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L'essai clinique NCT03566693 (MOBILE) pour Diabète sucré de type 2 est terminé. 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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Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE) 176 À distance
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT03566693 (MOBILE) a été une étude interventionnel pour Diabète sucré de type 2. Son statut actuel est : terminé. L'étude a commencé le 30 juillet 2018, avec un objectif de recruter 176 participants. Dirigée par DexCom, Inc., l'étude s'est terminée le 4 janvier 2021. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 avril 2021.
Résumé succinct
A study to compare the glycemic and quality of life benefits of diabetes management using Dexcom G6 continuous glucose monitoring (CGM) or self-monitored blood glucose (SMBG) made by study participants and their primary care physicians. Decisions will be based on insights from real-time use and retrospective insights, determined during remote visits.
Participants will have type 2 diabetes and be using basal insulin ...
Afficher plusDescription détaillée
The study is referred to as the "Continuous Glucose MOnitoring in T2D Basal InsuLin UsErs, also known as The MOBILE Study" and will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus traditional Blood Glucose Monitoring (BGM) in people with Type 2 Diabetes using basal insulin with or without oral medications and who have an elevated HbA1c between 7.8 -11.5%. In this study, the investigator'...Afficher plus
Titre officiel
Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
Pathologies
Diabète sucré de type 2Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- MOBILE
- PTL-902822
Numéro NCT
Date de début (réel)
2018-07-30
Dernière mise à jour publiée
2021-04-21
Date de fin (estimée)
2021-01-04
Inscription (estimée)
176
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalContinous Glucose Monitor | Dexcom G6 CGM System continuous glucose monitor |
Comparateur actifSelf Monitoring Blood Glucose | Blood glucose meter Blue-tooth enabled blood glucose meter |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Phase 1: Change in HbA1c | Phase 1: Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to Month 8 | Baseline to Month 8 |
Phase 2: Change in CGM time in target range | Between group differences for the Phase 1 CGM Group re-randomized to Discontinue CGM (use SMBG only) or to Continue CGM for the change in time in target range (70-180 mg/dL) from Month 8 to Month 14 | Month 8 to Month 14 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Phase 1: Change in CGM time in target range | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time in target range 70-180 mg/dL | Baseline to Month 8 |
Phase 1: Change in CGM time-hyperglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as \>250 mg/dL | Baseline to Month 8 |
Phase 1: Change in mean glucose from CGM | Between group differences (CGM and SMBG) from baseline to Month 8 of change in mean glucose from CGM | Baseline to Month 8 |
Phase 1: Percent decreasing HbA1c by ≥0.5% | Between group differences (CGM and SMBG) from baseline to Month 8 of percent decreasing HbA1c by ≥0.5% (absolute) | Baseline to Month 8 |
Phase 1: Proportion increasing CGM time in target range by ≥10% and ≥15% | Between group differences (CGM and SMBG) from baseline to Month 8 of proportion increasing CGM time in target range by ≥10% and ≥15% (absolute) | Baseline to Month 8 |
Phase 1: Percent adding or removing diabetes medications | Between group differences (CGM and SMBG) from baseline to Month 8 of percent adding or removing diabetes medications (starting or stopping medications) | Baseline to Month 8 |
Phase 1: Change in HbA1c based on their baseline HbA1c | Between group differences (CGM and SMBG) from baseline to Month 8 of change in HbA1c based on their baseline HbA1c (restricted to participants with baseline HbA1c ≥8.5%,≥9.0%, ≥9.5%, ≥10.0%) | Baseline to Month 8 |
Phase 1: Change in CGM glucose variability | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM glucose variability measured by the coefficient of variation | Baseline to Month 8 |
Phase 1: Change in CGM time-hypoglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hypoglycemic, defined as \<70mg/dL | Baseline to Month 8 |
Phase 2: Change in HbA1c | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in HbA1c (central lab) | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Change in CGM time-hyperglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as \>250 mg/dL | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Percent decreasing HbA1c by ≥0.5% | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of percent decreasing HbA1c by ≥0.5% (absolute) | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Proportion increasing CGM time in target range by ≥10% and ≥15% | Month 8 to Month 14 \& Baseline to Month 14 | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of proportion increasing |
Phase 2: Percent adding or removing diabetes medications | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of percent adding or removing diabetes medications (starting or stopping medication) | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Change in CGM glucose variability | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in CGM glucose variability measured by the coefficient of variation | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Change in CGM time-hypoglycemic | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in CGM time-hypoglycemic, defined as \<70mg/dL | Month 8 to Month 14 & Baseline to Month 14 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
30 Years
Sexes éligibles
Tous
- Age 30 or older
- Diagnosis of Type 2 diabetes
- HbA1c between 7.8-11.5%
- Use of basal insulin, with or without concomitant use of oral agents or GLP-1 agonist
- Pregnancy
- Renal disease
- Conditions that impact the stability of a HbA1c measurement
- Use of prandial insulin
DexCom, Inc.Jaeb Center for Health ResearchAucune donnée de contact disponible
15 Centres de l'étude dans 1 pays
California
Keck School of Medicine @ USC, Los Angeles, California, 90022, United States
Scripps Whittier Diabetes Institute, San Diego, California, 92121, United States
Georgia
Emory University, Atlanta, Georgia, 30303, United States
Illinois
Northwestern Memorial, Chicago, Illinois, 60611, United States
Iowa
Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States
Michigan
University of Michigan Internal Medicine, Ann Arbor, Michigan, 48105, United States
Henry Ford Medical Center, Detroit, Michigan, 48202, United States
Minnesota
Park Nicollet International Diabetes Center, Minneapolis, Minnesota, 55416, United States
Missouri
Washington University Barnes Jewish Hospital, St Louis, Missouri, 63130, United States
Nevada
Las Vegas Endocrinology, Henderson, Nevada, 89052, United States
North Carolina
University of North Carolina, Chapel Hill, North Carolina, 27517, United States
Carteret Medical Group, Morehead City, North Carolina, 28557, United States
Lucas Research / Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States
Tennessee
Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37212, United States
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States