An observational study in Type 2 Diabetes, sponsored by LMC Diabetes & Endocrinology Ltd.. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by LMC Diabetes & Endocrinology Ltd. · Observational
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 specialist endocrinology clinical setting in Canada.
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%).
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 250 is close to the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →LMC Diabetes & Endocrinology Ltd. is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
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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)
Exclusion Criteria:
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
Device: Intermittently Scanned Continuous Glucose Monitor
Adults with T2D, who are active patients at LMC, not using insulin and use a CBG monitor
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
Device: Intermittently Scanned Continuous Glucose Monitor
intervention used by the isCGM and isCGM+Coaching groups
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
Time frame: from enrollment to 3-6 month follow up
Change in Weight
Evaluate the change in weight in the isCGM and CBG cohorts
Time frame: 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
Time frame: from enrollment to 3-6 month follow up
Change in Blood Pressure
Evaluate the change in blood pressure in the isCGM and CBG cohorts
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from enrollment to 3-6 month follow up
Mean glucose
Evaluate mean glucose in the isCGM and isCGM+Coaching cohorts
Time frame: 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
Time frame: from enrollment to 3-6 month follow up
Percent sensor capture
Evaluate percent sensor capture in the isCGM and isCGM+Coaching cohorts
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: assessed at 3-6 month follow-up
Change in Weight
Evaluate change in weight in only the isCGM+Coaching cohort
Time frame: 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
Time frame: from enrollment to 3-6 month follow up
Change in Blood Pressure
Evaluate Change in Blood Pressure in only the isCGM+Coaching cohort
Time frame: 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
Time frame: from enrollment to 3-6 month follow up
Change in HbA1c by Age
Evaluate change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D by age \< 65 years old vs ≥ 65 years old subgroups
Time frame: assessed at 3-6 month follow-up
Change in HbA1c by Baseline HbA1c
Evaluate change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D by baseline HbA1c (\< 8.5% vs ≥ 8.5% subgroups)
Time frame: assessed at 3-6 month follow-up
Plan to share: No — This is a real-world study using data from a national Diabetes Registry. IPD will not be shared.
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LMC Diabetes & Endocrinology Ltd.