Skip to content

Performance of Continuous Glucose Monitoring Systems at Altitude

Performance of Continuous Glucose Monitoring Systems at Altitude.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01223651
Enrollment
10
Registered
2010-10-19
Start date
2012-01-31
Completion date
2013-03-31
Last updated
2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1, Continuous Glucose Monitoring System, Accuracy, Altitude

Brief 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.

Interventions

PROCEDUREtwo 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

The Royal Bournemouth Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18 - 60 years. * No known medical conditions or concomitant medication.

Exclusion criteria

* Pregnancy. * Marine diving in preceding 24 hours. * Unable to provide written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of continuous glucose monitoring system (CGMS).One year.To evaluate the accuracy of CGMS for glucose measurement at altitude (8,000 ft) in healthy volunteers.

Secondary

MeasureTime frameDescription
The effect of altitude on the recognition of hypoglycaemic symptoms.One year.To examine the effect of high altitude (8,000 ft) on the recognition of hypoglycaemia in healthy volunteers.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026