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Die klinische Studie NCT04809311 für Diabetes mellitus Typ 2 ist abgeschlossen. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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Novo NordiskRemote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments 156 Remote/Fern Virtuell
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Die klinische Studie NCT04809311 untersuchte Diabetes mellitus Typ 2 als beobachtungsstudie und hat den Status abgeschlossen. Die Studie begann am 30. April 2024 mit 156 Teilnehmern. Sie wurde durchgeführt von Novo Nordisk und am 7. Januar 2025 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 21. März 2025 aktualisiert.
Kurzbeschreibung
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, e...Mehr anzeigen
Offizieller Titel
Fully Decentralised Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Participants With Type 2 Diabetes Mellitus on Different Treatment Regimens
Erkrankungen
Diabetes mellitus Typ 2Weitere Studien-IDs
- NN1535-7774
- U1111-1254-5030 (Andere Kennung) (World Health Organization (WHO))
NCT-Nummer
Studienbeginn (tatsächlich)
2024-04-30
Zuletzt aktualisiert
2025-03-21
Studienende (vorauss.)
2025-01-07
Geplante Rekrutierung
156
Studientyp
Beobachtungsstudie
Status
Abgeschlossen
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Other oral antidiabetic drugs (OADs) ± metformin Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Oral antidiabetetic drugs During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Basal insulin ± OADs Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Basal insulin During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Basal insulin During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration Glucagon-like peptide-1 (GLP-1) During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Participant invited to consent and consented via e-signature (Yes/No) | Measured as count of participants. | During Screening (Week -2 to week 0 ) |
Participant with at least 70% unblinded CGM (continuous glucose monitoring) data (Yes/No) | Measured as Count of participants. | From time of first unblinded CGM measurement until 10 weeks after the time of first unblinded CGM measurement |
Participant completion of questionnaires and per protocol planned remote visits (RVs) | % of questionnaires and RVs completed. | From week 0 until end of study (week 12) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Time in range (TIR) (3.9-10 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time above range (TAR) (above 10 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time below range (TBR) L1 (3.0-3.9 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time below range (TBR) L2 (below 3.0 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Mean glucose | nmol/L. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Coefficient of variation (CV) of glucose measurements | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | |
Participant with at least 70% heart rate (pulse) data (Yes/No) | Count of participants. | From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Willingness to consent via the e-consent process before any study-related activities takes place (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 informed consent
Diagnosed T2DM for more than 3 months prior to signing the informed consent
On one of the following treatments for T2DM:
- Metformin ± other OADs
- Basal insulin ± OADs
- GLP-1 ± Basal insulin (loose and fixed combination) ± OADs
Willingness to, and capable of applying and using the study devices
Willingness to follow study procedures
Fluent in Danish both oral, reading and in writing
In possession of a compatible smartphone throughout the study, meaning that the smartphone fulfils the criteria to the operating system for using the devices needed for the study
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any other study investigating diabetes.
- Patients who do not have a blood glucose meter at home
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