Performance of Continuous Glucose Monitoring Systems at Altitude

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Performance of Continuous Glucose Monitoring Systems at Altitude.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01223651
• Other study ID #: 10/H0505/73
• Status: Terminated
• Phase: N/A
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2018
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust	Bournemouth	Dorset
United Kingdom	Royal Airforce Base Henlow	Henlow	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of continuous glucose monitoring system (CGMS).	To evaluate the accuracy of CGMS for glucose measurement at altitude (8,000 ft) in healthy volunteers.	One year.
Secondary	The effect of altitude on the recognition of hypoglycaemic symptoms.	To examine the effect of high altitude (8,000 ft) on the recognition of hypoglycaemia in healthy volunteers.	One year.