Type 1 Diabetes Mellitus
Conditions
Interventions
Group 1: 20 otherwise healthy volunteers with type 1 diabetes, experienced in use of an automated insulin delivery (AID) system
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Signed informed 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 according to the WHO definition at screening. • HbA1c =8.0% (=64 mmol/mol) at screening • TIR >70% in the last 2 weeks prior to screening • AID use >90% in the last 2 weeks prior to screening • Participant has experience infusing rapid-acting insulin analogue, total daily insulin dose 12 months after screening date) • Citizen of an EU country or Switzerland/Norway/Iceland • Willingness to comply with all regulations according to aviation safety/air travel
Exclusion criteria
Exclusion criteria: • Participants currently participating in an investigational clinical study that interferes with execution of the study • Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator. • Current treatment with non-insulin hypoglycaemic agents • Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator. • Diabetic ketoacidosis during the previous 6 months • Severe hypoglycaemia requiring third party assistance, hospitalization or emergency room visit during the previous 12 months. • Hypoglycaemia unawareness • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. • Skin pathology or conditions prohibiting needle insertion/insulin administration as judged by the investigator. • Medically documented allergy towards the adhesive of plasters or participant is unable to tolerate tape adhesive in the area of sensor placement. • History of bleeding disorder • Severe visual or hearing impairment • Poor treatment compliance • Difficulty in walking • Fear of flying • History of air sickness and/or motion sickness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall time in range (TIR 70-180mg/dl) assessed via CGM during in-flight vs. on ground conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall time in range (TIR 70-180mg/dl) assessed via CGM during in-flight vs. on ground conditions (fasting and non-fasting conditions combined). Time in range (TIR 70-180mg/dl) assessed via CGM during fasting in-flight vs. on ground conditions. Time in range (TIR 70-180mg/dl) assessed via CGM during non-fasting in-flight vs. on ground conditions. In-flight time in range (TIR 70-180mg/dl) assessed via CGM during fasting vs. non-fasting conditions. Time in range (TIR 70-180mg/dl) assessed via CGM during ascent, descent and at cruising altitude. Time in tight range (TITR 70-140mg/dl) assessed via CGM during in-flight vs. ground conditions (fasting and non-fasting conditions combined). Time in tight range (TITR 70-140mg/dl) assessed via CGM during fasting in-flight vs. on ground conditions. Time in tight range (TITR 70-140mg/dl) assessed via CGM during non-fasting in-flight vs. ground conditions. In-flight time in tight range (TIR 70-140mg/dl) assessed via CGM during fasting vs. non-fasting conditions. Time in tight range (TITR 70-140mg/dl) assessed via CGM during ascent, descent and at cruising altitude. Overall time below range 1 (TBR1 180mg/dl) assessed via CGM during in-flight vs. on ground conditions. Time above range 1 (TAR1 >180mg/dl) assessed via CGM during fasting in-flight vs. on ground conditions. Time above range 1 (TAR1 >180mg/dl) assessed via CGM during non-fasting in-flight vs. on ground conditions. In-flight time above range 1 (TAR1 >180mg/dl) assessed via CGM during fasting vs. non-fasting conditions. Time above range 1 (TAR1 > 180mg/dl) assessed via CGM during ascent, descent and at cruising altitude. Overall time above range 2 (TAR2 >250mg/dl) assessed via CGM during in-flight vs. on ground conditions. Time above range 2 (TAR2 >250mg/dl) assessed via CGM during fasting in-flight vs. on ground conditions. Time above range 2 (TAR2 >250mg/dl) assessed via CGM during non-fasting in-flight vs. on ground conditions. In-flight tim | — |
Countries
Austria, Germany
Contacts
Public ContactJulia Mader
Medizinische Universität Graz
Outcome results
None listed