Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System

NCT07579702 | Not Yet Recruiting FDA Device

• 1 other identifier: STRIVE 2
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

Conditions

Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus

Keywords

Omnipod; Automated Insulin Delivery; T2D; T1D; Type 2 Diabetes; Type 1 Diabetes; AID

Outcome Measures

Primary Outcomes (8)

• Time in Range 70-180 mg/dL

  Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5

  13 weeks

• Time <54 mg/dL

  Change in CGM percent time \<54 mg/dL compared between Omnipod 6 and Omnipod 5

  13 weeks

• Time <70 mg/dL

  Change in CGM percent time \<70 mg/dL compared between Omnipod 6 and Omnipod 5

  13 weeks

• Time >180 mg/dL

  Change in CGM percent time \>180 mg/dL compared between Omnipod 6 and Omnipod 5

  13 weeks

• Time in Range 70-140 mg/dL

  Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5

  13 weeks

• HbA1c

  Change in HbA1c (%) between Omnipod 6 and Omnipod 5

  13 weeks

• Mean sensor glucose

  Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5

  13 weeks

• Time >250 mg/dL

  Change in CGM percent time \>250 mg/dL compared between Omnipod 6 and Omnipod 5

  13 weeks

Secondary Outcomes (23)

• Total boluses per day

  13 weeks

• Total daily insulin per kg and total insulin delivered via automation

  13 weeks

• Percentage of time in automated mode

  13 weeks

• Percentage with HbA1c <7.0% and <7.5%

  13 weeks

• Percentage with >= 70% time in range

  13 weeks

Study Arms (2)

Omnipod 5 System

ACTIVE COMPARATOR

Device: Omnipod 5 System

Omnipod 6 System

EXPERIMENTAL

Device: Omnipod 6 System

Interventions

Omnipod 5 System DEVICE

The Omnipod 5 System with the study CGM

Omnipod 5 System

Omnipod 6 System DEVICE

The Omnipod 6 System with the study CGM

Omnipod 6 System

Eligibility Criteria

• Age: 14 Years - 75 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 14-75 years (inclusive)
• Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
• Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
• HbA1c ≥ 7.5%
• Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
• Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user
• Currently using a continuous glucose monitor
• Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.
• Participant agrees to provide their own insulin for the duration of the study
• Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
• Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
• If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
• Willing to wear the system continuously throughout the study
• Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged \< 18 years per local regulatory requirements
• Able to read and understand English and operate the study device in English

You may not qualify if:

• Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
• Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
• Any planned surgery during the study which could be considered major in the judgment of the investigator
• 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 mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
• History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
• Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
• Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
• Use of hydroxyurea
• Plans to receive blood transfusion over the course of the study
• Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
• Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
• Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
• Pregnant or lactating, or 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 intends to participate in any other 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

Sponsors & Collaborators

• Insulet Corporation: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; 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

Central Study Contacts

Trang Ly, MBBS, PhD

CONTACT

978-600-7000; APClinical@insulet.com

Bonnie Dumais, RN

CONTACT

APClinical@insulet.com

Study Design

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

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 12, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share