| Outcome Measures: |
Primary: Change in time in range (3.9-10 mmol/L), Percentage change (absolute) (Using available rtCGM (Real-Time Continuous Glucose Monitoring) and isCGM data(Intermittent-scanning Continuous Glucose Monitoring)), Baseline (Day -14 to Day 0) to End of Study (Day 280) | Secondary: Change in time in hyperglycaemia/above range Level 1 (10.1 - 13.9 mmol/L), Percentage change (absolute) (Using available rtCGM and isCGM data), Baseline (Day -14 to Day 0) to End of Study (Day 280)|Change in time in hyperglycaemia/above range Level 2 (greater than 13.9 mmol/L), Percentage change (absolute) (Using available rtCGM and isCGM data), Baseline (Day -14 to Day 0) to End of Study (Day 280)|Change in time in hypoglycaemia/below range Level 1 (3.0-3.8 mmol/L), Percentage change (absolute) (Using available rtCGM and isCGM data), Baseline (Day -14 to Day 0) to End of Study (Day 280)|Change in time in hypoglycaemia/below range Level 2 (below 3.0 mmol/L), Percentage change (absolute) (Using available rtCGM and isCGM data), Baseline (Day -14 to Day 0) to End of Study (Day 280)|Change in mean glucose, mmol/L (Using available rtCGM and isCGM data), Baseline (Day -14 to Day 0) to End of Study (Day 280)|Change in glucose variability (% coefficient of variability), Percentage change (absolute) (Using available rtCGM and isCGM data), Baseline (Day -14 to Day 0) to End of Study (Day 280)|Change in Glucose Management Indicator, Percentage change (absolute) (Using available rtCGM and isCGM data) (4The GMI is calculated from mean glucose as GMI (%) = 3.31 + 0.4306 \[mean glucose mmol/L\]), Baseline (Day -14 to Day 0) to End of Study (Day 280)|Change in HbA1c (Glycated haemoglobin), Percentage change (absolute) (Using HbA1c results based on blood tests), Baseline (Week 0) to End of Study (Week 40)|T1-DDS (Diabetes Distress Scale for Adults with Type1 Diabetes), change in QoL (Quality of Life), Change (absolute) (Using T1-DDS questionnaire data), Baseline (Week 0) to End of Study (Week 40)|DHSS (Digital Health Solution Satisfaction)-Patient, Total score (Using DHSS questionnaire for patient \& HCP respectively), End of Study (Week 40)|DHSS-HCP(Health Care Professional), Total score (Using DHSS questionnaire for patient \& HCP respectively), End of Study (Week 40)
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| Locations: |
Imeldaziekenhuis - Bonheiden - Department of Endocrinology, Bonheiden, 2820, Belgium|HUB - Hôpital Erasme, Bruxelles, 1070, Belgium|Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie, Bruxelles, 1200, Belgium|UZA - UZ Antwerpen - Department of Endocrinology, Edegem, 2650, Belgium|UZ Leuven - Endocrinology, Leuven, 3000, Belgium|Centre Hospitalier Universitaire de Liège, Liège, 4000, Belgium|Aarhus Universitetshospital Diabetes og Hormonsygdomme, Aarhus N, 8200, Denmark|Medicinsk Afdeling B, Herning Centralsygehus, Herning, 7400, Denmark|Bispebjerg Hospital, IC-Forskning, København, 2400, Denmark|Endokrinologisk afd, Regions Hospitalet Silkeborg, Silkeborg, 8600, Denmark|Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1, Caen, 14033, France|Centre Hospitalier Sud Francilien, Corbeil Essonnes, 91106, France|hôpital Saint Joseph Saint Luc, Lyon, 69365, France|Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie, MONTPELLIER cedex 5, 34295, France|Ap-Hp-Hopital Bichat-Claude Bernard-1, Paris, 75877, France|Hospices Civils de Lyon-Hopital Lyon Sud-2, Pierre-Bénite, 69495, France|Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2, Toulouse, 31054, France|Chru de Nancy - Hopital Brabois, Vandoeuvre Les Nancy, 54511, France|Diabetesmottagningen, Medicinkliniken, Södra Älvsborgs Sjukhus, Borås, 501 82, Sweden|Diabetesmottagningen, Södra Älvsborgs Sjukhus, Borås, 501 82, Sweden|Endokrinologiska kliniken, Malmö, Malmö, 205 02, Sweden|Centrum for Diabetes, Academical Specialist Centrum, Stockholm, 113 65, Sweden|Medicinkliniken Sundsv, Sundsvall, 851 86, Sweden|Akademiska sjukhuset Uppsala, Uppsala, 751 85, Sweden|Frölunda Specialistsjukhus, Västra Frölunda, 42144, Sweden|Medicinmottagning1 Universitetssjukhuset Örebro, Örebro, 701 85, Sweden
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