Trial Radar KI | ||
|---|---|---|
Die klinische Studie NCT03340831 (COACH) für Diabetes ist unbekannter status. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Continuous Monitoring and Control of Hypoglycemia (COACH) 1.388
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT03340831 (COACH) ist eine beobachtungsstudie zur Untersuchung von Diabetes und hat den Status unbekannter status. Die Studie startete am 20. Oktober 2017 und soll 1.388 Teilnehmer aufnehmen. Durchgeführt von DexCom, Inc. ist der Abschluss für 30. Dezember 2023 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 21. September 2021 aktualisiert.
Kurzbeschreibung
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel
Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
Erkrankungen
DiabetesWeitere Studien-IDs
- COACH
- PTL-901895
NCT-Nummer
Studienbeginn (tatsächlich)
2017-10-20
Zuletzt aktualisiert
2021-09-21
Studienende (vorauss.)
2023-12-30
Geplante Rekrutierung
1.388
Studientyp
Beobachtungsstudie
Status
Unbekannter Status
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
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) |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in hypoglycemic events | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use | 6 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
2 Years
Zugelassene Geschlechter
Alle
- 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.Zentrale Studienkontakte
Kontakt: Stayce Beck, PhD, MPH, 8582036454, [email protected]
Kontakt: Nelly Njeru, 8582036379, [email protected]
25 Studienstandorte in 1 Ländern
California
Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States
Abgeschlossen
Diabetes and Endocrine Associates, La Mesa, California, 91942, United States
Abgeschlossen
Centre of Excellence in Diabetes and Endocrinology, Sacramento, California, 95821, United States
Mila Melnik, Kontakt, [email protected]
Gnanagurudasan Prakasam, M.D., Hauptprüfer
Offene Rekrutierung
Mills-Peninsula Medical Center, San Mateo, California, 94401, United States
Abgeschlossen
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Abgeschlossen
Florida
University of Florida Pediatric Endocrinology, Gainesville, Florida, 32608, United States
Aktiv, nicht rekrutierend
Intervent Clinical Research Center, Pembroke Pines, Florida, 33024, United States
Marisela Rodriguez, Kontakt, 954-507-6627, [email protected]
Diego Montes, MD, Hauptprüfer
Offene Rekrutierung
University of South Florida Clinical Research Center, Tampa, Florida, 33612, United States
Ponja Hemphill, Kontakt, [email protected]
Janet Rodriguez, Kontakt, [email protected]
Henry Rodriguez, M.D., Hauptprüfer
Offene Rekrutierung
Georgia
Atlanta Diabetes, Atlanta, Georgia, 30318, United States
Abgeschlossen
Idaho
Rocky Mountain Diabetes Center, Idaho Falls, Idaho, 83404, United States
Abgeschlossen
Illinois
Northshore University Health System, Skokie, Illinois, 60077, United States
Abgeschlossen
Iowa
Iowa Diabetes & Endocrinology Research Center, Des Moines, Iowa, 50314, United States
Abgeschlossen
Kansas
Cotton O'Neil Clinical Research, Topeka, Kansas, 66606, United States
Jaime Berroth, Kontakt, [email protected]
Susan Brian, M.D., Hauptprüfer
Offene Rekrutierung
Minnesota
International Diabetes Research Center, Minneapolis, Minnesota, 55416, United States
Abgeschlossen
Missouri
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States
Jennifer L James, Kontakt, [email protected];
Mark Clements, M.D.,PhD., Hauptprüfer
Offene Rekrutierung
Nebraska
Methodist Physicians Clinic - Diabetes and Endocrine Specialists, Omaha, Nebraska, 68114, United States
Abgeschlossen
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Abgeschlossen
Carteret Medical Group, Morehead City, North Carolina, 28557, United States
Abgeschlossen
Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States
Abgeschlossen
Oklahoma
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology, Oklahoma City, Oklahoma, 73104, United States
LInda Weber, Kontakt, [email protected]
David Sparling, M.D., Hauptprüfer
Offene Rekrutierung
Tennessee
Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37212, United States
Abgeschlossen
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States
Becky Cota, RN, CDE, Kontakt, 806-358-8331, [email protected]
William Biggs, M.D., Hauptprüfer
Offene Rekrutierung
Texas Diabetes and Endocrine, Austin, Texas, 78731, United States
Abgeschlossen
Research Institute of Dallas, Dallas, Texas, 75231, United States
Abgeschlossen
Utah
Advanced Research Associates, Ogden, Utah, 84405, United States
Hilary Wahlen, Kontakt, 801-409-2040, [email protected]
Jack Wahlen, M.D., PhD, Hauptprüfer
Offene Rekrutierung