Overnight Closed Loop Study in U.S.

Study Overview
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Brief Summary
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This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.

Detailed Description
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Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing. The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American. The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.

Official Title
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In-Clinic Feasibility Study to Observe the Overnight Closed Loop System

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Hybrid Closed Loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 2-75 years of age at time of screening A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures : Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening Adequate venous access as assessed by investigator or appropriate staff Subject should have an established insulin carbohydrate and insulin sensitivity ratio. Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 75 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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: subjects undergo treatment with the hybrid closed loop system under various experimental conditions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Closed Loop<br>In-clinic evaluation of the HCL System under various conditions. | Device: Hybrid Closed Loop<br>* The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform) | time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions. | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time in Euglycemic Range - Exploratory A Phase | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Exploratory A phase. An overnight closed-loop experiment was performed using the Android Development Platform, software version 2.0 A system's closed-loop algorithm without implementing the upper-limit for insulin delivery. | 1 day | 
| Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase | The purpose of exploratory B study was to evaluate the efficacy and safety of the insulin upper-limit, Umax. The Umax is a patient-specific parameter which is calculated based on historical data from the pump that includes SG tracings, insulin delivery information, and the carbohydrate inputs from the user. The main objective of Umax is to prevent the user from being severely hypoglycemic (less than 50 mg/dL) by restricting the controller from over-delivery of insulin. | 1 day | 
| Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1 | Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1 | 1 day | 
| Percentage of Time in Euglycemic Range - Phase 2 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2 | 3 days | 
| Percentage of Time in Euglycemic Range - Phase 4 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4 | 12 days | 
| Percentage of Time in Euglycemic Range - Phase 6 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6 | 7 days | 
| Percentage of Time in Euglycemic Range - Phase 7 | Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7 | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCL, Type 1 Diabetes, Sensor