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Compares treatment options for Type 2 Diabetes Mellitus
Official title Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System
ClinicalTrials.gov ID: NCT07579702
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 75
You may be able to join if
- 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...
You likely can't join 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...
- 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...
- History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or...
- Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Santa Barbara, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Santa Barbara, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.