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Medtronic Minimed Overnight Closed-Loop System

NCT01881009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-11-14

Study results available
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Summary

To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will move the study to an outpatient diabetes camp setting. The camp setting will allow us to obtain pilot efficacy and safety data in a "real-life" environment.

We plan to compare the subject control nights to the subject nights on the OCL system to assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on previous research, we anticipate that the use of the OCL system will contribute to a greater percentage of sensor glucose readings in the target range.

Conditions

  • Type 1 Diabetes Mellitus
  • Autoimmune Diabetes
  • Juvenile-Onset Diabetes
  • Diabetes, Mellitus, Type 1

Interventions

DEVICE

Hybrid Closed-loop System

Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter, PID-IFB (proportional-integral-derivative based with insulin feedback) algorithm on an Android platform with remote monitoring.

DEVICE

Sensor-augmented pump

Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter.

Sponsors & Collaborators

  • Bruce A. Buckingham

    lead OTHER

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
2013-06-30
Primary Completion
2013-08-03
Completion
2013-08-03

Countries

  • United States

Study Locations

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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 NCT01881009 on ClinicalTrials.gov