Safe Use of New Technologies in Diabetes in Flight

NCT06408558 | Completed FDA Device

• 1 other identifier: FHMS 2022 15
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Atmospheric pressure can influence how the body handles blood glucose. At high elevations, atmospheric pressure decreases. Research shows that both the elevation and the length of stay at that elevation can influence the body's glucose response. The investigators would like to find out if the change in pressure in the cabin environment during a flight affects the body's handling of glucose. Commercial planes usually fly at 40000 feet (12192 m) but the cabin pressure is re-pressurized to 8000 feet (2438 m) with cabin pressure fixed at 560 mmHg. The normal atmospheric pressure at sea level is 760 mmHg. Since the investigators cannot perform the studies in an aeroplane, a hypobaric chamber will be used to set to this low pressure which will reproduce the cabin environment during a commercial flight. The chamber is located at the research and development company, QinetiQ, MOD Boscombe. The objective of this study is to compare the effect of atmospheric pressure on glucose metabolism during simulated flight conditions during fasting and in response to a mixed liquid meal. This will involve attending three visits; visit 1 (screening), visit 2 and visit 4 and two phone visits. The duration of the study is 15 days or 1 month depending on the participant's availability. Visit 1, informed consent and screening, will take place at CEDAR, Royal Surrey County Hospital, Guildford, followed by two visits of the meal test in random order at CEDAR or QintetiQ, Visit 2, will be a meal test performed at 760 mmHg OR at 560mmHg. Visit 4, will be a further meal test at 560 mmHg OR 760 mmHg. The order of the meal test visits at different ambient pressures will be randomised. The two phone visits will take place the day after the meal test days to enquire about the patient's health after the test.

Conditions

Type1 Diabetes

Keywords

Postprandial glucose metabolism

Outcome Measures

Primary Outcomes (5)

• Baseline endogenous glucose production

  Mathematical modelling of the data produced from the isotopic analysis of the samples and glucose concentration (micromol/kg/min)

  Through study completion, within 2 years

• Postprandial endogenous glucose production

  Mathematical modelling of the data produced from the isotopic analysis of the samples and glucose concentration (micromol/kg/min)

  Through study completion, within 2 years

• Baseline postprandial glucose uptake

  Mathematical modelling of the data produced from the isotopic analysis of the samples and glucose concentration (micromol/kg/min)

  -150 minute to 0 minute during visit 2 and visit 4

• Postprandial glucose uptake

  Mathematical modelling of the data produced from the isotopic analysis of the samples and glucose concentration (micromol/kg/min)

  Through study completion, within 2 years

• Meal derived glucose disposal

  Mathematical modelling of the data produced from the isotopic analysis of the samples and glucose concentration (micromol/kg/min)

  Through study completion, within 2 years

Secondary Outcomes (3)

• Insulin concentration

  Through study completion, within 2 years

• Glucose concentration

  Through study completion, within 2 years

• Cortisol concentration

  Through study completion, within 2 years

Other Outcomes (8)

• Weight

  Through study completion, within 2 years

• Height

  Through study completion, within 2 years

• BMI

  Through study completion, within 2 years

Study Arms (2)

