Insulet Artificial Pancreas Free-Living IDE3
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byBruce Buckingham, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Insulet Corporation
No Placebo Group
Trial Summary
What is the purpose of this trial?
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
Eligibility Criteria
Inclusion Criteria
Age at time of consent 2.0-85 years
Individuals aged ≥6.0 must be diagnosed with type 1 diabetes for at least one year. Preschool children aged 2.0-5.9 years must be diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment.
A1C <10% at screening
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Treatment Details
Interventions
- Insulet Artificial Pancreas (Automated Glucose Control System)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Supervised Free-LivingExperimental Treatment1 Intervention
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting, where subjects will participate in specific setpoint challenges, meal challenges, and exercise
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Colorado DenverDenver, CO
Yale University School of MedicineNew Haven, CT
Stanford UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Insulet CorporationLead Sponsor