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Three-way, Cross-over Closed-loop Exercise Study

NCT02241889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-05-22

Study results available
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Summary

Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar are paving the way to revolutionize the management of this disease. The benefit of improved control of blood sugar levels compared to standard insulin pump therapy has already been demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably during exercise. The investigators research group has shown that small doses of glucagon can prevent low blood sugar when used in a blood sugar control system in patients with type 1 diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the ability to recognize the onset of physical activity in order to appropriately adjust the insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia.

The purpose of this study is to test how well a new modified blood sugar control system controls blood sugar during exercise compared to: 1) the current system without modifications and 2) standard insulin pump therapy.

Conditions

Interventions

DEVICE

Insulin pump therapy

Subject's own insulin pump will be used to manage blood glucose.

DEVICE

Closed-loop Artificial Pancreas Controller

Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jessica Castle, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

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 NCT02241889 on ClinicalTrials.gov