Prepivotal Omnipod Horizon™ Automated Glucose Control System
Trial ID or NCT#
NCT04176731
Status
NOT RECRUITING
Purpose
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.
Official Title
Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
Eligibility Criteria
Ages Eligible for Study: 6 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Age at time of consent/assent 6-70 years 2. Subjects aged < 18 years must be living with parent/legal guardian 3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment. 4. Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities 5. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol 6. Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog, or Apidra during the study 7. Must be willing to set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase 8. Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria 9. Willing to wear the system continuously throughout the study 10. A1C <10% at screening visit 11. Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase 12. 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 13. Able to read and speak English fluently 14. Subject must be in an AT&T covered area 15. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged < 18 years per State requirements.
Exclusion Criteria:
- 1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk 2. History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months 3. History of DKA (as defined in Section 11.3.4) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis 4. Diagnosed with sickle cell disease 5. Diagnosed with hemophilia or any other bleeding disorders 6. Plans to receive blood transfusion over the course of the study 7. Currently diagnosed with anorexia nervosa or bulimia 8. Acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis 9. History of adrenal insufficiency 10. Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the course of the study 11. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 12. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study 13. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide) 14. 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 previous 12 months. 15. For subjects >50 years old or with diabetes duration >20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms) 16. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism 17. Pregnant or lactating, 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) 18. Participation in another clinical study using an investigational drug or device within the preceding 30-days or intends to participate during the study period 19. 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.
Investigator(s)
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
View on ClinicalTrials.gov
