E10
Conditions
Interventions
Group 1: Use of a prototype CGM-based exercise app for time in range around different types of exercise
Group 2: Use of a paper based EASD/ISPAD position statement approach for time in range around di
Sponsors
Universität Bayreuth, Bayreuther Zentrum für Sportwissenschaft (BaySpo)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Adults with T1D (as diagnosed clinically) =12 months 2) Treated with multiple daily insulin injections =12 months 3) Body mass index 18.0-29.9 kg/m2 (both inclusive) 4) Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min 5) HbA1c =10% (86 mmol/mol) 6) Already using rtCGM or isCGM = 3months
Exclusion criteria
Exclusion criteria: 1) Recurrent severe hypoglycaemia (>severe hypoglycaemia during the past 12 months) 2) Hypoglycaemia unawareness 3) Hospitalisation for diabetic ketoacidosis during the previous 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Range (TIR) during exercise in comparison of EASD/ISPAD paper- and app-based group vs. standard of care (superiority; efficacy outcome) Time below range 1 (TBR1; <70 mg/dL) during exercise in comparison of EASD/ISPAD paper- and app-based group vs. standard of care (superiority; safety outcome) | — |
Secondary
| Measure | Time frame |
|---|---|
| TIR during exercise in comparison of EASD/ISPAD app-based group vs. paper-based group (non-inferiority) TBR 1 during exercise in comparison of EASD/ISPAD app-based group vs. paper-based group (non-inferiority) Time above range 2 (TAR; >250 mg/dL), TAR 1 (181-250 mg/dL); TIR, TBR 1 and TBR 2 (<54 mg/dL) in comparison of the three groups for the pre-, during and post-exercise condition Glycaemic variability (%CV and SD) in comparison of the three groups for the pre-, during and post-exercise condition Numbers of events per person of TBR 1 and TBR 2 in comparison of the three groups for the pre-, during and post-exercise condition | — |
Countries
Austria, Germany
Contacts
Public ContactJanis Schierbauer
Universität Bayreuth, Bayreuther Zentrum für Sportwissenschaft (BaySpo)
Outcome results
None listed