Clinical trial NCT02679287: Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
Official title: Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Closed-Loop Control (CLC)
Sensor-Augmented Therapy (SAP)
USS Virginia
Continuous Glucose Monitor (CGM)
Insulin Pump
Artificial Pancreas (AP)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Roche Diagnostic Ltd.
name: TypeZero Technologies, LLC
name: Tandem Diabetes Care, Inc.
name: DexCom, Inc.
First posted: 2016-02-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Time <70 mg/dl by CGM
timeFrame: 8 weeks
measure: Hemoglobin A1c
timeFrame: 8 weeks
Secondary outcomes:
measure: Time Between 70-180 mg/dL by CGM
timeFrame: 8 weeks
measure: Time >180 mg/dL by CGM
timeFrame: 8 weeks
measure: Mean Glucose by CGM
timeFrame: 8 weeks
measure: Low Blood Glucose Index (LBGI)
timeFrame: 8 weeks
measure: High Blood Glucose Index (HBGI)
timeFrame: 8 weeks
measure: CGM <70mg/dL
timeFrame: 8 weeks
measure: Hemoglobin A1c by Study Session
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: UVA Center for Diabetes Technology
name: Sue A. Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kovatchev BP, Kollar L, Anderson SM, Barnett C, Breton MD, Carr K, Gildersleeve R, Oliveri MC, Wakeman CA, Brown SA. Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial. Lancet Digit Health. 2020 Feb;2(2):e64-e73. doi: 10.1016/S2589-7500(19)30218-3. Epub 2020 Jan 3.