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

NCT05923827 | Completed Results FDA Device

• 1 other identifier: RADIANT OP5-004
• Study Type: interventional
• Target: 189
• Locations: 3 countries
• Sites: 19

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

T1D; Omnipod; Automated Insulin Delivery

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (%)

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

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

Secondary Outcomes (18)

• Percentage of Time in Range 70-180 mg/dL

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

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

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

• Percentage of Time >180 mg/dL

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

• Percentage of Time >300 mg/dL

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

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

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

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor

Device: Omnipod 5 System

Control Group

NO INTERVENTION

Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Interventions

Omnipod 5 System DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 4 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (19)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

Centre Hospitalier Universitaire Côte de Nacre

Caen, France

Location

CHU Grenoble Aples

Grenoble, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Hôpitaux Universitaires de Marseille Timone

Marseille, France

Location

CHU de Nancy

Nancy, France

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval,

Nice, France

Location

Centre Hospitalier Universitaire Carémeau de Nîmes

Nîmes, France

Location

Hôpital Necker

Paris, France

Location

Robert-Debré AP-HP Hospital

Paris, France

Location

Centre Hospitalier Universitaire de Reims

Reims, France

Location

CHU Rennes

Rennes, France

Location

CHU Toulouse

Toulouse, France

Location

University Hospitals of Derby & Burton

Derby, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Mersey and West Lancashire NHS Teaching Hospitals Trust

Ormskirk, United Kingdom

Location

Oxford Health NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41747751 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Trang Ly
• Organization: Insulet Corporation

tly@insulet.com

9786007628

Study Officials

• Emma Wilmot, MD

  University Hospitals of Derby & Burton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: September 11, 2023
• Primary Completion: August 16, 2024
• Study Completion: February 12, 2026
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12); BE (2); GB (5)