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Performance of Continuous Glucose Monitoring Systems at Altitude

Primary Purpose

Diabetes Mellitus, Type 1

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
two step hyperinsulinaemic glucose clamp study.
Sponsored by
The Royal Bournemouth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Continuous Glucose Monitoring System, Accuracy, Altitude

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Royal Airforce Base Henlow
  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CGMS at sea level.

CGMS reliability at simulated 8000 feet.

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2010
Last Updated
September 5, 2018
Sponsor
The Royal Bournemouth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01223651
Brief Title
Performance of Continuous Glucose Monitoring Systems at Altitude
Official Title
Performance of Continuous Glucose Monitoring Systems at Altitude.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Suspended awaiting Ministry of Defence ethics approval.
Study Start Date
January 2012 (Actual)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Bournemouth Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Type 1, Continuous Glucose Monitoring System, Accuracy, Altitude

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CGMS at sea level.
Arm Type
Active Comparator
Arm Description
To assess reliability of continuous glucose monitoring system at sea level whilst subject undergo's a hyperinsulinaemic glucose clamp study.
Arm Title
CGMS reliability at simulated 8000 feet.
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
two step hyperinsulinaemic glucose clamp study.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy of continuous glucose monitoring system (CGMS).
Description
To evaluate the accuracy of CGMS for glucose measurement at altitude (8,000 ft) in healthy volunteers.
Time Frame
One year.
Secondary Outcome Measure Information:
Title
The effect of altitude on the recognition of hypoglycaemic symptoms.
Description
To examine the effect of high altitude (8,000 ft) on the recognition of hypoglycaemia in healthy volunteers.
Time Frame
One year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Begley, Doctor
Organizational Affiliation
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Airforce Base Henlow
City
Henlow
State/Province
Bedfordshire
ZIP/Postal Code
SG16 6DN
Country
United Kingdom
Facility Name
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom

12. IPD Sharing Statement

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Performance of Continuous Glucose Monitoring Systems at Altitude

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