MedTrace Logo

Full Day and Night Closed-Loop With DiAs Platform

NCT02147860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-07-19

No results posted yet for this study

Summary

The overall aim of this proposed research is to determine the safety, feasibility and efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting. This will be addressed in two parts: 1) An in residence, outpatient study to determine safety and feasibility of the DiAs during 72 continuous hours of day and night glucose control; and 2) Camp studies planned for the summer of 2014 with randomization to either full closed-loop or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Diabetes Assistant (DiAs) with USS Virginia

DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.

OTHER

Sensor Augmented Pump Therapy

Subjects randomized to this placebo group will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.

Sponsors & Collaborators

Principal Investigators

  • Bruce Buckingham, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147860 on ClinicalTrials.gov