IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT05069545 (CONNECT 1) para Diabetes mellitus tipo 1 está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Voltar à pesquisa
Novo NordiskA Research Study Looking at How the Use of NovoPen® 6 for Treatment With Tresiba® & Fiasp® Affects the Blood Sugar Level in Patients With Type 1 Diabetes as Part of Local Clinical Practice (CONNECT 1) 411 Saúde digital App móvel
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT05069545 (CONNECT 1) foi um estudo observacional para Diabetes mellitus tipo 1. Seu status atual é: concluído. O estudo começou em 11 de outubro de 2021 e incluiu 411 participantes. Coordenado por Novo Nordisk e foi concluído em 10 de setembro de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 31 de dezembro de 2025.
Resumo
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 inj...
Mostrar maisTítulo oficial
A Multi-centre Prospective Non-interventional Clinical Investigation Studying the Glycaemic Control in Patients With Type 1 Diabetes When Introducing a NovoPen® 6 for Treatment With Tresiba® (Insulin Degludec) & Fiasp® (Fast-acting Insulin Aspart) in a Real-world Setting
Condições médicas
Diabetes mellitus tipo 1Outros IDs do estudo
- CONNECT 1
- DV3325-4759
- U1111-1255-5564 (Outro identificador) (World Health Organization (WHO))
Número NCT
Data de início (real)
2021-10-11
Última atualização postada
2025-12-31
Data de conclusão (estimada)
2024-09-10
Inscrição (estimada)
411
Tipo de estudo
Observacional
Status
Concluído
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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 | Insulin degludec Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp® Fast-acting insulin aspart Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp® |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, age above or equal to 18 years at the time of signing consent.
- Diagnosed with T1DM (Type 1 Diabetes Mellitus) for above or equal to 1 year (365 days) at the time of signing consent.
- On treatment with Tresiba® for more than or equal to 1 month (30 days) and Fiasp® for for more than or equal to 3 months (90 days) at the time of signing consent.
- The decision to initiate the use of commercially available NovoPen® 6 as a part of treatment with Tresiba® and Fiasp® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
- Current user of a rtCGM (Real-Time Continuous Glucose Monitoring) or isCGM (Intermittent-scanning Continuous Glucose Monitoring) for greather than or equal to 2 months (60 days) of which the last 14 days must be on rtCGM or isCGM, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott, at the time of signing consent.
- Willingness to continue using a rtCGM or isCGM for the duration of the study, which can integrate the data with diabetes treatment support solution from either Glooko or Abbott.
- Current user of a diabetes treatment support solution from either Glooko or Abbott, which can integrate the NovoPen® 6 injection data and the rtCGM/isCGM data, and willingness to continue using the same solution for the duration of the study.
- Previous participation in this study. Participation is defined as having given consent in this study.
- Treatment with any investigational drug within 30 days prior to enrolment into the study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Use of any smart pen or smart cap for the diabetes treatment prior to the signing consent.
Novo NordiskSem dados de contato.
26 Locais do estudo em 4 países
Imeldaziekenhuis - Bonheiden - Department of Endocrinology, Bonheiden, 2820, Belgium
HUB - Hôpital Erasme, 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, Malmo, 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