Omnipod 5 System Compared to Pump Therapy (NCT05409131) | Clinical Trial Compass
CompletedNot Applicable
Omnipod 5 System Compared to Pump Therapy
United States196 participantsStarted 2022-07-07
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Percent of Time in Range 70-180 mg/dL
Timeframe: Comparing intervention group with control group during the 13-week study phase
✕. 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)