Diabetes MellitusNCT06962735
Real-world Effect of Switching From Intermittently-scanned to Real-time Continuous Glucose Monitoring (Switch CGM Retro)
An observational study of Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- real-time continuous glucose monitor
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2024to 29 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 includes adults, who were active patients with type 1 diabetes or type 2 diabetes at LMC, who switched from intermittently scanned continuous glucose monitoring to real-time continuous glucose monitoring (rtCGM switch cohort) or initiated and maintained intermittently scanned continuous glucose monitoring use (isCGM cohort).
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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 Diabetes: A Real-world, Canadian Retrospective Study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- real-time continuous glucose monitor
- Medical subject headings
- Diabetes Mellitus
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 diabetes that switched from an isCGM to an rtCGM Receives: Device: real-time continuous glucose monitor | |
| intermittently scanned continuous glucose monitoring group (isCGM group) | adults with diabetes that remained on an isCGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from index date to 6- to-12-month follow-up
Secondary outcomes (13)
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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: from index date to 6- to-12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start25 Jan 2024
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Retrospective
- Enrolment
- 220 participants (actual)
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
- NCT06962735
- Sponsor's protocol ID
- Switch CGM retro
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 11 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 11 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 Diabetes: A Real-world, Canadian Retrospective Study
- ClinicalTrials.gov ID
- NCT06962735
- Acronym / sponsor ID
- Switch CGM retro
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 8 May 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real-time continuous glucose monitoring switch group (rtCGM switch group) | – | Device: real-time continuous glucose monitoradults with diabetes that switched from an isCGM to an rtCGM |
| intermittently scanned continuous glucose monitoring group (isCGM group) | – | –adults with diabetes that remained on an isCGM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults, who were active patients with type 1 diabetes or type 2 diabetes at LMC, who switched from intermittently scanned continuous glucose monitoring to real-time continuous glucose monitoring (rtCGM switch cohort) or initiated and maintained intermittently scanned continuous glucose monitoring use (isCGM cohort).
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
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 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
13 secondary outcomes
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
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
Change in percent time below target glucose range (TBR)
Time frame: from index date to 6- to-12-month follow-up
Change in percent time above target glucose range (TAR)
Time frame: from index date to 6- to-12-month follow-up
Change in mean glucose
Time frame: from index date to 6- to-12-month follow-up
Change in standard deviation (SD) of mean glucose
Time frame: from index date to 6- to-12-month follow-up
Change in coefficient of variation (CV) of mean glucose
Time frame: from index date to 6- to-12-month follow-up
Change in weight
Time frame: from index date to 6- to-12-month follow-up
Proportion of patients who achieve HbA1c ≤7.0%
Time frame: evaluated at 6- to-12-month follow-up
Weekly incidence of self-reported hypoglycemia
Time frame: evaluated at 6- to-12-month follow-up
Proportion of patients with ≥ 1 self-reported hypoglycemic event
Time frame: evaluated at 6- to-12-month follow-up
Change in total daily dose (TDD) of insulin
Time frame: from index date to 6- to-12-month follow-up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, 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 3 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: finished, as of the sponsor's last update on 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c at 6-12-month follow-up compared to baseline (time frame: from index date to 6- to-12-month 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 11 May 2025.