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

University of Virginia103 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Diabetes Mellitus, Type 1

Interventions

CLCDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 8 weeks

Secondary Outcomes

Time Between 70-180 mg/dL by CGM

Time in target range 70-180 mg/dL measured by CGM

Time frame: 8 weeks

Time >180 mg/dL by CGM

Time in hyperglycemia range \>180 mg/dL measured by CGM

Time frame: 8 weeks

Mean Glucose by CGM

Mean glucose measured by CGM overall in mmol/L

Time frame: 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).

Time frame: 8 weeks

High Blood Glucose Index (HBGI)

Index measure of high blood glucose risk.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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