/or a basal/bolus regimen) for ≥ 3 months prior to screening. Have used insulin for at least 1 year prior to screening.
  • Have used the FreeStyle Libre 2 Sensor for ≥ 3 months with a daily average number of scans ≥ 4 and with sensor readings > 70% of time over the previous month prior to screening. Sensor usage is determined from the download summary report for 30 days preceding screening visit.
  • Must be willing to use the FreeStyle Libre 2 Sensor for the duration of the study.
  • HbA1c 7.5-11% (58-97mmol/mol) by point-of-care taken at screening visit
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  • Deemed appropriate for pump therapy per investigator's assessment with respect to previous history of severe hypoglycemic and hyperglycemic events, other comorbidities, and capability of operating study devices and adhering to the protocol.
  • Willing to use and obtain U-100 insulin: either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)) as the primary insulin treatment while using the Omnipod 5 System.
  • Participants or parent/guardian able to read and understand Dutch, English or French.
  • Willing to wear the system continuously throughout the study
  • Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent participants aged < 18 years per Country requirements.
  • Willing to limit vitamin C supplementation to 2000 mg or less per day.
  • Must be familiar with carbohydrate counting.

Who cannot join

  • Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk.
  • History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
  • History of diabetic ketoacidosis (DKA) in the past 6 months.
  • Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1c.
  • Using any form of pump therapy, including non-automated and automated insulin delivery (AID) systems, within 6 months prior to screening.
  • Currently on systemic steroids or intends to receive systemic steroid treatment in the next 6 months, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed. If previously on oral steroids, last intake should be ≥14 days prior to screening visit.
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  • Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement.
  • Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the baseline visit and during the 6-month study. Participants taking metformin should remain on a steady dose during study participation.
  • Pregnant or lactating (lactating women are only excluded in France), or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).
  • Participation in another clinical study using an investigational drug or device within 30-days or 5 half-lives (whichever is longer) prior to screening, or intends to participate in any other drug or device study during this study period.
  • Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.
  • Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned.
  • Participants who have had a pancreas or pancreatic islet transplantation
  • Presence of unstable retinopathy or painful neuropathy, per Investigator's judgement.
  • Adult participants or parents/guardians with hearing and/or vision impairment that would interfere with recognition of all functions of the Omnipod 5 System, including alerts, alarms, and reminders.

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

France12 sites

  • Centre Hospitalier Universitaire Côte de Nacre

    Caen

  • CHU Grenoble Aples

    Grenoble

  • Hospices Civils de Lyon

    Lyon

  • Hôpitaux Universitaires de Marseille Timone

    Marseille

  • CHU de Nancy

    Nancy

  • Hôpitaux Pédiatriques de Nice CHU-Lenval,

    Nice

  • Centre Hospitalier Universitaire Carémeau de Nîmes

    Nîmes

  • Hôpital Necker

    Paris

  • Robert-Debré AP-HP Hospital

    Paris

  • Centre Hospitalier Universitaire de Reims

    Reims

  • CHU Rennes

    Rennes

  • CHU Toulouse

    Toulouse

Other trials in France

United Kingdom5 sites

  • University Hospitals of Derby & Burton

    Derby

  • University Hospitals of Leicester NHS Trust

    Leicester

  • Manchester University NHS Foundation Trust

    Manchester

  • Mersey and West Lancashire NHS Teaching Hospitals Trust

    Ormskirk

  • Oxford Health NHS Foundation Trust

    Oxford

Other trials in United Kingdom

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • Universitaire Ziekenhuizen Leuven

    Leuven

Other trials in Belgium

About this study

Official title: Randomized Controlled Trial to Demonstrate the Efficacy of the Omnipod® 5 System When Compared to Multiple Daily Injections for Treatment of Type 1 Diabetes (RADIANT)

This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1 diabetes.

Read the detailed description

This is a prospective, randomized, parallel-group multicenter trial followed by an extension phase during which both groups use the Omnipod 5 system.

Participants will undergo a two-week standard therapy period utilizing the FreeStyle Libre 2 continuous glucose monitor (CGM) to collect baseline glycemic information.

Participants will then be randomized to the intervention or control groups (2:1).

Both groups will then participate in Period 1 for a total of 26-weeks after the completion of standard therapy period. During the first 13-weeks, participants randomized to the Control group will continue using MDI therapy with their Libre 2 CGM. Participants randomized to the Intervention group will onboard onto the Omnipod 5 System. At the conclusion of the 13-weeks, the Control group will onboard and use the Omnipod 5 System for an additional 13 weeks. Both groups will continue using the Omnipod 5 System for the remainder of the 26-weeks.

