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Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study

NCT01973413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-04-24

Study results available
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Summary

The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Diabetes Assistant (DiAs)

The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range.

DEVICE

Tandem t:slim Insulin Pump

FDA, market-approved insulin pump.

DEVICE

Dexcom G4 Platinum sensor

FDA, market-approved continuous glucose monitor (CGM)

Sponsors & Collaborators

Principal Investigators

  • Bruce Buckingham, MD · Stanford University

  • Marc Breton, PhD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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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 NCT01973413 on ClinicalTrials.gov