Type 2 DiabetesREAL isCGM T2DNCT06837103

Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Not Using Insulin (REAL isCGM T2D)

An observational study of Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The goal of this prospective study is to evaluate diabetes outcomes after initiating second generation intermittently scanned continuous glucose monitoring (isCGM) plus one pharmacist consultation session compared with capillary blood glucose (CBG) monitoring among insulin-naïve adults with type 2 diabetes (T2D) in a… 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?: Intermittently Scanned Continuous Glucose Monitor
Type of treatment: Medical device
How many people: 250 participants
Where: 1 siteCanada
Study dates: 9 Apr 2025to May 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 with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete one initial pharmacist consultation (isCGM cohort) or complete 2 or more diabetes coaching program consultations (isCGM+coaching cohort), or use a CBG monitor (CBG cohort)

Who may be able to join

18 years or older
Clinical diagnosis of T2D ≥ one year
Using at least one AHA
Status as a Sun Life group benefits member, initiates isCGM device through Lumino Health™ Pharmacy, and completes one initial pharmacist consultation (isCGM cohort) or completes 2 or more diabetes coaching program consultations (isCGM+coaching cohort); or has private health insurance and uses CBG monitoring (CBG cohort)
Baseline HbA1c ≥ 7.0%
≥ 1 HbA1c value up to 6 months prior to index date
Exclusive use of isCGM for ≥ 3 months
Informed consent

Who cannot join

Have a history of insulin use
Are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study
Have an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
Previously used rtCGM or isCGM for > 3 months
Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date

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

LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, M4G 3E8
Manager, Data Science, 4166452929, lisa.chu@lmc.ca
Research Assistant, Data Science, giovana.romero@lmc.ca
Recruiting

Other trials in Canada

About this study

Official title: Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Using Non-insulin Antihyperglycemic Agents

Primary Outcome - To evaluate change in HbA1c at 3-6 months follow-up after initiating isCGM plus one pharmacist consultation (isCGM cohort) compared with CBG monitoring (CBG cohort) among insulin-naïve adults with T2D.

Secondary Outcomes - To determine the change in metabolic outcomes and patient reported outcomes (PROs) and number of non-insulin antihyperglycemic agents (AHAs) prescribed from baseline to 3-6 months (± 6 weeks) in the isCGM cohort compared to the CBG cohort. Another secondary outcome is to assess isCGM metrics and number of isCGM discontinuations in the isCGM cohort at 3-6 months (± 6 weeks) compared to baseline. Additionally the study will describe and/or evaluate glycemic and metabolic outcomes, and PROs in participants who initiate an isCGM device and opt to enroll in a diabetes coaching program (isCGM+coaching cohort) at baseline compared to follow-up at 3-6 months (± 6 weeks).

Exploratory Outcomes - To compare change in HbA1c between the matched isCGM cohort and CBG cohort by subgroups: age (< 65 years old vs ≥ 65 years old) and baseline HbA1c (< 8.5% vs ≥ 8.5%).

Conditions: Type 2 Diabetes
Being tested: Intermittently Scanned Continuous Glucose Monitor
Keywords: continuous glucose monitoring, type 2 diabetes, time in range, HbA1c
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.

Intermittently Scanned Continuous Glucose MonitorDevice
intervention used by the isCGM and isCGM+Coaching groups

Study groups in NCT06837103
Study group	Role	What they receive
isCGM Group		Adults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete one initial pharmacist consultation Receives: Device: Intermittently Scanned Continuous Glucose Monitor
CBG Group		Adults with T2D, who are active patients at LMC, not using insulin and use a CBG monitor
isCGM+Coaching Group		Adults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete 2 or more diabetes coaching program consultations Receives: Device: Intermittently Scanned Continuous Glucose Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
Evaluate the change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D
Measured: from enrollment to 3-6 month follow up

Secondary outcomes (22)

