Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)

NCT ID: NCT06962735

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-25

Study Completion Date

2024-08-29

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type DEVICE

Individuals who switched from using isCGM to rtCGM

intermittently scanned continuous glucose monitoring group (isCGM group)

adults with diabetes that remained on an isCGM

No interventions assigned to this group

Interventions

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real-time continuous glucose monitor

Individuals who switched from using isCGM to rtCGM

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

LMC Diabetes & Endocrinology Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Switch CGM retro

Identifier Type: -

Identifier Source: org_study_id

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