Type 2 DiabetesSwitch CGM T2DNCT06805786
Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)
An observational study of Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- real-time continuous glucose monitor
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 11 Feb 2025to Jul 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adults, who are active patients with insulin-treated T2D at LMC, who switch from a FreeStyle Libre® 2 device to a Dexcom® G7 (rtCGM switch cohort) or initiated a FreeStyle Libre® 2 and maintain isCGM use (isCGM cohort) after December 2024
Who may be able to join
- 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%
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, M4G 3E8
Manager, Data Science, LMC Healthcare, 4166452929, lisa.chu@lmc.ca
Research Assistant, Data Science, LMC Healthcare, giovana.romero@lmc.ca
About this study
Official 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
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.
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- real-time continuous glucose monitor
- Keywords
- type 2 diabetes, continuous glucose monitoring, HbA1c, time in range
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time continuous glucose monitorDevice
Individuals who switched from using isCGM to rtCGM
| Study group | Role | What they receive |
|---|---|---|
| Real-time continuous glucose monitoring switch group (rtCGM switch group) | adults with insulin-treated T2D that are switching from an isCGM to an rtCGM Receives: Device: real-time continuous glucose monitor | |
| intermittently scanned continuous glucose monitoring group (isCGM group) | adults with insulin-treated T2D that are remaining on an isCGM for the whole study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Time in Range (TIR)
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%).
Measured: from enrollment to 6 months follow up
Secondary outcomes (16)
Change in Percent Time Below Range (TBR)
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.
Measured: from enrollment to 6 months follow up
Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia
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.
Measured: from enrollment to 6 months follow up
Change in Percent Time Above Target Glucose Range (TAR)
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.
Measured: from enrollment to 6 months follow up
Change in Mean Glucose
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.
Measured: from enrollment to 6 months follow up
Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L)
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.
Measured: from enrollment to 6 months follow up
Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%)
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.
Measured: from enrollment to 6 months follow up
Change in Frequency of Hypoglycemia Episodes
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.
Measured: from enrollment to 6 months follow up
Percent Sensor Capture and Change in Percent Capture
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.
Measured: from enrollment to 6 months follow up
Change in HbA1c
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.
Measured: from enrollment to 6 months follow up
Portion of Participants Achieving HbA1c ≤7.0% at 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.
Measured: from enrollment to 6 months follow up
Change in Weight
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.
Measured: from enrollment to 6 months follow up
Change in Weekly Incidence of Self-Reported Hypoglycemia
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.
Measured: from enrollment to 6 months follow up
Change in Proportion of Participants with ≥1 Self-reported Hypoglycemic Events per Week
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.
Measured: from enrollment to 6 months follow up
Change in Number of Non-Insulin Antihyperglycemic Agents (AHA)
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.
Measured: from enrollment to 6 months follow up
Change in Total Daily Dose (TDD) of Insulin
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.
Measured: from enrollment to 6 months follow up
Number of rtCGM Discontinuations
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.
Measured: from enrollment to 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start11 Feb 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805786
- Sponsor's protocol ID
- Switch CGM T2D
- Acronym
- Switch CGM T2D
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: This is a real-world study using data retrieved from a national Diabetes Registry. IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06805786
- Acronym / sponsor ID
- Switch CGM T2D / Switch CGM T2D
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, continuous glucose monitoring, HbA1c, time in range
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time continuous glucose monitoring switch group (rtCGM switch group) | – | Device: real-time continuous glucose monitoradults with insulin-treated T2D that are switching from an isCGM to an rtCGM |
| intermittently scanned continuous glucose monitoring group (isCGM group) | – | –adults with insulin-treated T2D that are remaining on an isCGM for the whole study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adults, who are active patients with insulin-treated T2D at LMC, who switch from a FreeStyle Libre® 2 device to a Dexcom® G7 (rtCGM switch cohort) or initiated a FreeStyle Libre® 2 and maintain isCGM use (isCGM cohort) after December 2024
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time continuous glucose monitorIndividuals who switched from using isCGM to rtCGM | Device | Real-time continuous glucose monitoring switch group (rtCGM switch group) |
Primary outcome
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%).
16 secondary outcomes
Change in Percent Time Below Range (TBR)
Time frame: from enrollment to 6 months follow up
Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia
Time frame: from enrollment to 6 months follow up
Change in Percent Time Above Target Glucose Range (TAR)
Time frame: from enrollment to 6 months follow up
Change in Mean Glucose
Time frame: from enrollment to 6 months follow up
Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L)
Time frame: from enrollment to 6 months follow up
Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%)
Time frame: from enrollment to 6 months follow up
Change in Frequency of Hypoglycemia Episodes
Time frame: from enrollment to 6 months follow up
Percent Sensor Capture and Change in Percent Capture
Time frame: from enrollment to 6 months follow up
Change in HbA1c
Time frame: from enrollment to 6 months follow up
Portion of Participants Achieving HbA1c ≤7.0% at Follow-Up
Time frame: from enrollment to 6 months follow up
Change in Weight
Time frame: from enrollment to 6 months follow up
Change in Weekly Incidence of Self-Reported Hypoglycemia
Time frame: from enrollment to 6 months follow up
Change in Proportion of Participants with ≥1 Self-reported Hypoglycemic Events per Week
Time frame: from enrollment to 6 months follow up
Change in Number of Non-Insulin Antihyperglycemic Agents (AHA)
Time frame: from enrollment to 6 months follow up
Change in Total Daily Dose (TDD) of Insulin
Time frame: from enrollment to 6 months follow up
Number of rtCGM Discontinuations
Time frame: from enrollment to 6 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No. This is a real-world study using data retrieved from a national Diabetes Registry. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Time in Range (TIR) (time frame: from enrollment to 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.