E10
Conditions
Interventions
Group 1: Use of the automated mode of the pump (ease-off mode of the pump and setting the glucose target value to 120 mg/dL)
Group 2: Use of the manual mode of the pump and reduction of the basal insu
Sponsors
Universität Bayreuth, Bayreuther Zentrum für Sportwissenschaft (BaySpo)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Informed consent obtained - Male or female aged 18–70 years (both inclusive) - Diagnosed with type 1 diabetes mellitus (>12 months) - HbA1c =10% (86 mmol/mol) - Use of the mylife CamAPS FX system or willing to be switched to the mylife CamAPS FX system over the duration of the study
Exclusion criteria
Exclusion criteria: - Recurrent severe hypoglycemia (severe hypoglycemia with loss of consciousness during the past 6 months) - Hypoglycaemia unawareness as assessed by Gold Score (=4) - Hospitalization for diabetic ketoacidosis during the previous 6 months - females who are pregnant as tested via pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - t70-180: Time in range (%TiR; 70-180 mg/dL) during hypertrophy resistance training in comparison of trial arms (efficacy outcome) - tn<70: Total number of hypoglycemia (nTbR; <70 mg/dL for =5 min) during hypertrophy resistance training | — |
Secondary
| Measure | Time frame |
|---|---|
| -n180: Time above range 1 (%TaR1; >180 mg/dL), including readings of >250 mg/dL during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - t>250: Time above range 2 (%TaR2; >250 mg/dL) during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - CV: Coefficient of variation (%) during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - SD: Standard deviation of mean glucose during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - meanglu: mean sensor glucose (mg/dL) during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - t70-140: Time in tight range (%TiTR; 70–140 mg/dL) during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - eventrate>250: Extended hyperglycaemic event rate (nTaR; >250 mg/dL; for =5 min) during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) (nTaR; >250 mg/dL; for =15 min) in comparison of trial arms - prop70-180: Proportion of participants with time in range (TiR; 70–180 mg/dL) for >70% during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - prop180: Proportion of participants with time above range 1 (TaR1; >180 mg/dL) for 270: Proportion of participants with time above range 2 (TaR2; 70% time in range 70–180 mg/dL and 70% time in range (TiR; 70–180 mg/dL) and <1% time below range 2 (TbR2; <54 mg/dL) during hypertrophy resistance training and during the 24h post-exercise period (day vs. nighttime) in comparison of trial arms - glunadir: Glucose nadir (mg/dL) during hypertrophy resistance training in comp | — |
Countries
Germany
Contacts
Public ContactOthmar Moser
Universität Bayreuth, Bayreuther Zentrum für Sportwissenschaft (BaySpo)
Outcome results
None listed