Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes

NCT06865989 | Completed FDA Device

• 1 other identifier: STRIVE
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 11

Brief Summary

The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.

Conditions

Diabetes Mellitus, Type 1, Type 2

Keywords

T1D; Omnipod; Omnipod 5; T2D

Outcome Measures

Primary Outcomes (4)

• Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%)

  Glucose metric from continuous glucose monitoring system

  End of Period 2 (Day 56) compared to Baseline

• Percent of time in range <70 mg/dL (non-inferiority margin of 3.0%)

  Glucose metric from continuous glucose monitoring system

  End of Period 2 (Day 56) compared to Baseline

• Percent of time in range 70-180 mg/dL (non-inferiority margin of 3.0%)

  Glucose metric from continuous glucose monitoring system

  End of Period 2 (Day 56) compared to Baseline

• Mean Glucose (non-inferiority margin of 8 mg/dL)

  Glucose metric from continuous glucose monitoring system

  End of Period 2 (Day 56) compared to Baseline

Study Arms (2)

Omnipod 5 SmartAdjust 2.0 System

EXPERIMENTAL

A subset of participants will begin the study using the Omnipod 5 SmartAdjust 2.0 System then switch to the comparator, and back again to the experimental system.

Device: Omnipod 5 SmartAdjust 2.0 System; Device: Omnipod 5 System

Omnipod 5 System

ACTIVE COMPARATOR

A subset of participants will begin the study using the Omnipod 5 System then switch to the experimental system for the remainder of the study.

Device: Omnipod 5 SmartAdjust 2.0 System; Device: Omnipod 5 System

Interventions

Omnipod 5 SmartAdjust 2.0 System DEVICE

Omnipod 5 System with changes

Omnipod 5 SmartAdjust 2.0 System; Omnipod 5 System

Omnipod 5 System DEVICE

Cleared device as comparator

Omnipod 5 SmartAdjust 2.0 System; Omnipod 5 System

Eligibility Criteria

• Age: 2 Years - 70 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 2-70 years (inclusive)
• Diabetes diagnosis, based on Investigators clinical judgement, and meets the following:
• Diagnosed with type 1 diabetes for at least 3 months for participants aged 2 - \< 7 years and at least 1 year for participants aged 7 - 70 years. OR 18-70 years old, diagnosed with type 2 diabetes for at least 1 year
• Living with a parent or guardian if \< 18 years old
• Omnipod 5 user who has used U-100 insulin or their generic equivalents with the Omnipod 5 system for at least 3 months prior to screening
• Must have used the target of 110mg/dl for at least 30% of the time for 2-13 year olds and for at least 50% of the time for 14-70 year olds for the 2 weeks preceding the screening visit
• Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
• Participant agrees to provide their own insulin for the duration of the study
• Stable doses over the preceding 4 weeks of non-insulin glucose lowering or weight loss medications that have a meaningful effect on glycemia, as determined by the investigator
• Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
• 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 pediatric and adolescent participants aged \< 18 years per state requirements
• Able to read and understand English
• If of childbearing potential, willing and able to have pregnancy testing

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
• 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
• For type 1 participants only. Use of non-insulin glucose-lowering medication other than metformin and GLP1, in the 4 weeks prior to screening. Participants taking metformin and/or GLP1 should remain on a steady dose during study participation
• 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)
• In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device. Additionally, may not intend to participate in any other clinical study during this study period.
• Planned international travel during the study
• 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

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (11)

University of Southern California

Los Angeles, California, 90022, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gregory Forlenza, MD

  Barbara Davis Center

  STUDY CHAIR

Study Design

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

Model Details: Randomized two-sequence, multi-center crossover study

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 26, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (11)