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Lo studio clinico NCT03340831 (COACH) per Diabete è sconosciuto. 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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Continuous Monitoring and Control of Hypoglycemia (COACH) 1.388
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La sperimentazione clinica NCT03340831 (COACH) è uno studio osservazionale per Diabete, attualmente sconosciuto. Avviato il 20 ottobre 2017, prevede di arruolare 1.388 partecipanti. Sotto la guida di DexCom, Inc., dovrebbe concludersi entro il 30 dicembre 2023. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 21 settembre 2021.
Sommario breve
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
Descrizione dettagliata
The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any m...Mostra di più
Titolo ufficiale
Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
Patologie
DiabeteAltri ID dello studio
- COACH
- PTL-901895
Numero NCT
Data di inizio (effettiva)
2017-10-20
Ultimo aggiornamento pubblicato
2021-09-21
Data di completamento (stimata)
2023-12-30
Arruolamento (previsto)
1.388
Tipo di studio
Osservazionale
Stato
Sconosciuto
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
CGM/BGM Group single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA). | Continuous Glucose Monitoring (CGM) Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM) |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in hypoglycemic events | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use | 6 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in A1C | Percent change in A1C lab between CGM use period compared to BGM use period. | 6 months |
Change in incidence of hypoglycemic events | Percent change of participants with at least one event between CGM use period compared to BGM use period. | 6 months |
Change in GMSS PRO scores | Percent change in mean scores for the Glucose monitoring satisfaction survey (GMSS) \[Emotional and Trust subscales\] between CGM use period compared to BGM use period. | 6 months |
Change in Diabetes Distress Scale (DDS) PRO scores | Percent change in mean scores for the DDS between CGM use period compared to BGM use period. | 6 months |
Change in Hypoglycemia Fear PRO scores | Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period. | 6 months |
Change in Hypoglycemia Confidence PRO scores | Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period. | 6 months |
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
2 Years
Sessi idonei
Tutti
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
- Use of RT-CGM, within the past 12 months
- Pregnancy
- Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
- Known (or suspected) significant allergy to medical grade adhesives
- Dialysis
DexCom, Inc.Contatti principali dello studio
Contatto: Stayce Beck, PhD, MPH, 8582036454, [email protected]
Contatto: Nelly Njeru, 8582036379, [email protected]
25 Centri dello studio in 1 paesi
California
Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States
Completato
Diabetes and Endocrine Associates, La Mesa, California, 91942, United States
Completato
Centre of Excellence in Diabetes and Endocrinology, Sacramento, California, 95821, United States
Mila Melnik, Contatto, [email protected]
Gnanagurudasan Prakasam, M.D., Investigatore principale
In arruolamento
Mills-Peninsula Medical Center, San Mateo, California, 94401, United States
Completato
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Completato
Florida
University of Florida Pediatric Endocrinology, Gainesville, Florida, 32608, United States
Attivo, non in arruolamento
Intervent Clinical Research Center, Pembroke Pines, Florida, 33024, United States
Marisela Rodriguez, Contatto, 954-507-6627, [email protected]
Diego Montes, MD, Investigatore principale
In arruolamento
University of South Florida Clinical Research Center, Tampa, Florida, 33612, United States
Ponja Hemphill, Contatto, [email protected]
Janet Rodriguez, Contatto, [email protected]
Henry Rodriguez, M.D., Investigatore principale
In arruolamento
Georgia
Atlanta Diabetes, Atlanta, Georgia, 30318, United States
Completato
Idaho
Rocky Mountain Diabetes Center, Idaho Falls, Idaho, 83404, United States
Completato
Illinois
Northshore University Health System, Skokie, Illinois, 60077, United States
Completato
Iowa
Iowa Diabetes & Endocrinology Research Center, Des Moines, Iowa, 50314, United States
Completato
Kansas
Cotton O'Neil Clinical Research, Topeka, Kansas, 66606, United States
Jaime Berroth, Contatto, [email protected]
Susan Brian, M.D., Investigatore principale
In arruolamento
Minnesota
International Diabetes Research Center, Minneapolis, Minnesota, 55416, United States
Completato
Missouri
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States
Jennifer L James, Contatto, [email protected];
Mark Clements, M.D.,PhD., Investigatore principale
In arruolamento
Nebraska
Methodist Physicians Clinic - Diabetes and Endocrine Specialists, Omaha, Nebraska, 68114, United States
Completato
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Completato
Carteret Medical Group, Morehead City, North Carolina, 28557, United States
Completato
Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States
Completato
Oklahoma
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology, Oklahoma City, Oklahoma, 73104, United States
LInda Weber, Contatto, [email protected]
David Sparling, M.D., Investigatore principale
In arruolamento
Tennessee
Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37212, United States
Completato
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States
Becky Cota, RN, CDE, Contatto, 806-358-8331, [email protected]
William Biggs, M.D., Investigatore principale
In arruolamento
Texas Diabetes and Endocrine, Austin, Texas, 78731, United States
Completato
Research Institute of Dallas, Dallas, Texas, 75231, United States
Completato
Utah
Advanced Research Associates, Ogden, Utah, 84405, United States
Hilary Wahlen, Contatto, 801-409-2040, [email protected]
Jack Wahlen, M.D., PhD, Investigatore principale
In arruolamento