Safety and pilot efficacy of a mobile app-based decision support system for exercise in type 1 diabetes

Not Applicable

Recruiting

Conditions: E10
Type 1 diabetes mellitus

Registration Number: DRKS00030738

Lead Sponsor: niversität Bayreuth, Bayreuther Zentrum für Sportwissenschaft (BaySpo)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 11

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

1) Recurrent severe hypoglycaemia (>severe hypoglycaemia during the past 12 months)
2) Hypoglycaemia unawareness
3) Hospitalisation for diabetic ketoacidosis during the previous 12 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in Range (TIR) during exercise in comparison of EASD/ISPAD paper- and app-based group vs. standard of care (superiority; efficacy outcome) <br><br>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) <br><br>

Secondary Outcome Measures

Name	Time	Method
TIR during exercise in comparison of EASD/ISPAD app-based group vs. paper-based group (non-inferiority) <br><br>TBR 1 during exercise in comparison of EASD/ISPAD app-based group vs. paper-based group (non-inferiority) <br><br>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 <br><br>Glycaemic variability (%CV and SD) in comparison of the three groups for the pre-, during and post-exercise condition <br><br>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