רדאר קליני AI | ||
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הניסוי הקליני NCT05069545 (CONNECT 1) עבור סוכרת סוג 1 הוא הושלם. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
נובו נורדיסקA 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 בריאות דיגיטלית אפליקציה לנייד
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT05069545 (CONNECT 1) היה מחקר מסוג תצפיתי עבור סוכרת סוג 1, שכעת הושלם. המחקר התחיל ב-11 באוקטובר 2021 ותוכנן לכלול 411 משתתפים. המחקר נוהל על ידי נובו נורדיסק ותאריך הסיום היה 10 בספטמבר 2024. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-31 בדצמבר 2025.
סיכום קצר
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...
הצג עודכותרת רשמית
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
מצבים רפואיים
סוכרת סוג 1מזהי מחקר נוספים
- CONNECT 1
- DV3325-4759
- U1111-1255-5564 (מזהה אחר) (World Health Organization (WHO))
מספר NCT
תחילת המחקר (בפועל)
2021-10-11
עדכון אחרון שפורסם
2025-12-31
סיום המחקר (מוערך)
2024-09-10
משתתפים (מתוכנן)
411
סוג המחקר
תצפיתי
סטטוס
הושלם
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
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® |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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) |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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) |
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- 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.
נובו נורדיסק131 מחקרים פעילים לחקוראין נתוני קשר.
26 מיקומי המחקר ב-4 מדינות
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