RecruitingType 2 Diabetes MellitusType 1 Diabetes Mellitus

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

Eligible age

14–75 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: Insulet Corporation

You may qualify 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 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.

You may not qualify 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, 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