Insulet Artificial Pancreas Free-Living IDE3

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
The study schedule will consist of a standard therapy data collection week followed by a hybrid closed-loop phase. 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. The hybrid closed-loop phase will begin prior to lunch on Study Day 1. During the hybrid closed-loop phase, subjects will participate in specific setpoint challenges, meal challenges, and exercise. Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study Day 5. Subjects will be asked to complete a post-study questionnaire regarding their experience with the system. Subjects will be discharged home when stable and all discharge criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid closed-loop before they leave the study site.

Official Title
-----------------
Evaluating Glucose Control in Patients With Type 1 Diabetes Under Free-living Conditions With the Insulet Automated Glucose Control System: IDE3

Conditions
-----------------
Type1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Insulet automated glucose control system


Participation Criteria
=================
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 Currently using U-100 rapid-acting insulin analogs with insulin pump or receiving multiple daily injections suitable for conversion to pump therapy for at least 3 months prior to study start Willing to use the study CGM device for the duration of the study Willing to use the Omnipod® Insulin Management System during the study Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol or per investigator discretion Willing to participate in setpoint and meal challenges Willing to use carbohydrate counting for determination of meal boluses Willing to participate in moderate intensity exercise for at least 30 minutes per day Willing to refrain from use of acetaminophen and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study 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 per State requirements. Exclusion Criteria: One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months Planning to start a non-insulin anti-diabetic medication during the study. If on non-insulin medication, dose must be stable in the previous 30 days. Using a basal insulin with a usual duration of insulin action > 36 hours 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) Dermatological conditions at the proposed sensor/pump wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor 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. Abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QT interval (> 440 ms). Electrocardiogram is only required for subjects >50 years old or with diabetes duration >20 years. Stroke Known history of seizure disorder Known history of adrenal insufficiency Current renal or hepatic disease Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment) Currently undergoing cancer treatment Currently undergoing systemic treatment with steroids or immunosuppressive medication Known history of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants Current illness that would interfere with participation in the study Untreated or inadequately treated mental illness Current alcohol abuse per investigator's judgment Electrically-powered implants that may be susceptible to RF interference Currently participating in another clinical study using an investigational drug or device Recent (within the preceding 30 days) participation in a clinical study using an investigational drug Unable to follow the clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a single-arm, multi-center, observational clinical study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Supervised Free-Living<br>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 | Device: Insulet automated glucose control system<br>* Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in hypoglycemic range (defined as < 70 mg/dL) |  | 96 hours | 
| Percentage of time in hyperglycemic range (defined as ≥ 250 mg/dL) |  | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glucose |  | 96 hours | 
| Percentage of time < 50 mg/dL |  | 96 hours | 
| Percentage of time < 54 mg/dL |  | 96 hours | 
| Percentage of time < 60 mg/dL |  | 96 hours | 
| Percentage of time > 180 mg/dL |  | 96 hours | 
| Percentage of time ≥ 300 mg/dL |  | 96 hours | 
| Percentage of time between 70-180 mg/dL |  | 96 hours | 
| Percentage of time between 70-140 mg/dL |  | 96 hours | 
| Standard deviation | Using CGM measurements, the Standard deviations will be reported for the entire hybrid closed-loop phase overall, as well as separately during the day (0700 - 2259h) and during the night (2300 - 0659h). | 96 hours | 
| Coefficient of variation | Using CGM measurements, the Coefficient of variation will be reported for the entire hybrid closed-loop phase overall, as well as separately during the day (0700 - 2259h) and during the night (2300 - 0659h). | 96 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T1D, Omnipod