Omnipod 5 System Compared to Pump Therapy
Trial ID or NCT#
NCT05409131
Status
NOT RECRUITING
Purpose
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.
Official Title
Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial
Eligibility Criteria
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Age at time of consent 18-70 years of age2. Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.3. 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.4. A1C 7.0-11.0% by point-of-care taken at screening visit5. Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment6. Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study7. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol8. Willing to wear the system continuously throughout the study9. Willing and able to sign the Informed Consent Form (ICF)
Exclusion Criteria:
- 1. 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 risk2. History of severe hypoglycemia in the past 6 months3. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure4. 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.5. 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.6. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement7. 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.8. 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)9. 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 period10. 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 judgment11. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned
Investigator(s)
Michael Samuel Hughes
Instructor, Medicine - Endocrinology, Gerontology, & Metabolism
Masters Student in Clinical Informatics Management, admitted Summer 2024
View on ClinicalTrials.gov
