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Lo studio clinico NCT06668935 per Diabete mellito è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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AbbottProlongation of GLP-1 Adherence When Using Continuous Glucose Monitoring 800
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06668935 è uno studio osservazionale per Diabete mellito, attualmente in arruolamento. Avviato il 24 ottobre 2024, prevede di arruolare 800 partecipanti. Sotto la guida di Abbott, dovrebbe concludersi entro il 1 gennaio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 15 gennaio 2025.
Sommario breve
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.
Descrizione dettagliata
Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects wil...Mostra di più
Titolo ufficiale
Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
Patologie
Diabete mellitoAltri ID dello studio
- ADC-US-RES-24254
Numero NCT
Data di inizio (effettiva)
2024-10-24
Ultimo aggiornamento pubblicato
2025-01-15
Data di completamento (stimata)
2027-01
Arruolamento (previsto)
800
Tipo di studio
Osservazionale
Stato
In arruolamento
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Randomization to FSL 3 or Standard of Care Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes. | To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists All subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3. |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug | The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists. | 210 days |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Subject must be at least 18 years of age.
- Subject must be able to read and understand English.
- Subject must have a type 2 diabetes diagnosis.
- In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.
- Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.
- Subject must be willing to allow venous samples to be obtained to test HbA1c.
- Subject must be willing to either continue using their existing standard of care device or must be willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study.
- In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
- Subject must be available to participate in all study visits.
- Subject must be willing and able to provide written signed and dated informed consent.
- Subject is a member of the Study Staff.
- Subject has a diagnosis of type 1 or gestational diabetes.
- Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
- Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
- Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
- Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
- Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
- Subject currently is participating in another clinical trial.
- Subject is unsuitable for participation due to any other cause as determined by the Investigator
AbbottContatti principali dello studio
Contatto: Mohamed Mohamed Nada, PhD, 5107495416, [email protected]
Contatto: Shridhara Karinka, PhD, 510 7495416, [email protected]
2 Centri dello studio in 1 paesi
Florida
East Coast Institute for Research, LLC, Jacksonville, Florida, 32216, United States
Rebecca Goldfaden, Pharm D, Contatto, 904-854-1354, [email protected]
Wasim Deeb, MD, Investigatore principale
In arruolamento
Excellence Medical and Research, Miami Gardens, Florida, 33169, United States
Alexander Martinez, OD, Contatto, 786-320-5229, [email protected]
Miguel Trujillo, DNP, Investigatore principale
In arruolamento