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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Omnipod 5 System

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trang Ly, MBBS; Phone Number: (978) 600-7000; Email: APClinical@insulet.com
• Study Contact Backup: Name: Bonnie Dumais, RN; Phone Number: (978) 600-7000; Email: APClinical@insulet.com

Study Locations

• Belgium
  • Brussels, Belgium
    • Not yet recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Philippe Lysy, Prof
  • Leuven, Belgium
    • Recruiting
    • Universitaire Ziekenhuizen Leuven
    • Principal Investigator: Pieter Gillard, Pr
• France
  • Caen, France
    • Recruiting
    • Centre Hospitalier Universitaire Côte de Nacre
    • Principal Investigator: Michael Joubert, Pr
  • Grenoble, France
    • Recruiting
    • CHU Grenoble Aples
    • Principal Investigator: Sandrine Lablanche, Pr
  • Lyon, France
    • Recruiting
    • Hospices Civils de Lyon
    • Principal Investigator: Marc Nicolino, Pr
  • Marseille, France
    • Not yet recruiting
    • Hôpitaux Universitaires de Marseille Timone
    • Principal Investigator: Rachel Reynaud, Dr
  • Nancy, France
    • Not yet recruiting
    • Chu de Nancy
    • Principal Investigator: Bruno Guerci, Dr.
  • Nice, France
    • Not yet recruiting
    • Hôpitaux Pédiatriques de Nice CHU-Lenval,
    • Principal Investigator: Cécile Darnaud, Dr.
  • Nîmes, France
    • Not yet recruiting
    • Centre Hospitalier Universitaire Carémeau de Nîmes
    • Principal Investigator: Randa Salet, Dr.
  • Paris, France
    • Not yet recruiting
    • Hopital Necker
    • Principal Investigator: Jacques Beltrand, Pr
  • Paris, France
    • Not yet recruiting
    • Robert-Debré AP-HP Hospital
    • Principal Investigator: Elise Bismuth, Dr
  • Reims, France
    • Recruiting
    • Centre Hospitalier Universitaire de Reims
    • Principal Investigator: Pierre-François Souchon, Dr.
  • Rennes, France
    • Not yet recruiting
    • CHU Rennes
    • Principal Investigator: Marie-Beatrice Saade, Prof
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Principal Investigator: Hélène Hanaire
• United Kingdom
  • Derby, United Kingdom
    • Recruiting
    • University Hospitals of Derby & Burton
    • Principal Investigator: Emma Wilmot, Dr.
  • Leicester, United Kingdom
    • Recruiting
    • University Hospitals Of Leicester Nhs Trust
    • Principal Investigator: Pratik Choudhary, Pr
  • Manchester, United Kingdom
    • Not yet recruiting
    • North Manchester General Hospital
    • Principal Investigator: Lalantha Leelarathna, Dr
  • Ormskirk, United Kingdom
    • Recruiting
    • Mersey and West Lancashire NHS Teaching Hospitals Trust
    • Principal Investigator: May Ng, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 English or French.
10. Willing to wear the system continuously throughout the study
11. 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.
12. Willing to limit vitamin C supplementation to 2000 mg or less per day.
13. Must be familiar with carbohydrate counting.

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.
11. 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.
12. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned.
13. Participants who have had a pancreas or pancreatic islet transplantation
14. Presence of unstable retinopathy or painful neuropathy, per Investigator's judgement.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor	Device: Omnipod 5 System; 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.
No Intervention: Control Group; Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time in range 70-180 mg/dL	Glucose metric from study provided continuous glucose monitor (CGM)	Comparing intervention group with control group during the 13-week study phase
Percentage of time <54 mg/dL (non-inferior)	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of time >180 mg/dL	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of time >300 mg/dL	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of time <70 mg/dL (non-inferior)	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Change from baseline in HbA1c for participants ≥18 years of age at baseline	Glucose metric from study CGM	Comparing intervention group with control group at the end of the 13-week study phase
Change from baseline in HbA1c for participants <18 years of age at baseline	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of time in range 70-180 mg/dL for participants ≥18 years of age at baseline	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of time in range 70-180 mg/dL for participants <18 years of age at baseline	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Change from baseline in HbA1c in participants with baseline HbA1c ≥8%	Measured at baseline and 13 weeks in both intervention and control groups	Comparing intervention group with control group at the end of the 13-week study phase
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.	Comparing intervention group with control group at the end of the 13-week study phase
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.	Comparing intervention group with control group at the end of the 13-week study phase
Change from baseline in PSQI Duration of Sleep subscale score in caregivers of participants <18 years of age at baseline	Used to measure sleep disturbance and usual sleep habits	Comparing intervention group with control group at the end of the 13-week study phase
Change from baseline in PSQI Subjective Sleep Quality subscale score in caregivers of participants <18 years of age at baseline	Used to measure sleep disturbance and usual sleep habits	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of participants achieving HbA1c <7%	Measured at 13 weeks in both intervention and control groups	Comparing intervention group with control group at the end of the 13-week study phase
Change from baseline in EQ-5D-3L index score	Used to measure quality of life	Comparing intervention group with control group at the end of the 13-week study phase
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	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of time <70 mg/dL	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase
Percentage of time <54 mg/dL	Glucose metric from CGM	Comparing intervention group with control group at the end of the 13-week study phase

Collaborators and Investigators

• Sponsor: Insulet Corporation
• Investigators: Principal Investigator: Emma Wilmot, MD, University Hospitals of Derby & Burton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): April 19, 2024
• Study Completion (Estimated): August 9, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: T1D; Automated Insulin Delivery; Omnipod
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RADIANT OP5-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes