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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1255-5564 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® & Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels.
Participants will use Tresiba® & Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor.
NovoPen® 6 is a smart pen, which collects and stores the date and time of injections and number of units of insulin participants have taken.
NovoPen® 6 can transfer participants insulin dosing information to the mobile application, which participants use to see their continuous blood sugar level. This will allow participants to see their insulin doses along with continuous blood sugar level in the mobile application.
Participants will keep using their own continuous blood sugar monitoring device and the mobile application to see these data during the study.
The study will last for about 9-11 months. Participants will be asked to complete 2 questionnaires in this study. One questionnaire is about overall satisfaction of using a digital health solution and other is about quality of life. Participants will complete these questionnaires during their normally scheduled visit with the study doctor, on 2 separate occasions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tresiba + Fiasp using NovoPen 6 per local label | Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec | Drug | Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will use Tresiba® and Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imeldaziekenhuis - Bonheiden - Department of Endocrinology | Bonheiden | 2820 | Belgium | |||
| HUB - Hôpital Erasme |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| Fast-acting insulin aspart | Drug | Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp® |
|
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) |
| Brussels |
| 1070 |
| Belgium |
| Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie | Brussels | 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 |
| Bispebjerg Hospital, IC-Forskning | Copenhagen | 2400 | Denmark |
| Medicinsk Afdeling B, Herning Centralsygehus | Herning | 7400 | Denmark |
| Regionshospitalet Silkeborg - Endokrinologisk afd. | Silkeborg | 8600 | Denmark |
| Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre | 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 | 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 | Vandœuvre-lès-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 |
| Medicinmottagning1 Universitetssjukhuset Örebro | Örebro | 701 85 | Sweden |
| Centrum for Diabetes, Academical Specialist Centrum | Stockholm | 113 65 | Sweden |
| Medicinkliniken Sundsv | Sundsvall | 851 86 | Sweden |
| Uppsala universitetssjukhus | Uppsala | 751 85 | Sweden |
| Frölunda Specialistsjukhus | Västra Frölunda | 42144 | Sweden |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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