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임상시험 NCT05069545 (CONNECT 1)은(는) 제1형 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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노보 노디스크A 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 디지털 헬스 모바일 앱
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05069545 (CONNECT 1)은(는) 제1형 당뇨병에 대해 알아본 관찰연구입니다. 현재 상태는 완료입니다. 연구는 2021년 10월 11일에 시작되어 411명의 참여자와 함께 진행되었습니다. 노보 노디스크이(가) 진행한 이 연구는 2024년 9월 10일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 12월 31일에 갱신되었습니다.
간단한 개요
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...
더 보기공식 제목
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
질환명
제1형 당뇨병기타 연구 식별자
- CONNECT 1
- DV3325-4759
- U1111-1255-5564 (기타 식별자) (World Health Organization (WHO))
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
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® |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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) |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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.
노보 노디스크연락처 정보가 없습니다.
26 4개국에 임상시험 장소
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