Safety and efficacy of automated insulin delivery systems and sensor-augmented pumps during commercial airplane flights – a prospective observational study

Safety and efficacy of automated insulin delivery systems and sensor-augmented pumps during commercial airplane flights – a prospective observational study - FLIGHT-PUMP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040888

Enrollment

Registered

2026-07-09

Start date

2025-02-24

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10

Interventions

Group 1: Persons with type 1 diabetes on an automatic insulin delivery (AID) system or sensor augmented pump (SAP) therapy that is planning for a commercial airplane flight within 24 months from stud

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Signed informed electronic consent after being advised of the nature of the study and mental capability to understand the informed consent. - Male or female =18 years of age at the time of signing the informed consent. - Diagnosed with T1D for at least 12 months. - Being treated with AID system or SAP therapy. - Citizen of an EU country or Switzerland/Norway/Iceland speaking either English, Danish, German, French, Italian, or Spanish.

Exclusion criteria

Exclusion criteria: - Treatment in the prospective period of interest with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Time in range (TIR) 3.9–10.0 mmol/l [70–180mg/dl] assessed via CGM during in-flight vs. a 14-day period of on-ground conditions (fasting and non-fasting conditions combined and separately)	—

Secondary

Measure	Time frame
We assess the following outcomes during in-flight vs. on-ground conditions and during ascent, descent and at cruising altitude vs. on ground conditions (fasting and non-fasting conditions combined and separately): - Time in range (TIR 3.9–10.0 mmol/l [70–180mg/dl]) - Time in tight range (TITR 3.9–5.6 mmol/l [70–140mg/dl]) - Three levels of time above range (TAR) 10·0–13·9 mmol/l [181–250 mg/dl], >13·9 mmol/l [>250 mg/dl], and >10·0 mmol/l [>180 mg/dl] - Standard deviation of the glucose distribution - Coefficient of variation - Mean glucose levels - Glycaemia risk index The following outcomes are assessed during in-flight vs. on-ground conditions (fasting and non-fasting conditions combined and separately): - Three levels of time below range (TBR) 3.0–3.9 mmol/l [54–69 mg/dl], <3.0 mmol/l [<54 mg/dl], and <3.9 mmol/l [<70 mg/dl] - Three levels of hypoglycaemic events (standardized to per 24h), 3.0–3.9 mmol/l [54–69 mg/dl], <3.0 mmol/l [<54 mg/dl], and <3.9 mmol/l [<70 mg/dl] - Number of pump failure events during in-flight (standardized to per 24h) vs. on ground conditions. - Number of CGM failure events during in-flight vs. on ground conditions. - Overall total insulin dose (standardized to per 24h) - Overall total basal insulin dose (standardized to per 24h) - Overall total bolus insulin dose (standardized to per 24h) - Overall total correction insulin dose (standardized to per 24h)	—

Measure

Time frame

We assess the following outcomes during in-flight vs. on-ground conditions and during ascent, descent and at cruising altitude vs. on ground conditions (fasting and non-fasting conditions combined and separately): - Time in range (TIR 3.9–10.0 mmol/l [70–180mg/dl]) - Time in tight range (TITR 3.9–5.6 mmol/l [70–140mg/dl]) - Three levels of time above range (TAR) 10·0–13·9 mmol/l [181–250 mg/dl], >13·9 mmol/l [>250 mg/dl], and >10·0 mmol/l [>180 mg/dl] - Standard deviation of the glucose distribution - Coefficient of variation - Mean glucose levels - Glycaemia risk index The following outcomes are assessed during in-flight vs. on-ground conditions (fasting and non-fasting conditions combined and separately): - Three levels of time below range (TBR) 3.0–3.9 mmol/l [54–69 mg/dl], <3.0 mmol/l [<54 mg/dl], and <3.9 mmol/l [<70 mg/dl] - Three levels of hypoglycaemic events (standardized to per 24h), 3.0–3.9 mmol/l [54–69 mg/dl], <3.0 mmol/l [<54 mg/dl], and <3.9 mmol/l [<70 mg/dl] - Number of pump failure events during in-flight (standardized to per 24h) vs. on ground conditions. - Number of CGM failure events during in-flight vs. on ground conditions. - Overall total insulin dose (standardized to per 24h) - Overall total basal insulin dose (standardized to per 24h) - Overall total bolus insulin dose (standardized to per 24h) - Overall total correction insulin dose (standardized to per 24h)

—

Countries

Austria, Denmark

Contacts

Public ContactOmaima El Hakouni

Medizinische Universita¨t Graz, Universita¨tsklinik für Innere Medizin, Klinische Abteilung für Endokrinologie und Diabetologie

omaima.el-hakouni@medunigraz.at+43 67762869735

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026