Diabetes Mellitus, Type 1NCT01223651
Performance of Continuous Glucose Monitoring Systems at Altitude
A study testing two step hyperinsulinaemic glucose clamp study. in people with Diabetes Mellitus, Type 1, run by The Royal Bournemouth Hospital at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- two step hyperinsulinaemic glucose clamp study.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 60 years.
- No known medical conditions or concomitant medication.
Who cannot join
- Pregnancy.
- Marine diving in preceding 24 hours.
- Unable to provide written informed consent.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW
Royal Airforce Base Henlow
Henlow, Bedfordshire, SG16 6DN
About this study
Official title: Performance of Continuous Glucose Monitoring Systems at Altitude.
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
- Being tested
- two step hyperinsulinaemic glucose clamp study.
- Keywords
- Diabetes Mellitus, Type 1, Continuous Glucose Monitoring System, Accuracy, Altitude
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two step hyperinsulinaemic glucose clamp study.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: two step hyperinsulinaemic glucose clamp study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of continuous glucose monitoring system (CGMS).
To evaluate the accuracy of CGMS for glucose measurement at altitude (8,000 ft) in healthy volunteers.
Measured: One year.
Secondary outcomes (1)
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.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Suspended awaiting Ministry of Defence ethics approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Begley, Doctor, Principal investigator, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223651
- Sponsor's protocol ID
- 10/H0505/73
- Status last verified
- Sep 2018
- First submitted
- 18 Oct 2010
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Continuous Glucose Monitoring Systems at Altitude.
- ClinicalTrials.gov ID
- NCT01223651
- Acronym / sponsor ID
- 10/H0505/73
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Continuous Glucose Monitoring System, Accuracy, Altitude
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended awaiting Ministry of Defence ethics approval.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGMS at sea level. | Active comparator | Procedure: two step hyperinsulinaemic glucose clamp study.To assess reliability of continuous glucose monitoring system at sea level whilst subject undergo's a hyperinsulinaemic glucose clamp study. |
| CGMS reliability at simulated 8000 feet. | Active comparator | Procedure: two step 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 - 60 years.
- No known medical conditions or concomitant medication.
Key exclusion criteria (3 listed)
- Pregnancy.
- Marine diving in preceding 24 hours.
- Unable to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | CGMS at sea level., CGMS reliability at simulated 8000 feet. |
Primary outcome
Accuracy of continuous glucose monitoring system (CGMS).
Time frame: One year.
To evaluate the accuracy of CGMS for glucose measurement at altitude (8,000 ft) in healthy volunteers.
1 secondary outcome
The effect of altitude on the recognition of hypoglycaemic symptoms.
Time frame: One year.
Results and safety
The study was stopped early (reason given: Suspended awaiting Ministry of Defence ethics approval.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Begley, Doctor principal investigator
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two step hyperinsulinaemic glucose clamp study. in people with Diabetes Mellitus, Type 1, run by The Royal Bournemouth Hospital at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Suspended awaiting Ministry of Defence ethics approval.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of continuous glucose monitoring system (CGMS). (time frame: One year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.