Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control

Study Overview
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Brief Summary
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The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.

Detailed Description
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The CLC is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.These functionalities occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are: SAP=sensor-augmented pump only USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Official Title
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Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: CLC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes for at least one year using insulin for at least 1 year an insulin pump for at least 6 months willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra). Exclusion Criteria: a medical condition or being been treated with medications that might interfere with the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d) SAP=sensor-augmented pump only USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control | Device: CLC<br>* The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.<br>* Other names: Closed Loop Control;|
| Experimental: Group B<br>Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP SAP=sensor-augmented pump only USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control | Device: CLC<br>* The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.<br>* Other names: Closed Loop Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time <70 mg/dl by CGM | Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs ≥7.5% and time of day. | 8 weeks | 
| Hemoglobin A1c | Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs ≥7.5% and time of day. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Between 70-180 mg/dL by CGM | Time in target range 70-180 mg/dL measured by CGM | 8 weeks | 
| Time >180 mg/dL by CGM | Time in hyperglycemia range >180 mg/dL measured by CGM | 8 weeks | 
| Mean Glucose by CGM | Mean glucose measured by CGM overall in mmol/L | 8 weeks | 
| Low Blood Glucose Index (LBGI) | Index measure of low blood glucose risk. This is an index that indicates risk of hypoglycemia with low values indicating lower risk of hypoglycemia (particularly values 1 or lower). | 8 weeks | 
| High Blood Glucose Index (HBGI) | Index measure of high blood glucose risk. | 8 weeks | 
| CGM <70mg/dL | Percentage time <70mg/dL measured by CGM in three study phases combining Group A and B. | 8 weeks | 
| Hemoglobin A1c by Study Session | Hemoglobin A1c after each 8 weeks study session by Group A and Group B. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed-Loop Control (CLC), Sensor-Augmented Therapy (SAP), USS Virginia, Continuous Glucose Monitor (CGM), Insulin Pump, Artificial Pancreas (AP)