Safety and Efficacy of the Omnipod? 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes

Primary Objective

The study is being done to learn if an automated insulin delivery system (the Omnipod 5) can safely adjust insulin for diabetes management in individuals with type 2 diabetes.

This Study is
No Longer Enrolling

Description

This single-arm, multi-center, prospective study will evaluate the safety (primary) and efficacy (secondary) of the Omnipod? 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.

Details
Age

Adult

Eligibility

1. Age at time of consent 18-75 years 2. Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix) 3. Basal bolus (long-acting insulin and rapid acting analog) or premix users with A1C <12.0% OR basal users on long or intermediate acting insulin only with A1C > 8.0% and < 12.0% 4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog 5. Participant agrees to provide their own insulin for the duration of the study

Inclusion Criteria: Participants must meet all of the following criteria to be included in the study: 1. Age at time of consent 18-75 years 2. Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix) 3. Basal bolus (long-acting insulin and rapid acting analog) or premix users with A1C <12.0% OR basal users on long or intermediate acting insulin only with A1C > 8.0% and < 12.0% 4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog 5. Participant agrees to provide their own insulin for the duration of the study 6. Stable doses over the preceding 4 weeks of other glucose lowering medications as determined by Investigator 7. Stable doses of weight loss medications over the preceding 4 weeks and throughout the study that may affect glycemic control directly and/or indirectly, except for a dose reduction or discontinuation, as determined by Investigator 8. Willing to wear the system continuously throughout the study 9. Deemed appropriate for pump therapy per investigator’s assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities 10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol 11. Able to read and understand English 12. Willing and able to sign the Informed Consent Form (ICF) 13. If female of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study: 1. Use of an AID pump in automated mode within 3 months prior to screening 2. Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia) 3. Current or known history of coronary artery disease that is not stable with medical management, 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 4. Any planned surgery during the study which could be considered major in the opinion of the investigator 5. History of more than 1 severe hypoglycemic event in the 6 months prior to screening 6. History of more than 1 episode of diabetic ketoacidosis (DKA) or Hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening; unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis 7. 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 8. Plans to receive blood transfusion over the course of the study 9. Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study 10. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement 11. Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant) 12. Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the study period

Type of Study

Device Feasibility

Scope

National

Locations

Anschutz Health and Wellness
Barbara Davis Center
Lone Tree Medical Center

Study ID

Protocol Number: 23-0388

More information available at ClinicalTrials.gov: NCT05815342

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