Change in Weight
Evaluate the change in weight in the isCGM and CBG cohorts
Measured: from enrollment to 3-6 month follow up
Change in BMI
Evaluate the change in body mass index (BMI) in the isCGM and CBG cohorts
Measured: from enrollment to 3-6 month follow up
Change in Blood Pressure
Evaluate the change in blood pressure in the isCGM and CBG cohorts
Measured: from enrollment to 3-6 month follow up
Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up
Evaluate the proportion of participants achieving HbA1c ≤ 7.0% at follow-up in the isCGM and CBG cohort
Measured: from enrollment to 3-6 month follow up
Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week
Evaluate the proportion of participants with ≥1 self-reported hypoglycemic event per week in the isCGM and CBG cohort
Measured: from enrollment to 3-6 month follow up
Percent Time in Range (TIR)
Evaluate percent time in range (3.9 to 10.0 mmol/L) in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Percent Time Below Range (TBR)
Evaluate percent time below range (< 3.9 mmol/L) in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Percent Time Below Range (TBR) in Level 2 Hypoglycemia
Evaluate Percent TBR in level 2 hypoglycemia (< 3.0 mmol/L) in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Percent Time Above Range (TAR)
Evaluate Percent TAR (> 10.0 mmol/L) in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Estimated Glucose Management Indicator (eGMI)
Evaluate the Estimated Glucose Management Indicator (eGMI) in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Mean glucose
Evaluate mean glucose in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Glycemic variability
Evaluate glycemic variability reported as SD and CV in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Percent sensor capture
Evaluate percent sensor capture in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Number of isCGM discontinuations
Evaluate the number of isCGM discontinuations in the isCGM and isCGM+Coaching cohorts only at follow-up
Measured: assessed at 3-6 month follow-up
Number of diabetes coaching program discontinuations
Evaluate the number of diabetes coaching program discontinuations, measured by the Diabetes Coaching Program survey in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Psychological distress
Evaluate psychological distress measured by the Diabetes Distress Scale (DDS) in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Glucose monitoring device satisfaction
Evaluate glucose monitoring device satisfaction measured by the Glucose Monitoring System Satisfaction Scale (GMSS) in the isCGM and isCGM+Coaching cohorts
Measured: from enrollment to 3-6 month follow up
Proportion of participants achieving HbA1c ≤ 7.0%
Evaluate proportion of participants achieving HbA1c ≤ 7.0% in the isCGM and isCGM+Coaching cohorts at follow-up only
Measured: assessed at 3-6 month follow-up
Change in Weight
Evaluate change in weight in only the isCGM+Coaching cohort
Measured: from enrollment to 3-6 month follow up
Change in Body Mass Index (BMI)
Evaluate the change in body mass index in only the isCGM+Coaching cohort
Measured: from enrollment to 3-6 month follow up
Change in Blood Pressure
Evaluate Change in Blood Pressure in only the isCGM+Coaching cohort
Measured: from enrollment to 3-6 month follow up
Proportion of participants with ≥1 self-reported hypoglycemic event per week
Evaluate the proportion of participants with ≥1 self-reported hypoglycemic event per week in the isCGM+Coaching cohort only
Measured: from enrollment to 3-6 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 2025May 2026

First posted20 Feb 2025
Study start9 Apr 2025
Primary completionMay 2026 (estimated)
Study completionMay 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: 250 participants (estimated)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT06837103
Sponsor's protocol ID: REAL isCGM T2D
Acronym: REAL isCGM T2D
Status last verified: Apr 2025
First submitted: 29 Jan 2025
Last updated: 4 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: This is a real-world study using data from a national Diabetes Registry. IPD will not be shared.

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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All Type 2 Diabetes trials

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: Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Using Non-insulin Antihyperglycemic Agents
ClinicalTrials.gov ID: NCT06837103
Acronym / sponsor ID: REAL isCGM T2D / REAL isCGM T2D
Conditions: Type 2 Diabetes
Keywords: continuous glucose monitoring, type 2 diabetes, time in range, HbA1c
Study type: Observational
Recruitment status: Recruiting
Enrolment: 250 participants (estimated)
Lead sponsor: LMC Diabetes & Endocrinology Ltd.University, hospital or other
Collaborators: Sun Life Assurance Company of Canada
Study start: 9 Apr 2025 (actual)
Primary completion: May 2026 (estimated)
Study completion: May 2026 (estimated)
First posted: 20 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.

