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Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

NCT02135068 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-04-20

No results posted yet for this study

Summary

This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.

Conditions

Interventions

DEVICE

Medtronic MiniMed Closed Loop (CL) System

The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.

OTHER

Snacking

Up to 45 g of oral glucose via Gatorade

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Jennifer Sherr, MD, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02135068 on ClinicalTrials.gov