Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.

Key facts

Study ID

NCT04476472

Run by

Insulet Corporation

People needed

80

Starts

2020-09-08

Expected to finish

2022-10-12

Last updated by the study team

2024-02-14

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age at time of consent 2.0-5.9 years
• Living with parent/legal guardian
• Diagnosed with type 1 diabetes. Diagnosis is based on investigator's clinical judgment
• Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
• Investigator has confidence that the subject and/or parent/guardian/caregiver can successfully operate all study devices and is capable of adhering to the protocol
• Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
• Willing to wear the system continuously throughout the study
• Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50%
• A1C <10% at screening visit
• Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
• Subject and/or parent/guardian is able to read and speak English fluently
• Has a parent/legal guardian willing and able to sign the ICF.

You may not qualify if…

• A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
• History of severe hypoglycemia in the past 6 months
• History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
• Diagnosed with sickle cell disease
• Diagnosed with hemophilia or any other bleeding disorders
• Plans to receive blood transfusion over the course of the study
• Clinical evidence of acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
• History of adrenal insufficiency
• Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the course of the study
• Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
• Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
• Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
• Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
• Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System 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

Where it is running

• Stanford University — Palo Alto, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Atlanta Diabetes — Atlanta, Georgia, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• International Diabetes Center — Saint Louis Park, Minnesota, United States
• SUNY Syracuse — Syracuse, New York, United States
• University Hospitals Cleveland — Cleveland, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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