No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
14 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Insulet Corporation · Industry
Who this trial is looking for
This trial is looking for people aged 14 to 75 with type 1 or type 2 diabetes who have trouble controlling their blood sugar. Participants will use the Omnipod 6 System to see how well it works compared to the Omnipod 5 System.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 14 and 75 years old.
I have type 1 diabetes for at least 6 months or type 2 diabetes for at least 1 year.
I currently use a continuous glucose monitor.
I have an HbA1c level of 7.5% or higher.
I average less than 4 user-initiated boluses per day.
I am willing to use approved types of U-100 insulin during the study.
I can read and understand English.
I am willing to sign a consent form.
You may not be able to join if
I have had a severe hypoglycemia event in the past 6 months.
I have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state in the past 6 months.
I have any medical condition that would put me at an unacceptable safety risk.
I have a current or known history of unstable coronary artery disease.
I cannot tolerate adhesive tape or have a skin condition in the area of sensor or pump placement.
I am pregnant or breastfeeding.
I have taken systemic steroids in the past 4 weeks.
I am an employee of Insulet or related to someone on the study team.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 …
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
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