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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Omnipod 5 System
Sponsored by
Insulet Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring T1D, Omnipod, Automated Insulin Delivery

Eligibility Criteria

4 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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. Exclusion Criteria: 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.

Sites / Locations

  • Cliniques Universitaires Saint-Luc
  • Universitaire Ziekenhuizen Leuven
  • Centre Hospitalier Universitaire Côte de Nacre
  • CHU Grenoble Aples
  • Hospices Civils de Lyon
  • Hôpitaux Universitaires de Marseille Timone
  • CHU de Nancy
  • Hôpitaux Pédiatriques de Nice CHU-Lenval,
  • Centre Hospitalier Universitaire Carémeau de Nîmes
  • Hôpital Necker
  • Robert-Debré AP-HP Hospital
  • Centre Hospitalier Universitaire de Reims
  • CHU Rennes
  • CHU Toulouse
  • University Hospitals of Derby & BurtonRecruiting
  • University Hospitals of Leicester NHS TrustRecruiting
  • North Manchester General Hospital
  • Mersey and West Lancashire NHS Teaching Hospitals TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of time in range 70-180 mg/dL
Glucose metric from study provided continuous glucose monitor (CGM)
Percentage of time <54 mg/dL (non-inferior)
Glucose metric from CGM
Percentage of time >180 mg/dL
Glucose metric from CGM
Percentage of time >300 mg/dL
Glucose metric from CGM
Percentage of time <70 mg/dL (non-inferior)
Glucose metric from CGM
Change from baseline in HbA1c for participants ≥18 years of age at baseline
Glucose metric from study CGM
Change from baseline in HbA1c for participants <18 years of age at baseline
Glucose metric from CGM
Percentage of time in range 70-180 mg/dL for participants ≥18 years of age at baseline
Glucose metric from CGM
Percentage of time in range 70-180 mg/dL for participants <18 years of age at baseline
Glucose metric from CGM
Change from baseline in HbA1c in participants with baseline HbA1c ≥8%
Measured at baseline and 13 weeks in both intervention and control groups
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.
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.
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
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
Percentage of participants achieving HbA1c <7%
Measured at 13 weeks in both intervention and control groups
Change from baseline in EQ-5D-3L index score
Used to measure quality of life
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
Percentage of time <70 mg/dL
Glucose metric from CGM
Percentage of time <54 mg/dL
Glucose metric from CGM

Full Information

First Posted
June 20, 2023
Last Updated
September 27, 2023
Sponsor
Insulet Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05923827
Brief Title
Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults
Acronym
RADIANT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
April 19, 2024 (Anticipated)
Study Completion Date
August 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insulet Corporation

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
T1D, Omnipod, Automated Insulin Delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
Intervention Type
Device
Intervention Name(s)
Omnipod 5 System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
The change in HbA1c at 13 weeks from baseline between the Intervention and Control groups.
Time Frame
Comparing intervention group with control group during the 13-week study phase
Secondary Outcome Measure Information:
Title
Percentage of time in range 70-180 mg/dL
Description
Glucose metric from study provided continuous glucose monitor (CGM)
Time Frame
Comparing intervention group with control group during the 13-week study phase
Title
Percentage of time <54 mg/dL (non-inferior)
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of time >180 mg/dL
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of time >300 mg/dL
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of time <70 mg/dL (non-inferior)
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in HbA1c for participants ≥18 years of age at baseline
Description
Glucose metric from study CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in HbA1c for participants <18 years of age at baseline
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of time in range 70-180 mg/dL for participants ≥18 years of age at baseline
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of time in range 70-180 mg/dL for participants <18 years of age at baseline
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in HbA1c in participants with baseline HbA1c ≥8%
Description
Measured at baseline and 13 weeks in both intervention and control groups
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in T1-DDS total score for participants ≥18 years of age at baseline
Description
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.
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in HCS total score for participants ≥18 years of age at baseline
Description
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.
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in PSQI Duration of Sleep subscale score in caregivers of participants <18 years of age at baseline
Description
Used to measure sleep disturbance and usual sleep habits
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in PSQI Subjective Sleep Quality subscale score in caregivers of participants <18 years of age at baseline
Description
Used to measure sleep disturbance and usual sleep habits
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of participants achieving HbA1c <7%
Description
Measured at 13 weeks in both intervention and control groups
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in EQ-5D-3L index score
Description
Used to measure quality of life
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Change from baseline in total daily insulin (TDI) (units/kg) for participants ≥18 years of age
Description
Measure of insulin requirements measured at 13 weeks in both intervention and control groups
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of time <70 mg/dL
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase
Title
Percentage of time <54 mg/dL
Description
Glucose metric from CGM
Time Frame
Comparing intervention group with control group at the end of the 13-week study phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trang Ly, MBBS
Phone
(978) 600-7000
Email
APClinical@insulet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie Dumais, RN
Phone
(978) 600-7000
Email
APClinical@insulet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Wilmot, MD
Organizational Affiliation
University Hospitals of Derby & Burton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Lysy, Prof
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter Gillard, Pr
Facility Name
Centre Hospitalier Universitaire Côte de Nacre
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Joubert, Pr
Facility Name
CHU Grenoble Aples
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine Lablanche, Pr
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Nicolino, Pr
Facility Name
Hôpitaux Universitaires de Marseille Timone
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Reynaud, Dr
Facility Name
CHU de Nancy
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Guerci, Dr.
Facility Name
Hôpitaux Pédiatriques de Nice CHU-Lenval,
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Darnaud, Dr.
Facility Name
Centre Hospitalier Universitaire Carémeau de Nîmes
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randa Salet, Dr.
Facility Name
Hôpital Necker
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Beltrand, Pr
Facility Name
Robert-Debré AP-HP Hospital
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Bismuth, Dr
Facility Name
Centre Hospitalier Universitaire de Reims
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-François Souchon, Dr.
Facility Name
CHU Rennes
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Beatrice Saade, Prof
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Hanaire
Facility Name
University Hospitals of Derby & Burton
City
Derby
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Wilmot, Dr.
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pratik Choudhary, Pr
Facility Name
North Manchester General Hospital
City
Manchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lalantha Leelarathna, Dr
Facility Name
Mersey and West Lancashire NHS Teaching Hospitals Trust
City
Ormskirk
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
May Ng, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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