Trial Radar IA | ||
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Lo studio clinico NCT06719531 per Diabete mellito di tipo 1, Diabete mellito di tipo 2 è ritirato. 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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SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
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 NCT06719531 è uno studio interventistico per Diabete mellito di tipo 1, Diabete mellito di tipo 2, attualmente ritirato. Avviato il 1 maggio 2025, prevede di arruolare N.D. partecipanti. Sotto la guida di Medtronic Diabetes, dovrebbe concludersi entro il 1 dicembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 3 giugno 2025.
Sommario breve
The purpose of this study is to find out how well a new continuous glucose monitor works for people with diabetes. This study will test the performance of the study sensor(s) for 7-14 days of wear in patients who are 11-80 years old with type 1 or type 2 diabetes.
Titolo ufficiale
SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes
Patologie
Diabete mellito di tipo 1Diabete mellito di tipo 2Altri ID dello studio
- CIP345
Numero NCT
Data di inizio (effettiva)
2025-05
Ultimo aggiornamento pubblicato
2025-06-03
Data di completamento (stimata)
2025-12
Tipo di studio
Interventistico
FASE
N.D.
Stato
Ritirato
Scopo principale
Altro
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleSubjects with diabetes wearing DS5 Subjects wearing DS5 over 7-14 days and participating in FSTs | Monitoraggio continuo del glucosio CGM and frequent sample testing |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Primary Safety Endpoints | Descriptive summary will be used to characterize:
• Skin assessment of subject's glucose sensor insertion sites | The subject's participation from study enrollment to study exit is approximately 7 to 44 days. |
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
11 Years
Sessi idonei
Tutti
- Age 11-80 years at time of screening.
- Has a clinical diagnosis of type 1 or type 2 diabetes for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
- Subject or parent(s)/guardian(s) is/are literate and able to read the language offered in the study materials.
- Subject and/or legally authorized representative is willing to provide informed consent for participation.
- Has adequate venous access as assessed by investigator or appropriate staff.
- Is willing to perform fingerstick blood glucose measurements as needed.
- Is willing to wear the study devices continuously throughout the study.
- Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.
- Has had a hypoglycemic seizure within the past 6 months prior to screening visit.
- Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
- Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone.
- Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.
- Has a history of a seizure disorder.
- Has a central nervous system or cardiac disorder resulting in syncope.
- Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Is pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant).
- Has diagnosis of adrenal insufficiency.
- Is using hydroxyurea at time of screening or plans to use it during the study.
- Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks. (Please note participation in an observational study is acceptable.)
- Has a planned procedure involving the use of a Magnetic Resonance Imaging (MRI), diathermy devices, or other devices that generate strong magnetic fields (e.g., x-ray, CT scan, or other types of radiation) during the study wear period.
- Has elective surgery or hospitalization planned during the course of the study.
- Has a clinical diagnosis of type 1 and is using pramlintide (Symlin), DPP-4 inhibitor, GLP-1 receptor agonist, metformin, and/or SGLT2 inhibitor at time of screening.
- Is currently abusing illicit drug(s).
- Is currently abusing marijuana.
- Is currently abusing prescription medication(s).
- Is currently abusing alcohol.
- Has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
- Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
- Has had any of the following cardiovascular events 1 year or more prior to screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. Subject may be enrolled if clearance from a cardiologist is provided prior to or at screening.
- Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- Is a member of the research staff involved with the study.
- Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).
Medtronic DiabetesNessun dato di contatto
28 Centri dello studio in 1 paesi
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
California
ProSciento, Chula Vista, California, 91911, United States
John Muir Health, Concord, California, 94520, United States
Headlands Research California, LLC, Escondido, California, 92025, United States
Sansum Diabetes Research Institute, Goleta, California, 93111, United States
Rady Children's Hospital, San Diego, California, 92123, United States
University of California San Francisco, San Francisco, California, 94158, United States
Mills-Peninsula Medical Center: Diabetes Research Institute, San Mateo, California, 94401, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Colorado
Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States
Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States
Florida
University of Florida, Gainesville, Florida, 32610, United States
Georgia
Atlanta Diabetes, Atlanta, Georgia, 30318, United States
Endocrine Research Solutions, Roswell, Georgia, 30076, United States
Idaho
Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States
Iowa
Iowa Diabetes and Endocrinology Center, West Des Moines, Iowa, 50265, United States
Maryland
Barry J Reiner, MD, LLC, Baltimore, Maryland, 21229, United States
Massachusetts
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
New York
Northwell Health, New Hyde Park, New York, 11042v, United States
North Carolina
Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, 27104, United States
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Tennessee
ClinRé 001-007, Bartlett, Tennessee, 38133, United States
Texas
Texas Diabetes and Endocrinology, Austin, Texas, 78749, United States
Tekton Research, McKinney, Texas, 75069, United States
Texas Diabetes & Endocrinology, Round Rock, Texas, 78681, United States
Diabetes & Glandular Disease Clinic, San Antonio, Texas, 78229, United States
Virginia
University of Virginia Health System, Charlottesville, Virginia, 22903, United States
Washington
Rainier Clinical Research Center, Renton, Washington, 98057, United States