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Completed

NCT Number: NCT06962735

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G3E8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time continuous glucose monitor

Device

Individuals who switched from using isCGM to rtCGM

Primary outcomes

  1. Change in HbA1c at 6-12-month follow-up compared to baseline

    Time frame: from index date to 6- to-12-month follow-up

    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

Secondary outcomes

  1. Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  2. Change in percent time in target glucose range (TIR) at 6-12 months follow-up

    Time frame: from index date to 6- to-12-month 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%.

  3. Change in percent time below target glucose range (TBR)

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  4. Change in percent time above target glucose range (TAR)

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  5. Change in mean glucose

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  6. Change in standard deviation (SD) of mean glucose

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  7. Change in coefficient of variation (CV) of mean glucose

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  8. Change in weight

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  9. Proportion of patients who achieve HbA1c ≤7.0%

    Time frame: evaluated at 6- to-12-month follow-up

    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.

  10. Weekly incidence of self-reported hypoglycemia

    Time frame: evaluated at 6- to-12-month follow-up

    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%.

  11. Proportion of patients with ≥ 1 self-reported hypoglycemic event

    Time frame: evaluated at 6- to-12-month follow-up

    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%.

  12. Change in total daily dose (TDD) of insulin

    Time frame: from index date to 6- to-12-month follow-up

    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%.

  13. Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort

    Time frame: from index date to 6- to-12-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 8, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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