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L'essai clinique NCT06962735 pour Diabète sucré 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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Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro) 220 Données vie réelle Observationnel
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 NCT06962735 a été une étude observationnel pour Diabète sucré. Son statut actuel est : terminé. L'étude a commencé le 25 janvier 2024, avec un objectif de recruter 220 participants. Dirigée par LMC Diabetes & Endocrinology Ltd., l'étude s'est terminée le 29 août 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 11 mai 2025.
Résumé succinct
The objective of this retrospective, observational study, is to better understand the real-world glycemic effectiveness of switching to real time continuous glucose monitoring (rtCGM) from intermittently scanned continuous glucose monitoring (isCGM) among adults with type 1 diabetes or type 2 diabetes in Canada.
Titre officiel
Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Diabetes: A Real-world, Canadian Retrospective Study
Pathologies
Diabète sucréAutres identifiants de l'étude
- Switch CGM retro
Numéro NCT
Date de début (réel)
2024-01-25
Dernière mise à jour publiée
2025-05-11
Date de fin (estimée)
2024-08-29
Inscription (estimée)
220
Type d'étude
Observationnel
Statut
Terminé
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
real-time continuous glucose monitoring switch group (rtCGM switch group) adults with diabetes that switched from an isCGM to an rtCGM | real-time continuous glucose monitor Individuals who switched from using isCGM to rtCGM |
intermittently scanned continuous glucose monitoring group (isCGM group) adults with diabetes that remained on an isCGM | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in HbA1c at 6-12-month follow-up compared to baseline | To evaluate change in HbA1c at 6-12-month follow-up compared to baseline after switching from an isCGM system to a rtCGM system in adults with type 1 diabetes | from index date to 6- to-12-month follow-up |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort | To compare 6-12 month change in HbA1c in the rtCGM switch cohort, who switched from isCGM to rtCGM, compared to a propensity score matched isCGM cohort, who maintained isCGM use, among a subgroup of patients with T1D and HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Change in percent time in target glucose range (TIR) at 6-12 months follow-up | To evaluate change in percent TIR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Change in percent time below target glucose range (TBR) | To evaluate change in percent TBR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Change in percent time above target glucose range (TAR) | To evaluate change in percent TAR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Change in mean glucose | To evaluate change in mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Change in standard deviation (SD) of mean glucose | To evaluate change in SD of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Change in coefficient of variation (CV) of mean glucose | To evaluate change in CV of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Change in weight | To evaluate change in weight at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Proportion of patients who achieve HbA1c ≤7.0% | To evaluate the proportion of patients who achieve HbA1c ≤7.0% at 6-12 months follow-up in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% at baseline and propensity score matched isCGM cohort with HbA1c ≥ 7.5% at baseline. | evaluated at 6- to-12-month follow-up |
Weekly incidence of self-reported hypoglycemia | To evaluate weekly incidence of self-reported hypoglycemia at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | evaluated at 6- to-12-month follow-up |
Proportion of patients with ≥ 1 self-reported hypoglycemic event | To evaluate proportion of patients with ≥ 1 self-reported hypoglycemic event at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | evaluated at 6- to-12-month follow-up |
Change in total daily dose (TDD) of insulin | To evaluate change in TDD of insulin at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. | from index date to 6- to-12-month follow-up |
Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort | To evaluate proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort during the study period from baseline to 6-12 months follow-up. | from index date to 6- to-12-month follow-up |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 18 years or older as of the index date
- Clinical diagnosis of T1D or T2D ≥ one year
- Using either MDI or CSII therapy
- Initiated a FreeStyle Libre® isCGM device between January 1, 2018 and July 31, 2023 (isCGM cohort)
- Switched from a FreeStyle Libre® 1 or Libre 2® isCGM device to a Dexcom® G5 or G6 CGM device between April 1, 2018 and July 31, 2023 (rtCGM cohort)
- Baseline HbA1c ≥7.0% for primary objective with rtCGM cohort
- Baseline HbA1c ≥8.0% for key secondary objective comparing rtCGM cohort to isCGM cohort
- Known rtCGM/isCGM start date (month and year)
- Exclusive use of isCGM for ≥ 3 months
- ≥ one HbA1c value up to 6 months (± 6 weeks) prior to index date (HbA1c value must be after isCGM initiation and no more than 6 weeks after the index date)
- ≥ one HbA1c value 6-12 months (± 6 weeks) following the index date
- Informed consent for their medical record data to be used for research purposes
- Have a prior history of rtCGM within 12 months of the index date
- Are pregnant at the time of isCGM initiation or time of switch to rtCGM
- Used the isCGM or rtCGM for < 3 months
LMC Diabetes & Endocrinology Ltd.DexCom, Inc.Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
Ontario
LMC Diabetes & Endocrinology Ltd., Toronto, Ontario, M4G3E8, Canada