Following Period 1, participants in Belgium and France will be given the option to continue using the Omnipod 5 System with the Libre 2 CGM through commercialization.

Being tested
Omnipod 5 System
Keywords
T1D, Omnipod, Automated Insulin Delivery
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omnipod 5 SystemDevice

    The Omnipod 5 system is a tubeless patch pump that receives glucose values and trend data from the glucose sensor every 5 minutes, automatically calculates insulin dose, and sends delivery commands to the Pod for the delivery of insulin.

Study groups in NCT05923827
Study groupRoleWhat they receive
Intervention GroupActive comparatorOmnipod 5 System with FreeStyle Libre 2 continuous glucose monitor
Receives: Device: Omnipod 5 System
Control GroupNo interventionMultiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c (%)

    The change in HbA1c at 13 weeks from baseline between the Intervention and Control groups.

    Measured: Comparing intervention group with control group during the 13-week study phase

Secondary outcomes (18)

  1. Percentage of Time in Range 70-180 mg/dL

    Glucose metric from study provided continuous glucose monitor (CGM)

    Measured: Comparing intervention group with control group during the 13-week study phase

  2. Percentage of Time <54 mg/dL (Non-inferior)

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  3. Percentage of Time >180 mg/dL

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  4. Percentage of Time >300 mg/dL

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  5. Percentage of Time <70 mg/dL (Non-inferior)

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  6. Change From Baseline in HbA1c for Participants ≥18 Years of Age at Baseline

    Glucose metric from study CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  7. Change From Baseline in HbA1c for Participants <18 Years of Age at Baseline

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  8. Percentage of Time in Range 70-180 mg/dL for Participants ≥18 Years of Age at Baseline

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  9. Percentage of Time in Range 70-180 mg/dL for Participants <18 Years of Age at Baseline

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  10. Change From Baseline in HbA1c in Participants With Baseline HbA1c ≥8%

    Measured at baseline and 13 weeks in both intervention and control groups

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  11. Change From Baseline in PSQI Total Score

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale assessing sleep quality over the past month. It produces a 0-21 total score, with higher scores indicating worse sleep quality. Results are reported as scores on a scale.

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  12. Change From Baseline in T1-DDS Total Score for Participants ≥18 Years of Age at Baseline

    A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  13. Change From Baseline in HCS Total Score for Participants ≥18 Years of Age at Baseline

    A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  14. Percentage of Time <70 mg/dL

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  15. Percentage of Participants Achieving HbA1c <7%

    Participants achieving HbA1C < 7% [N]

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  16. Change From Baseline in EQ-5D-3L Index Score

    Change from baseline in the EQ-5D-3L index score, a standardized measure of health-related quality of life. Scores range from -0.594 to 1 (full health), with higher scores indicating better health status.

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  17. Change From Baseline in Total Daily Insulin (TDI) (Units/kg) for Participants ≥18 Years of Age

    Measure of insulin requirements measured at 13 weeks in both intervention and control groups

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

  18. Percentage of Time <54 mg/dL

    Glucose metric from CGM

    Measured: Comparing intervention group with control group at the end of the 13-week study phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start11 Sep 2023
  3. Primary completion16 Aug 2024
  4. Study completion12 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923827
Sponsor's protocol ID
RADIANT OP5-004
Acronym
RADIANT
Status last verified
Apr 2026
First submitted
20 Jun 2023
Last updated
14 Apr 2026
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Wilmot EG, Beltrand J, Guerci B, Berot A, Hanaire H, Bismuth E, Gillard P, Saade MB, Joubert M, Saalet R, Choudhary P, Reynaud R, Leelarathna L, Renard E, Lablanche S, Gouillard-Darnaud C, Ng SM, Lysy P, Daskas N, Perge K, Crabtree TSJ, Ly TT, Nicolino M; RADIANT study group. Tubeless automated insulin delivery versus multiple daily injections in children and adults with type 1 diabetes with elevated HbA1c (RADIANT): a multicentre, international, parallel-group, open-label, randomised, controlled trial. Lancet Diabetes Endocrinol. 2026 Apr;14(4):305-316. doi: 10.1016/S2213-8587(25)00364-X. Epub 2026 Feb 23.

    PubMed 41747751

Questions about this trial

What is this clinical trial studying?

A study testing Omnipod 5 System in people with Diabetes Mellitus, Type 1, run by Insulet Corporation at 19 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (%) (time frame: Comparing intervention group with control group during the 13-week study phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05923827, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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