Starting Hypobaric

EXPERIMENTAL

Hypobaric to Ground level \& Ground level to Hypobaric

Other: Hypobaric; Other: Ground level

Starting Ground level

EXPERIMENTAL

Ground level to Hypobaric \& Hypobaric to Ground level

Other: Hypobaric; Other: Ground level

Interventions

Hypobaric OTHER

The effects of ambient pressure changes on glucose metabolism will be studied

Also known as: Ambient pressure 560 mmHg

Starting Ground level; Starting Hypobaric

Ground level OTHER

The effects of ambient pressure changes on glucose metabolism will be studied

Also known as: Ambient pressure 760 mmHg

Starting Ground level; Starting Hypobaric

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able in the opinion of the investigator, and willing to give informed consent obtained before any study-related activities.
• Type 1 diabetes
• Duration of type 1 diabetes greater than 12 months.
• Current treatment insulin pump therapy.
• Male or female aged 18 - 65 years.
• BMI of less than 30 kg/m2.
• HbA1c of less than 9%.
• Able and willing to complete the study.
• No cardiovascular complications
• No significant past respiratory disease
• No chronic (long-term) ENT disease such as vertigo, sinusitis or perforated ear drum
• Fitness to undertake long haul airliner flight as a passenger, without assistance or any form of medical support (e.g. supplementary oxygen)
• Patients who are or who have previously been involved in research are eligible provided they have not received an investigational drug within one month of entry into the study

You may not qualify if:

• Outside of stated age range.
• Female who is pregnant, breast feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
• Participation in any clinical trial of an investigational medicinal product within 30 days before screening.
• Inability to understand verbal and / or written explanations given in English.
• Proliferative retinopathy that has required acute treatment within last three months.
• History of severe renal impairment.
• History of unstable or rapidly progressing renal disease.
• History of hepatic insufficiency / and or significant abnormal liver function.
• Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody.
• Congestive heart failure defined as New York Heart Association (NYHA) class III and IV, unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially.
• Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
• Uncontrolled cardiac arrhythmias.
• Uncontrolled hypertension. (BP greater than 160/90).
• Exclude any ENT disease that might interfere with ventilation of the middle ear cavity ('ear clearing') or sinuses
• Any ENT surgery in last 6 months

Sponsors & Collaborators

• University of Surrey: lead
• Medical University of Graz: collaborator
• KU Leuven: collaborator
• UK Civil Aviation Authority: collaborator
• QintetiQ Ltd.: collaborator

Study Sites (1)

David L. Russell-Jones

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (3)

• Fan KS, Shojaee-Moradie F, Manoli A, Baumann PM, Koehler G, Edwards V, Lee V, Mathieu C, Mader JK, Russell-Jones D; EASA Diabetes Consortium. The Feasibility of an Experimental Hypobaric Simulation to Evaluate the Safety of Closed-Loop Insulin Delivery Systems in Flight-Related Atmospheric Pressure Changes. Diabetes Technol Ther. 2025 Feb;27(2):128-133. doi: 10.1089/dia.2024.0380. Epub 2024 Oct 24.

  PMID: 39446977 RESULT

• Fan KS, Manoli A, Shojaee-Moradie F, Hutchison E, Strollo F, Koehler G, Mader JK, Russell-Jones D; EASA Diabetes Consortium. The practical operation and consequences of glucose measurement by pilots with diabetes. Diabet Med. 2025 Mar;42(3):e15472. doi: 10.1111/dme.15472. Epub 2024 Nov 9.

  PMID: 39521725 RESULT

• Garden GL, Fan KS, Paterson M, Shojaee-Moradie F, Borg Inguanez M, Manoli A, Edwards V, Lee V, Frier BM, Hutchison EJ, Maher D, Mathieu C, Mitchell SJ, Heller SR, Roberts GA, Shaw KM, Koehler G, Mader JK, King BR, Russell-Jones DL; EASA Diabetes Consortium. Effects of atmospheric pressure change during flight on insulin pump delivery and glycaemic control of pilots with insulin-treated diabetes: an in vitro simulation and a retrospective observational real-world study. Diabetologia. 2025 Jan;68(1):52-68. doi: 10.1007/s00125-024-06295-1. Epub 2024 Nov 4.

  PMID: 39496965 RESULT

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomised crossover study at two different ambient pressures one at normal ambient pressure (760 mmHg) and the other at 560 mmHg mimicking the repressurised cabin environment at 8000 feet.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 10, 2024
• Study Start: January 28, 2023
• Primary Completion: January 7, 2024
• Study Completion: January 7, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available following the statistical analysis 2/01/2025
• Access Criteria: Once the data is avalible

Locations

GB (1)