Performance of Continuous Glucose Monitoring Systems at Altitude

NCT01223651 | Terminated

• 1 other identifier: 10/H0505/73
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The effect of altitude on the recognition of hypoglycaemic symptoms.

  One year.

Study Arms (2)

CGMS at sea level.

ACTIVE COMPARATOR

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

Procedure: two step hyperinsulinaemic glucose clamp study.

CGMS reliability at simulated 8000 feet.

ACTIVE COMPARATOR

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.

Procedure: two step hyperinsulinaemic glucose clamp study.

Interventions

two step hyperinsulinaemic glucose clamp study. PROCEDURE

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.

CGMS at sea level.; CGMS reliability at simulated 8000 feet.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

Study Sites (2)

Royal Airforce Base Henlow

Henlow, Bedfordshire, SG16 6DN, United Kingdom

Location

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joseph Begley, Doctor

  Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

GB (2)