Exploratory Outcomes - To compare change in HbA1c between the matched isCGM cohort and CBG cohort by subgroups: age (< 65 years old vs ≥ 65 years old) and baseline HbA1c (< 8.5% vs ≥ 8.5%).

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 6 Months
Number of arms: 3

Arm	Type	Receives
isCGM Group	–	Device: Intermittently Scanned Continuous Glucose MonitorAdults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete one initial pharmacist consultation
CBG Group	–	–Adults with T2D, who are active patients at LMC, not using insulin and use a CBG monitor
isCGM+Coaching Group	–	Device: Intermittently Scanned Continuous Glucose MonitorAdults with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete 2 or more diabetes coaching program consultations

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 with T2D, who are active patients at LMC, not using insulin, and initiate a second generation isCGM device through Lumino Health™ Pharmacy, and complete one initial pharmacist consultation (isCGM cohort) or complete 2 or more diabetes coaching program consultations (isCGM+coaching cohort), or use a CBG monitor (CBG cohort)

Key inclusion criteria (8 listed)

18 years or older
Clinical diagnosis of T2D ≥ one year
Using at least one AHA
Status as a Sun Life group benefits member, initiates isCGM device through Lumino Health™ Pharmacy, and completes one initial pharmacist consultation (isCGM cohort) or completes 2 or more diabetes coaching program consultations (isCGM+coaching cohort); or has private health insurance and uses CBG monitoring (CBG cohort)
Baseline HbA1c ≥ 7.0%

Key exclusion criteria (5 listed)

Have a history of insulin use
Are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study
Have an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
Previously used rtCGM or isCGM for > 3 months
Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date

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
Intermittently Scanned Continuous Glucose Monitorintervention used by the isCGM and isCGM+Coaching groups	Device	isCGM Group, isCGM+Coaching Group

Primary outcome

Change in HbA1c
Time frame: from enrollment to 3-6 month follow up
Evaluate the change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D

22 secondary outcomes

Change in Weight
Time frame: from enrollment to 3-6 month follow up
Change in BMI
Time frame: from enrollment to 3-6 month follow up
Change in Blood Pressure
Time frame: from enrollment to 3-6 month follow up
Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up
Time frame: from enrollment to 3-6 month follow up
Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week
Time frame: from enrollment to 3-6 month follow up
Percent Time in Range (TIR)
Time frame: from enrollment to 3-6 month follow up
Percent Time Below Range (TBR)
Time frame: from enrollment to 3-6 month follow up
Percent Time Below Range (TBR) in Level 2 Hypoglycemia
Time frame: from enrollment to 3-6 month follow up
Percent Time Above Range (TAR)
Time frame: from enrollment to 3-6 month follow up
Estimated Glucose Management Indicator (eGMI)
Time frame: from enrollment to 3-6 month follow up
Mean glucose
Time frame: from enrollment to 3-6 month follow up
Glycemic variability
Time frame: from enrollment to 3-6 month follow up
Percent sensor capture
Time frame: from enrollment to 3-6 month follow up
Number of isCGM discontinuations
Time frame: assessed at 3-6 month follow-up
Number of diabetes coaching program discontinuations
Time frame: from enrollment to 3-6 month follow up
Psychological distress
Time frame: from enrollment to 3-6 month follow up
Glucose monitoring device satisfaction
Time frame: from enrollment to 3-6 month follow up
Proportion of participants achieving HbA1c ≤ 7.0%
Time frame: assessed at 3-6 month follow-up
Change in Weight
Time frame: from enrollment to 3-6 month follow up
Change in Body Mass Index (BMI)
Time frame: from enrollment to 3-6 month follow up
Change in Blood Pressure
Time frame: from enrollment to 3-6 month follow up
Proportion of participants with ≥1 self-reported hypoglycemic event per week
Time frame: from enrollment to 3-6 month 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 from a national Diabetes Registry. IPD will not be shared.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

LMC Diabetes & Endocrinology Ltd.

Toronto, Canada

4166452929

lisa.chu@lmc.ca

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 8 inclusion and 5 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 HbA1c (time frame: from enrollment to 3-6 month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06837103.

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.