Type 1 diabetes mellitus E10
Conditions
Interventions
Group 1: Group 1 (TFIT): track and field exercise and intensified diabetes treatment adjustments
Group 2: Group 2 (IT): intensified diabetes treatment adjustments
no track and field exercise units
Sponsors
Division Exercise Physiology and Metabolism
Eligibility
Sex/Gender
All
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: • Informed consent obtained from participants and parents or a legal guardian • Diagnosis of T1D for at least 1 year • Insulin therapy established either with insulin pen therapy (multiple daily injections) or continuous subcutaneous insulin infusion (pump therapy). In users with automated insulin support via CSII, this feature (AutoMode) has to be deactivated during the whole study duration (manual mode) • Male or female aged 10-17 years (both inclusive) • HbA1c < 12% at screening • Body mass index (BMI) within the 10th (P10) to 90th (P90) percentile of the respective sex and age of children in Germany (both inclusive; percentiles according to RKI)
Exclusion criteria
Exclusion criteria: • Enrolment in another study • Performance of regular club sports (> once per week) which is physically exhausting during the study phase (school sports excluded) • Using of an insulin pump with hybrid/closed loop technology or unwillingness to switch to the manual mode in order to participate in the study • Hypoglycaemic unawareness via gold score • Previous clinical relevant hypoglycaemia or DKA requiring third party help during the last 6 months • Children or adolescents without explicit written consent of their parents or a legal guardian • Known or suspected hypersensitivity to trial product(s) or related products • Receipt of any investigational medicinal product within 1 week prior to screening in this trial • 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 with T1D or patients taking medications that influence 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. Furthermore, it does not exclude patients who have celiac disease (or similar diseases or allergies), as long as the disease is stable and participants do not require specific medication (e.g. cortisone), and patients are able to stay on their specific (e.g.) gluten-free diet • Children who cannot responsibly regulate their blood glucose levels independently (as deemed by the investigator) and whose parents are not present to provide support during physical exercise • Participant with a heart rate <50 beats per minute (bpm) at screening (after resting for 5 min in supine position) • Supine systolic or diastolic blood pressure at screening (after resting for 5 min in supine position) within 95th (P95) percentile or higher of the respective sex, age and height group of children in Germany (hypertension threshold; excluding white-coat hypertension; therefore, if a repeated measurement on a second screening Visit shows values within the range, the participant can be included in the trial)26; 27. This exclusion criterion also pertains to participants being on anti-hypertensives • Significant abnormal ECG at screening, as judged by the Investigator • Any chronic (metabolic) disorder or severe disease (other than T1D) which, in the opinion of the investigator, might jeopardize participant’s safety or compliance with the protocol • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction • Participants with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, are not able to meet the cognitive or language requirements of the study • Potentially non-compliant or uncooperative participants, as judged by the Investigator • Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact on % time in range (%TiR; 3.9-10.0 mmol/L, 70-180 mg/dL) and % time below glucose range 1 (%TbR 1; <3.9 mmol/L, <70 mg/dL) of a 4-week period of intensified regular diabetes specific treatment adjustments with or without intensive track and field units under supervision in children and adolescents with type 1 diabetes assessed by CGM (continuous glucose monitoring; blinded Dexcom G6). The changes in %TiR and %TbR 1 between control phase and the different intervention phases as well as differences between the two different intervention arms are compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Glucose Metrics (via blinded Dexcom G6) comparing the control phase to the different intervention phases and between the two different intervention arms o 24 h post-exercise TiR (%) o 24 h post-exercise TbR 1 (%) o Changes in GMI (%): Interstitial glucose [iG] data are analyzed during the whole 4-week period and split into distinct glycaemic ranges and stratified into day (06:00–23:59) and night (00:00–05:59) time periods and exercise periods. o %TbR2: Percentage of time below range level 2 (10 mmol/L, 180 mg/dL) measured by CGM (exercise facility/at home) o %TaR2: Percentage of time above range level 2 (>13.9 mmol/L, 250 mg/dL) measured by CGM (exercise facility/at home) o Nhypoglycaemia:: Number of hypoglycaemic excursions (sensor glucose = 20min) measured by CGM (exercise facility/at home) o Glucose%CV: Glucose variability assessed by %Coefficient of Variation (%CV), Mean Absolute Glucose (MAG) and Low Blood Glucose Index (LBGI) measured by CGM (exercise facility/at home) o GlucoseIndicator: Glucose Management Indicator (GMI) measured by CGM (exercise facility/at home) o Basal insulin per day (units, IU/kg; %) o Bolus insulin per day (units, IU/kg; %) o Total amount of insulin per day (units, IU/kg; %) o To assess number and amount of insulin corrections o 2 h post-prandial glucose excursion (mmol/L; mg/dL) o Carbohydrate intake per day (g) o To assess carbohydrate to insulin ratio • Blood parameters via venous blood samples from the antecubital vein comparing the control phase to the different intervention phases and between the two different intervention arms. (esp. hormonal and T1D specific markers; assessed at Screening as well as before and after the respective intervention phases): o Differential blood count o HbA1c (%) o C-peptide (µg/L) o hsCRP : High sensitive C-reactive protein (mg/L) o CK: Creatine kinase (IU/L) o hsTroponin (µg/L) o metabolomic markers (targeted) o metabolomic disease patterns (untargeted) • Cardio-respira | — |
Countries
Austria, Germany
Contacts
Public ContactRebecca Zimmer
Division Exercise Physiology and Metabolism, University of Bayreuth
Outcome results
None listed