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

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)

NCT05923827•Insulet Corporation

View on ClinicalTrials.gov

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.

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. Participants in Belgium and France will be given the option to continue using the Omnipod 5 System for up to an additional 9-months.

Eligibility

Age

4 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age at time of consent 4-70 years.
•2. Clinical diagnosis of type 1 diabetes for at least 1 year prior to screening. Diagnosis is based on investigator's clinical judgement.
•3. 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.
•4. 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.
•5. Must be willing to use the FreeStyle Libre 2 Sensor for the duration of the study.
•6. HbA1c 7.5-11% (58-97mmol/mol) by point-of-care taken at screening visit
•7. 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.
•8. 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.
•9. Participants or parent/guardian able to read and understand Dutch, English or French.
•10. Willing to wear the system continuously throughout the study
+3 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•3. History of diabetic ketoacidosis (DKA) in the past 6 months.
•4. 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.
•5. Using any form of pump therapy, including non-automated and automated insulin delivery (AID) systems, within 6 months prior to screening.
•6. 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.
•7. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement.
•8. 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.
•9. 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).
•10. 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.
+5 more criteria

Locations (19)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Centre Hospitalier Universitaire Côte de Nacre

Caen, France

CHU Grenoble Aples

Grenoble, France

Hospices Civils de Lyon

Lyon, France

Hôpitaux Universitaires de Marseille Timone

Marseille, France

CHU de Nancy

Nancy, France

Hôpitaux Pédiatriques de Nice CHU-Lenval,

Nice, France

Centre Hospitalier Universitaire Carémeau de Nîmes

Nîmes, France

Hôpital Necker

Paris, France

Key Dates

Start Date

September 11, 2023

Primary Completion Date

August 2, 2024

Completion Date

August 8, 2025

Last Updated

October 26, 2024

Enrollment

200

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 1

Interventions

Omnipod 5 System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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