Omnipod 5 System Compared to Pump Therapy

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system. Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.

Key facts

Study ID

NCT05409131

Run by

Insulet Corporation

People needed

196

Starts

2022-07-07

Expected to finish

2025-01-10

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age at time of consent 18-70 years of age
• Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
• On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating.
• A1C 7.0-11.0% by point-of-care taken at screening visit
• Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment
• Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study
• Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
• Willing to wear the system continuously throughout the study
• Willing and able to sign the Informed Consent Form (ICF)

You may not qualify if…

• Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk
• History of severe hypoglycemia in the past 6 months
• History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure
• Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C.
• Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.
• Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
• Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the Baseline Visit. Participants taking metformin should remain on a steady dose during study participation.
• Pregnant or lactating, or is a woman 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 5 half-lives (whichever is longer) prior to screening, 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

Where it is running

• Stanford University School of Medicine — Palo Alto, California, United States
• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• Atlanta Diabetes — Atlanta, Georgia, United States
• Northwestern University — Evanston, Illinois, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• State University of New York, Upstate Medical University — Syracuse, New York, United States
• Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic) — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Hopital Sud-Francilien — Corbeil-Essonnes, France
• Hospices Civils de Lyon - Centre du diabete Diab-eCare — Lyon, France
• CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition — Montpellier, France
• Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications — Paris, France

Full record on ClinicalTrials.gov

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