Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive. Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use. Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use. Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
• Age at time of consent 18-75 years
• Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus (12 subjects) or basal only (12 subjects) regimens
• A1C 8.0-12.0%
• Has not used an insulin pump within 3 months of screening
• Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
• Maximum insulin dose of 200 units/day
• Stable doses over the last 4 weeks of other glucose-lowering medications as determined by Investigator
• Willing to wear the system continuously throughout the study
• Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
⁃ Investigator has confidence that the subject has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
⁃ Must be willing to use the Dexcom App on the Omnipod 5 PDM as the sole source of Dexcom data (except for the Dexcom Follow App) during Automated Mode
⁃ Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight
⁃ Able to read and speak English fluently
⁃ Willing and able to sign the Informed Consent Form (ICF)