Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System (STRIVE 2)

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Omnipod 5 System; Device: Omnipod 6 System

Detailed Description

Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5.

After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses

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

Contacts and Locations

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

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90022
      • Not yet recruiting
      • University of Southern California
      • Contact: Martha Walker; Phone Number: 323-605-4442; Email: mawalker@usc.edu
      • Principal Investigator: Anne Peters
    • Santa Barbara, California, United States, 93105
      • Recruiting
      • Sansum Diabetes Research Institute
      • Principal Investigator: Kristin Castorino
      • Contact: Juliana Lopez; Phone Number: 8057059465; Email: jlopez@sansum.org
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • University of Colorado
      • Principal Investigator: Gregory Forlenza
      • Contact: Estella Escobar; Phone Number: (720) 305-7817; Email: Estella.Escobar@cuanschutz.edu
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Not yet recruiting
      • Yale
      • Contact: Amy Steffen; Phone Number: 203-737-8852; Email: Amy.steffen@yale.edu
      • Principal Investigator: Amy Steffen
  • Florida
    • Tampa, Florida, United States, 33612
      • Not yet recruiting
      • University of South Florida
      • Contact: Janet Rodriguez; Phone Number: 813-821-8011; Email: janetrodriguez@usf.edu
      • Principal Investigator: Dorothy Shulman
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Not yet recruiting
      • Emory University
      • Contact: Sabeena Usman
      • Principal Investigator: Georgia Davis
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
      • Northwestern University
      • Principal Investigator: Grazia Aleppo
      • Contact: Evelyn Fronczyk; Phone Number: 312-908-9002; Email: Evelyn.guevara@northwestern.ed
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Indiana University
      • Principal Investigator: Viral Shah
      • Contact: Kathy Bohanan; Phone Number: 317-278-0651; Email: kkremer@iu.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Joslin Diabetes Center
      • Principal Investigator: Lori Laffel
      • Contact: Louise Ambler-Osborn; Phone Number: 617-975-8206; Email: louise.ambler-osborn@joslin.harvard.edu
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health Systems
      • Principal Investigator: Davida Kruger
      • Contact: Lydia Oehring; Phone Number: +1 (313) 916-3906; Email: loehrin1@hfhs.org
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Recruiting
      • Health Partners
      • Contact: Stephanie Zimmerman; Phone Number: 952-993-2048; Email: H.Zimmerman@HealthPartners.com
      • Principal Investigator: Amy Criego
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Baylor College of Medicine
      • Contact: Anh Nguyen; Phone Number: (832) 822-3870; Email: Anh.Nguyen2@bcm.edu
      • Principal Investigator: Daniel DeSalvo

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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
• If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

• 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
• Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omnipod 5 System	Device: Omnipod 5 System; The Omnipod 5 System with the study CGM
Experimental: Omnipod 6 System	Device: Omnipod 6 System; The Omnipod 6 System with the study CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total boluses per day	Total blues per day will be compared between Omnipod 6 and Omnipod 5	13 weeks
Total daily insulin per kg and total insulin delivered via automation	Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5	13 weeks
Percentage of time in automated mode	Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5	13 weeks
Percentage with HbA1c <7.0% and <7.5%	Percentage with HbA1c <7.0% and <7.5% will be compared between Omnipod 6 and Omnipod 5	13 weeks
Percentage with >= 70% time in range	Percentage with >= 70% time in range will be compared between Omnipod 6 and Omnipod 5	13 weeks
Percentage with >= 50% time in range	Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5	13 weeks
Diabetes treatment satisfaction	Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6	13 weeks
System Usability	Patient Reported Outcome Survey evaluated at the end of each 13-week period	13 weeks
System Opinion	Patient Reported Outcome Survey evaluated at the end of each 13-week period	13 weeks
Health Related Quality of Life (HR-QOL)	Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6	13 weeks
Hypoglycemia confidence	Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6	13 weeks
Missed Meal - Peak glucose	Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5	13 weeks
Missed Meal - AUC	AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5	13 weeks
Missed Meal - Time in Range	Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5	13 weeks
Missed Meal - Percentage of Time > 180 mg/dL	Percentage of Time > 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5	13 weeks
Missed Meal - Percentage of Time > 250 mg/dL	Percentage of Time > 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5	13 weeks
Missed Meal - Percentage of Time <54 mg/dL	Percentage of Time <54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5	13 weeks
Missed Meal - Percentage of Time <70 mg/dL	Percentage of Time <70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5	13 weeks
Number of severe hypoglycemic events		13 weeks
Number of DKA or HHS events		13 weeks
Other related serious adverse events		13 weeks
Unanticipated adverse device effects		13 weeks
Reportable device-related adverse events		13 weeks

Collaborators and Investigators

• Sponsor: Insulet Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Type 1 Diabetes; T1D; T2D; Automated Insulin Delivery; Omnipod; AID
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STRIVE 2

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