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

Not Applicable

Completed

Brief Summary: 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: 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:

1. SAP=sensor-augmented pump only

2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight

3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group B	CLC	Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP 1. SAP=sensor-augmented pump only 2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight 3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
Group A	CLC	Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d) 1. SAP=sensor-augmented pump only 2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight 3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	8 weeks	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.
Time <70 mg/dl by CGM	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Low Blood Glucose Index (LBGI)	8 weeks	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).
Hemoglobin A1c by Study Session	8 weeks	Hemoglobin A1c after each 8 weeks study session by Group A and Group B.
Time Between 70-180 mg/dL by CGM	8 weeks	Time in target range 70-180 mg/dL measured by CGM
Time >180 mg/dL by CGM	8 weeks	Time in hyperglycemia range \>180 mg/dL measured by CGM
Mean Glucose by CGM	8 weeks	Mean glucose measured by CGM overall in mmol/L
CGM <70mg/dL	8 weeks	Percentage time \<70mg/dL measured by CGM in three study phases combining Group A and B.
High Blood Glucose Index (HBGI)	8 weeks	Index measure of high blood glucose risk.

Locations (1): University of Virginia Center for Diabetes Technology
🇺🇸
Charlottesville, Virginia, United States