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

Insulet

Status

Enrolling

Conditions

Diabetes Mellitus, Type 1, Type 2

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 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.

Enrollment

160 estimated patients

Sex

All

Ages

2 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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
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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

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