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

University of Virginia

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: CLC

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02679287

18617

R01DK085623 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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:

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

Enrollment: 103 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Device: CLC

Group B

Experimental group

Description:

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

Treatment:

Device: CLC