None listed
Conditions
Brief summary
This feasibility study is a prospective, single arm study evaluating the Omnipod 5 SmartAdjust 2.0 System in adults and children with type 1 diabetes, and in adults with type 2 diabetes. Participants will undergo 2 weeks of Standard Therapy while using a Dexcom G6 CGM in an outpatient setting before proceeding to Period 1. In Period 1, participants will use the Omnipod 5 SA2.0 System in an outpatient setting for up to 6 weeks. During weeks 3-6, participants will be instructed not to exceed 3 meal boluses/day. At the conclusion of Period 1, participants may transition to the optional extension portion of the study (Period 2), for up to an additional 6 months of unrestricted use of the Omnipod 5 SA2.0 System.
Interventions
This single-arm study will enroll up to 75 participants aged 2-70 years with Type 1 diabetes and aged 16-70 years with Type 2 diabetes to initiate the use of the Omnipod 5 SmartAdjust 2.0 (SA 2.0) System. This is an Automated Insulin Delivery (AID) system which requires Continuous Glucose Monitoring (CGM) combined with an insulin pump and an algorithm that adapts insulin delivery in real time to target normal glucose levels. The Omnipod 5 AID System has a novel algorithm with customizable gluco
This single-arm study will enroll up to 75 participants aged 2-70 years with Type 1 diabetes and aged 16-70 years with Type 2 diabetes to initiate the use of the Omnipod 5 SmartAdjust 2.0 (SA 2.0) System. This is an Automated Insulin Delivery (AID) system which requires Continuous Glucose Monitoring (CGM) combined with an insulin pump and an algorithm that adapts insulin delivery in real time to target normal glucose levels. The Omnipod 5 AID System has a novel algorithm with customizable glucose targets and unique configuration utilizing a tubeless insulin pump (Pod), which is a small adhesive patch pump worn on the body. The cannula is automatically deployed directly under the Pod, creating an infusion site without external tubing. The Pod is worn continuously for up to 72 hours. All user interactions are conducted wirelessly through a mobile App on a Smartphone. The Omnipod 5 System is FDA cleared for patients with Type 1 Diabetes with over 250,000 users on the product. The investigational Omnipod 5 SA2.0 AID System is comprised of the following components: a modified version of the current US commercial Omnipod 5 Pod (Omnipod 5 SA2.0 Pod), and a modified version of the current US commercial Omnipod 5 App on a compatible Smartphone (Omnipod 5 SA2.0 App). Participants will undergo 2 weeks of Standard Therapy while using a Dexcom G6 CGM in an outpatient setting before proceeding to Period 1. Participants will have a blinded Dexcom G6 placed on body, marking commencement of Standard Therapy. During Standard Therapy, participants will continue to wear the blinded Dexcom G6 and manage their diabetes at home using their current insulin therapy routine. After the completion of Standard Therapy, participants will receive specific training to use the Omnipod SA2.0 System. The training will be face-to-face, in a single two-hour session, and be provided by a member of the research team. Clinical study staff will go through step-by-step instruction and confirm that participants understand how to use the Omnipod 5 SA2.0 System, including how to change the Pods and administer a bolus. Period 1: Participants will use the Omnipod 5 SA2.0 System in an outpatient setting for up to 6 weeks. Participants will use U-100 rapid-acting insulin analogs (Humalog U-100, Novorapid) with the Omnipod 5 SA2.0 System. During weeks 1-2, participants will have to manually prompt meal boluses through the Omnipod 5 SA2.0 App. During weeks 3-6, participants will be instructed not to exceed 3 meal boluses/day. Period 2: At the conclusion of Period 1, participants may transition to the optional extension portion of the study for up to an additional 6 months using the Omnipod 5 SA2.0 System. There will not be any meal bolus restrictions during Period 2, participants may use the Omnipod 5 SA2.0 System freely. Device analytics will be used to monitor adherence to the intervention.
Sponsors
University of Otago, Christchurch.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age at time of consent 2-70 years 2. Diabetes diagnosis, based on Investigator's clinical judgement, and meets the following: -Type 1 diabetes: 2-70 years old with HbA1c <11%. Diagnosed for at least 6 months for participants aged 2-<7 years or at least 1 year for participants aged 7-70 years. Or -Type 2 diabetes: 16-70 years old, diagnosed with T2D and on current insulin regimen for at least 3 months. Includes basal-bolus, pre-mix, or basal only users. For basal-bolus and premix users, must have HbA1c <12%. For basal only users must have HbA1c >=7.0% and <12%. 3. Living with a parent or guardian if < 16 years old 4. Currently using U-100 rapid-acting insulin analogs with insulin pump or basal-bolus, pre-mix, or basal only users suitable for conversion to pump therapy for at least 3 months prior to study start 5. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novorapid, or their generic equivalents 6. Deemed appropriate for pump therapy per Investigator’s assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities 7. Stable doses over the preceding 4 weeks of other glucose lowering medications, as determined by Investigator, including within class dose equivalent medication 8. Stable doses over the preceding 4 weeks of weight loss medications that may affect glycemic control directly and/or indirectly, as determined by Investigator 9. Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol 10. Willing to wear the system, including Pods, continuously throughout the study 11. If female of childbearing potential, willing and able to have pregnancy testing
Exclusion criteria
1. Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk 2. 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 3. Any planned surgery during the study which could be considered major in the opinion of the Investigator 4. Severe retinopathy based on retinal screening performed within the last 24 months 5. History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions 6. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure 7. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 8. 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 9. Plans to receive blood transfusion over the course of the study 10. 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) 11. Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period 12. 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 13. Participant is an employee of Insulet, an Investigator or Investigator’s study team, or immediate family member of any of the aforementioned
Outcome results
None listed