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L'essai clinique NCT03340831 (COACH) pour Diabète est inconnu. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Continuous Monitoring and Control of Hypoglycemia (COACH) 1 388
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L'essai clinique NCT03340831 (COACH) est une étude observationnel pour Diabète. Son statut actuel est : inconnu. L'étude a débuté le 20 octobre 2017 et vise à recruter 1 388 participants. Dirigée par DexCom, Inc., l'étude devrait être terminée d'ici le 30 décembre 2023. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 septembre 2021.
Résumé succinct
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
Description détaillée
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...Afficher plus
Titre officiel
Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
Pathologies
DiabèteAutres identifiants de l'étude
- COACH
- PTL-901895
Numéro NCT
Date de début (réel)
2017-10-20
Dernière mise à jour publiée
2021-09-21
Date de fin (estimée)
2023-12-30
Inscription (estimée)
1 388
Type d'étude
Observationnel
Statut
Inconnu
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
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) |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in hypoglycemic events | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use | 6 months |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
2 Years
Sexes éligibles
Tous
- 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.Contact central de l'étude
Contact: Stayce Beck, PhD, MPH, 8582036454, [email protected]
Contact: Nelly Njeru, 8582036379, [email protected]
25 Centres de l'étude dans 1 pays
California
Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States
Terminé
Diabetes and Endocrine Associates, La Mesa, California, 91942, United States
Terminé
Centre of Excellence in Diabetes and Endocrinology, Sacramento, California, 95821, United States
Mila Melnik, Contact, [email protected]
Gnanagurudasan Prakasam, M.D., Investigateur principal
En recrutement
Mills-Peninsula Medical Center, San Mateo, California, 94401, United States
Terminé
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Terminé
Florida
University of Florida Pediatric Endocrinology, Gainesville, Florida, 32608, United States
Actif, ne recrute pas
Intervent Clinical Research Center, Pembroke Pines, Florida, 33024, United States
Marisela Rodriguez, Contact, 954-507-6627, [email protected]
Diego Montes, MD, Investigateur principal
En recrutement
University of South Florida Clinical Research Center, Tampa, Florida, 33612, United States
Ponja Hemphill, Contact, [email protected]
Janet Rodriguez, Contact, [email protected]
Henry Rodriguez, M.D., Investigateur principal
En recrutement
Georgia
Atlanta Diabetes, Atlanta, Georgia, 30318, United States
Terminé
Idaho
Rocky Mountain Diabetes Center, Idaho Falls, Idaho, 83404, United States
Terminé
Illinois
Northshore University Health System, Skokie, Illinois, 60077, United States
Terminé
Iowa
Iowa Diabetes & Endocrinology Research Center, Des Moines, Iowa, 50314, United States
Terminé
Kansas
Cotton O'Neil Clinical Research, Topeka, Kansas, 66606, United States
Jaime Berroth, Contact, [email protected]
Susan Brian, M.D., Investigateur principal
En recrutement
Minnesota
International Diabetes Research Center, Minneapolis, Minnesota, 55416, United States
Terminé
Missouri
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States
Jennifer L James, Contact, [email protected];
Mark Clements, M.D.,PhD., Investigateur principal
En recrutement
Nebraska
Methodist Physicians Clinic - Diabetes and Endocrine Specialists, Omaha, Nebraska, 68114, United States
Terminé
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Terminé
Carteret Medical Group, Morehead City, North Carolina, 28557, United States
Terminé
Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States
Terminé
Oklahoma
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology, Oklahoma City, Oklahoma, 73104, United States
LInda Weber, Contact, [email protected]
David Sparling, M.D., Investigateur principal
En recrutement
Tennessee
Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37212, United States
Terminé
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States
Becky Cota, RN, CDE, Contact, 806-358-8331, [email protected]
William Biggs, M.D., Investigateur principal
En recrutement
Texas Diabetes and Endocrine, Austin, Texas, 78731, United States
Terminé
Research Institute of Dallas, Dallas, Texas, 75231, United States
Terminé
Utah
Advanced Research Associates, Ogden, Utah, 84405, United States
Hilary Wahlen, Contact, 801-409-2040, [email protected]
Jack Wahlen, M.D., PhD, Investigateur principal
En recrutement