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Suspended awaiting Ministry of Defence ethics approval.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Begley, Doctor | Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Airforce Base Henlow | Henlow | Bedfordshire | SG16 6DN | United Kingdom | ||
| Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Bournemouth |
| Dorset |
| BH7 7DW |
| United Kingdom |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |