Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Ch... | NCT05923827

Status Module

Description Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

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

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)

Eligibility Module

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 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.

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.

Name	Affiliation	Role
Emma Wilmot, MD	University Hospitals of Derby & Burton NHS Foundation Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint-Luc		Brussels			Belgium
Universitaire Ziekenhuizen Leuven

PubMed Identifier	Type	Citation	Retractions
41747751	Derived	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 16, 2025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline

- ParticipantsOG000123
- ParticipantsOG00163

Title	Measurements
	OG0008.13± 0.70

Secondary

Percentage of Time in Range 70-180 mg/dL

Glucose metric from study provided continuous glucose monitor (CGM)

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

Percentage of Time >180 mg/dL

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

Percentage of Time >300 mg/dL

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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

Glucose metric from study CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Error

Percentage of HbA1C

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Error

Percentage of HbA1C

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Error

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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

Glucose metric from CGM

Posted

Mean

Standard Error

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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

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

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percent of change

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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.

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Scores on a scale

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants

Secondary

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.

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Scores on a scale

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants

Secondary

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.

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Score on a scale

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts

Secondary

Percentage of Time <70 mg/dL

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percent of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving HbA1c <7%

Participants achieving HbA1C < 7% [N]

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Secondary

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.

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Score on a scale

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants

Secondary

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

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Change from Baseline (units/kg)

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants

Secondary

Percentage of Time <54 mg/dL

Glucose metric from CGM

Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Posted

Mean

Standard Deviation

Percentage of time

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

ID	Title	Description
OG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
OG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Other	Vascular disorders		Systematic Assessment	This event was diagnosed as Kawasaki's Disease.	EG0001 events1 affected125 at risk EG0010 events0 affected63 at risk
Other	Cardiac disorders		Systematic Assessment	This event was diagnosed as acute coronary syndrome.	EG0001 events1 affected125 at risk EG0010 events0 affected63 at risk

Term	Organ System	Assessment Type	Statistical Information
Other	Investigations	Systematic Assessment	EG00021 events17 affected125 at risk EG0013 events3 affected63 at risk
Hyperglycemia	Endocrine disorders	Systematic Assessment	EG0008 events5 affected125 at risk EG0010 events0 affected63 at risk
Prolonged Hyperglycemia	Endocrine disorders	Systematic Assessment	EG0008 events8 affected125 at risk EG0010 events0 affected63 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.
BG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intervention Group	Omnipod 5 System with FreeStyle Libre 2 continuous glucose monitor 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.	0	125	2	125	26	125
EG001	Control Group	Multiple daily injections of insulin with FreeStyle Libre 2 continuous glucose monitor	0	63	0	63	3	63