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

Official title

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

Overview

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.

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

Interventions

• Device Omnipod 5 System
  The Omnipod 5 System with the study CGM
• Device Omnipod 6 System
  The Omnipod 6 System with the study CGM

Primary outcome measures

• Time in Range 70-180 mg/dL [Time frame: 13 weeks]
• Time <54 mg/dL [Time frame: 13 weeks]
• Time <70 mg/dL [Time frame: 13 weeks]
• Time >180 mg/dL [Time frame: 13 weeks]
• Time in Range 70-140 mg/dL [Time frame: 13 weeks]
• HbA1c [Time frame: 13 weeks]
• Mean sensor glucose [Time frame: 13 weeks]
• Time >250 mg/dL [Time frame: 13 weeks]

Secondary outcome measures (12)

• Total boluses per day [Time frame: 13 weeks]
• Total daily insulin per kg and total insulin delivered via automation [Time frame: 13 weeks]
• Percentage of time in automated mode [Time frame: 13 weeks]
• Percentage with HbA1c <7.0% and <7.5% [Time frame: 13 weeks]
• Percentage with >= 70% time in range [Time frame: 13 weeks]
• Percentage with >= 50% time in range [Time frame: 13 weeks]
• Diabetes treatment satisfaction [Time frame: 13 weeks]
• System Usability [Time frame: 13 weeks]
• System Opinion [Time frame: 13 weeks]
• Health Related Quality of Life (HR-QOL) [Time frame: 13 weeks]
• Hypoglycemia confidence [Time frame: 13 weeks]
• Missed Meal - Peak glucose [Time frame: 13 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 11 centers

• University of Southern California — Los Angeles
• Sansum Diabetes Research Institute — Santa Barbara
• University of Colorado — Aurora
• Yale — New Haven
• Emory University — Atlanta
• Northwestern University — Chicago
• Indiana University — Indianapolis
• Joslin Diabetes Center — Boston
• … and 3 more centers

Identifiers

NCT: NCT07579702 · STRIVE 2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