Insulet Artificial Pancreas Early Feasibility Study

Study Overview
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Brief Summary
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The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.

Official Title
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A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Insulet Artificial Pancreas (AP) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment. Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day and A1C > 6% at screening Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump for at least 6 months prior to start of study Willing to use the study CGM device for one week prior to study start and for the duration of the study Willing to use the OmniPod® Insulin Management System during the study Willing to perform all SMBG testing with the study-approved glucose meter at the frequency specified in the study protocol Willing to abide by meal recommendations for breakfast, lunch and dinner during the study Willing to refrain from use of acetaminophen, pseudoephedrine, 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 or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: A1c >10% at the Screening visit One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months Hypoglycemic unawareness as determined by a score of 4 or more R responses on the Clarke Questionnaire One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months Used non-insulin anti-diabetic medication within last 30 days 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 wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor on the abdomen Known history of myocardial infarction (MI) or stroke within the past 6 months 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 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 testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Cohort in CRC<br>This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. | Device: Insulet Artificial Pancreas (AP) System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in hypoglycemic range (defined as <70 mg/dL) |  | 36 hours | 
| Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL) |  | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean glucose |  | 36 hours | 
| Percentage of time < 50 mg/dL |  | 36 hours | 
| Percentage of time < 60 mg/dL |  | 36 hours | 
| Percentage of time > 180 mg/dL |  | 36 hours | 
| Percentage of time >/= 300 mg/dL |  | 36 hours | 
| Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL) |  | 36 hours | 
| Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL) |  | 36 hours | 
| Standard deviation and coefficient of variation of CGM values |  | 36 hours |