HEALTHY VOLUNTEERS
Conditions
Interventions
Group 1: Continuous aerobic exercise at moderate intensity to detect the accuracy of the “Supersapiens” Abbott Libre Sense in comparison to the Biosen S-Line and Dexcom G6
Group 2: High-intensity inte
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Informed consent obtained - Body mass index 18.0–29.9 kg/m2 (both inclusive) - Normal glucose tolerance (measured via fasting blood glucose levels) - Participants performing regular physical activity during the last 3 months prior to screening - Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min
Exclusion criteria
Exclusion criteria: - Enrolment in other study - 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 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. Furthermore, it does not excluded patients how have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten-free diet. - Participant with a heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position) - Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic (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). 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 which, in the opinion of the Investigator might jeopardise 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 - 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 - Potentially non-compliant or uncooperative during the trial, 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 sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean absolute relative difference (%MARD) between Supersapiens Abbott Libre Sense device and reference capillary blood glucose during exercise (Biosen S-Line system EKF Diagnostic, GER) | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Accuracy metrics - %MARDexercise: % of MARD around exercise in Supersapiens Abbott Libre Sense compared to capillary blood glucose (home phase) - MARDrest: % of MARD during resting conditions of Supersapiens Abbott Libre Sense compared to capillary blood glucose (home phase) - %MARDLowGluc: of Supersapiens Abbott Libre Sense for reference values between 3.0 and 5.6mmol/L (55 to 100mg/dL) compared to Biosen S-Line system EKF Diagnostic (lab phase) and glucometer (home phase) - %MARDEuGlucc: of Supersapiens Abbott Libre Sense for reference values between 5.6mmol/L and 7.8mmol/L (100 to 140mg/dL) compared to Biosen S-Line system EKF Diagnostic (lab phase) and glucometer (home phase) - %MARDHighGluc: of Supersapiens Abbott Libre Sense for reference values between 5.6mmol/L and 7.8mmol/L (>140 mg/dL) compared to Biosen S-Line system EKF Diagnostic (lab phase) and glucometer (home phase) b. Glucose Metrics - %timehypoglycaemia2: Percentage of time spent in hypoglycaemia (10mmol/L, 180mg/dL) measured by Dexcom G6 (lab/home phase) - Nhypoglycaemia: Number hypoglycaemic excursions (sensor glucose = 20min) measured by Dexcom G6 (lab/home phase) - Glucose%CV: Glucose variability assessed by %Coefficient of Variation (%CV), Mean Absolute Glucose (MAG) and Low Blood Glucose Index (LBGI) measured by Dexcom G6 (lab/home phase) - GlucoseIndicator: Glucose Management Indicator (GMI) measured by Dexcom G6 (lab/home phase) c) Sensor metrics - %timeuse: Time in % in use for Supersapiens Abbott Libre Sense (home phase) - Nfailure: Number/Rate of sensor failure rate for all sensoric devices (home phase) d) Exploratory endpoints - To assess pain during after sensor placement (Visual Analogue Scale) - To assess skin reactions (e.g. irritation, rash or edema) via Draize Score - StressHRV: Stress induced post-exercise and assessed via glucose excursions and heart rate variability within 24h post-exercise. | — |
Countries
Germany, United Kingdom
Contacts
Public ContactOthmar Moser
Division Exercise Physiology and MetabolismInstitute of Sport ScienceUniversity of Bayreuth, GER
Outcome results
None listed