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NCT Number: NCT06805786

Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)

The goal of this prospective study is to evaluate diabetes outcomes and patient experience following a switch from second generation intermittently scanned continuous glucose monitor (isCGM) to real-time continuous glucose monitor (rtCGM) compared with participants with continued isCGM use among adults with insulin-treated type 2 diabetes (T2D) in a specialist endocrinology clinic setting in Canada. The study aims include:

Primary outcome - Evaluate change in percent time in range (TIR) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with participants with continued second generation isCGM use.

Secondary outcomes - Compare glycemic and metabolic outcomes (ie. additional CGM metrics, HbA1c, and weight), and outcomes related to diabetes management (ie. self-reported hypoglycemia and change in total daily dose [TDD] of insulin) at 3-6 months follow-up in the rtCGM switch and isCGM cohorts among adults with insulin-treated T2D.

Exploratory outcomes - Evaluate patient-reported outcomes (PROs) in the rtCGM switch cohort only. PROs will include questions about device satisfaction and psychological distress at baseline and 3-6 months follow-up, and protocol-specific questions about Dexcom Care following use of the rtCGM device at 3-6 months follow-up. Additionally this study will compare percent TIR, percent TBR, percent TAR, and HbA1c between rtCGM switch and isCGM cohorts by insulin therapy subgroup (basal vs MDI therapy).

rtCGM switch participants will be enrolled at an LMC location and asked to complete PROs at baseline and 3-6 month follow-up. Continued isCGM participants will not be asked to complete PROs.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 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, M4G 3E8, Canada

Location status: Recruiting

Location contact

Manager, Data Science, LMC Healthcare

CONTACT

[email protected]

4166452929

Research Assistant, Data Science, LMC Healthcare

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Clinical diagnosis of T2D ≥ one year
  • Using insulin for ≥ 6 months
  • Continued FreeStyle Libre® 2 isCGM device (isCGM cohort) as of the study start date
  • Would like to switch from a FreeStyle Libre® 2 isCGM device to a Dexcom® G7 rtCGM device (rtCGM switch cohort) as of the study start date
  • Baseline HbA1c ≥ 7.5%
  • Known rtCGM/isCGM start date (month and year)
  • Exclusive use of isCGM for ≥ 3 months
  • Data on LibreView platforms have percent sensor capture ≥ 70% for 14 days of available data up to 6 months prior to index date
  • ≥ 1 value for TIR (%) up to 6 months (± 6 weeks) prior to index date
  • ≥ 1 value for HbA1c (%) up to 6 months (± 6 weeks) prior to index date
  • Data consent

Exclusion criteria

  • Have a prior history of rtCGM within 12 months of the index date
  • Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
  • Recent or expectant titration of insulin dose ≥ 20% within 30 days of index date
  • Are pregnant at the time of study enrollment or intending to become pregnant during the study
  • Used the isCGM or rtCGM for < 3 months
  • Using continuous subcutaneous insulin infusion

Treatment and study plan

Real-time continuous glucose monitor

Device

Individuals who switched from using isCGM to rtCGM

Primary outcomes

  1. Change in Percent Time in Range (TIR)

    Time frame: from enrollment to 6 months follow up

    evaluate change in percent TIR (3.9 to 10.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D. Percent TIR will be reported from the patient's EMR or Clarity® and LibreView® platforms (last 14 days of available data closest to the index date or 6-month follow-up date, where percent sensor capture is ≥ 70%).

Secondary outcomes

  1. Change in Percent Time Below Range (TBR)

    Time frame: from enrollment to 6 months follow up

    Evaluate change in percent TBR (<3.9 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  2. Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia

    Time frame: from enrollment to 6 months follow up

    Evaluate change in percent TBR in level 2 hypoglycemia (<3.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  3. Change in Percent Time Above Target Glucose Range (TAR)

    Time frame: from enrollment to 6 months follow up

    Evaluate change in percent TAR (>10.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  4. Change in Mean Glucose

    Time frame: from enrollment to 6 months follow up

    Evaluate change in mean glucose (mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  5. Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L)

    Time frame: from enrollment to 6 months follow up

    Evaluate change in glycemic variability reported as standard deviation (SD) (mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  6. Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%)

    Time frame: from enrollment to 6 months follow up

    Evaluate change in glycemic variability reported as CV (%) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  7. Change in Frequency of Hypoglycemia Episodes

    Time frame: from enrollment to 6 months follow up

    Evaluate change in frequency of hypoglycemia episodes (frequency of events <3.9 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  8. Percent Sensor Capture and Change in Percent Capture

    Time frame: from enrollment to 6 months follow up

    Evaluate Percent sensor capture and evaluate the change in percent sensor capture at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  9. Change in HbA1c

    Time frame: from enrollment to 6 months follow up

    Evaluate change in HbA1c (%) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  10. Portion of Participants Achieving HbA1c ≤7.0% at Follow-Up

    Time frame: from enrollment to 6 months follow up

    Evaluate portion of participants achieving HbA1c ≤ 7.0% at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  11. Change in Weight

    Time frame: from enrollment to 6 months follow up

    Evaluate change in weight (kg) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  12. Change in Weekly Incidence of Self-Reported Hypoglycemia

    Time frame: from enrollment to 6 months follow up

    Evaluate change in weekly incidence of self-reported hypoglycemia at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  13. Change in Proportion of Participants with ≥1 Self-reported Hypoglycemic Events per Week

    Time frame: from enrollment to 6 months follow up

    Evaluate change in proportion of participants with ≥1 self-reported hypoglycemic events per week at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  14. Change in Number of Non-Insulin Antihyperglycemic Agents (AHA)

    Time frame: from enrollment to 6 months follow up

    Evaluate change in number of non-insulin AHAs at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  15. Change in Total Daily Dose (TDD) of Insulin

    Time frame: from enrollment to 6 months follow up

    Evaluate change in total daily dose of insulin at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.

  16. Number of rtCGM Discontinuations

    Time frame: from enrollment to 6 months follow up

    Evaluate the number of rtCGM discontinuations at 3-6 months follow-up only for the cohort switching from a second generation isCGM system to a rtCGM system.

Other outcomes

  1. Glucose Monitoring Device Satisfaction Scale (GMSS)

    Time frame: from enrollment to 6 months follow up

    includes questions about device satisfaction, filled out only by the cohort switching from isCGM to rtCGM

  2. Diabetes Distress Scale (DDS)

    Time frame: from enrollment to 6 months follow up

    includes questions about psychological distress , filled out only by the cohort switching from isCGM to rtCGM

  3. Protocol-Specific Dexcom Care Survey

    Time frame: assessed at 3-6 month follow-up

    includes protocol-specific questions about rtCGM device, filled out only by the cohort switching from isCGM to rtCGM

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 Type 2 Diabetes

Acronym: Switch CGM T2D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2025
Registry last updated
May 4, 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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