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Performance of Continuous Glucose Monitoring Systems at Altitude

NCT01223651 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-09-07

No results posted yet for this study

Summary

10 healthy volunteers will undergo the controlled lowering of their blood glucose level at sea level and a simulated altitude of 8,000 feet, to test the hypothesis that continuous glucose monitoring system measurement of blood glucose is as accurate at altitude as at sea level.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

PROCEDURE

two step hyperinsulinaemic glucose clamp study.

Study participants will have their blood glucose stabilized between 5 - 6 mmol/L by the delivering of a controlled rate insulin/glucose infusion. Participants will have their blood glucose level reduced by conducting a controlled two step hyperinsulinaemic glucose clamp. The clamp procedure will take a total of 120 minutes and will reduce the blood glucose level to below 3 mmol/L. During this time blood tests will be obtained for analysis, physical observations recorded and cognitive function tests performed at regular intervals. Participants will have been fitted at least 12 hours prior to the intervention with 2 real time continuous glucose monitoring systems which will remain in place for the duration of the clamp procedure, however participants will be blinded to their glucose readings.

Sponsors & Collaborators

  • The Royal Bournemouth Hospital

    lead OTHER

Principal Investigators

  • Joseph Begley, Doctor · Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United Kingdom

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 NCT01223651 on ClinicalTrials.gov