E10
Conditions
Interventions
Group 1: Pooled exercise intervention groups (5 x 15 min/week- “prime-time” workouts and standard 3 x 50 min/week moderate exercise for 4 weeks)
During the study, several assessments and procedures a
Sponsors
Universität Bayreuth, Deutschland
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Informed consent obtained - Male or female aged 18–64 years (both inclusive) - Diagnosed with type 1 diabetes mellitus (>12 months) - GMI =10% (86 mmol/mol) according to their own CGM device (90 days retrospective) - Use of the mylife CamAPS FX System - CGM and insulin data available over the last 30 days prior to the start of the trial
Exclusion criteria
Exclusion criteria: - Recurrent severe hypoglycaemia (severe hypoglycaemia with loss of consciousness during the past 6 months) - Hypoglycaemia unawareness as assessed by Gold Score (=4) - Females who are pregnant - Hypertension (=140 mmHg systolic and/or = 90 mmHg diastolic) - Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the investigator. This does not prohibit the participation of patients taking medications that influences the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. - Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial - Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare time in range (%TIR; 70–180 mg/dL) of the pooled exercise intervention groups versus the control group (pre/post intervention) (This parameter is reported via data exports and end devices (CGM systems) and indicates the percentage of glucose readings within the target glucose range) | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare the time below range (%TBR, 180 mg/dL) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare the total number of hypoglycaemia (nTbR; 180 mg/dL), including readings of >250 mg/dL of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare time above range 2 (%TaR2; >250 mg/dL) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare the coefficient of variation (%) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare the standard deviation of mean of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare mean sensor glucose (meanglu; mg/dL) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare time in tight range (%TiTR; 70–140 mg/dL) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare the extended hyperglycaemic event rate (nTaR; >250 mg/dL; for =5 min) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare the proportion of participants with time in range (TiR; 70–180 mg/dL) for >70% of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare the proportion of participants with time below range 1 (TbR1180 mg/dL) for 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) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare glucose nadir (mg/dL) of the pooled exercise intervention groups versus the control group (pre/post intervention) - To compare results in International Physical Activity Questionnaire (IPAQ), quality of life (WHOQoL) and Diabetes Quality of Life (DQOL) of the | — |
Countries
Austria, Germany
Contacts
Public ContactOthmar Moser
Universität Bayreuth
Outcome results
None listed