Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 Diabetes (STRIVE)

Insulet

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 1

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06865989

STRIVE (Other Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 2 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age at time of consent 2-70 years (inclusive)
2. 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. Diagnosis is based on investigator's clinical judgment
3. Living with a parent or guardian if < 18 years old
4. Current Omnipod 5 user for at least 3 months prior to screening
5. 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
6. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog or their generic equivalents
7. Participant agrees to provide their own insulin for the duration of the study
8. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
9. Willing to wear the system continuously throughout the study
10. 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
11. Able to read and understand English
12. If of childbearing potential, willing and able to have pregnancy testing

Exclusion criteria

1. Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
2. Any planned surgery during the study which could be considered major
3. 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.
4. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion failure
5. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
6. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
7. Use of hydroxyurea
8. Use of non-insulin anti-hyperglycemic 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
9. 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)
10. 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.
11. Planned international travel during the study
12. 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
13. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Omnipod 5 SmartAdjust 2.0 System

Experimental group

Description:

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.

Treatment:

Device: Omnipod 5 System

Device: Omnipod 5 SmartAdjust 2.0 System

Omnipod 5 System

Active Comparator group

Description:

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.

Treatment:

Device: Omnipod 5 System

Device: Omnipod 5 SmartAdjust 2.0 System