Performance of Continuous Glucose Monitoring Systems at Altitude

The Royal Bournemouth Hospital

Status: Terminated

Conditions: Diabetes Mellitus, Type 1

Treatments: Procedure: two step hyperinsulinaemic glucose clamp study.

Study type: Interventional

Funder types: Other

Identifiers

NCT01223651

10/H0505/73

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

CGMS at sea level.

Active Comparator group

Description:

To assess reliability of continuous glucose monitoring system at sea level whilst subject undergo's a hyperinsulinaemic glucose clamp study.

Treatment:

Procedure: two step hyperinsulinaemic glucose clamp study.

CGMS reliability at simulated 8000 feet.

Active Comparator group

Description:

To assess reliability of continuous glucose monitoring system at a simulated altitude of 8,000 feet whilst the participant undergo's a hyperinsulinaemic glucose clamp study.

Treatment:

Procedure: two step hyperinsulinaemic glucose clamp study.