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| Name | Class |
|---|---|
| Sun Life Assurance Company of Canada | UNKNOWN |
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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittently Scanned Continuous Glucose Monitor | Device | intervention used by the isCGM and isCGM+Coaching groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from enrollment to 3-6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Evaluate the change in weight in the isCGM and CBG cohorts | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | assessed at 3-6 month follow-up |
| Change in HbA1c by Baseline HbA1c |
Inclusion Criteria:
Exclusion Criteria:
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Diabetes & Endocrinology Ltd. | Recruiting | Toronto | Ontario | M4G 3E8 | Canada |
This is a real-world study using data from a national Diabetes Registry. IPD will not be shared.
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| from enrollment to 3-6 month follow up |
| Change in Blood Pressure | Evaluate the change in blood pressure in the isCGM and CBG cohorts | 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 | 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 | 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 | 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 | 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 | 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 | 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 | from enrollment to 3-6 month follow up |
| Mean glucose | Evaluate mean glucose in the isCGM and isCGM+Coaching cohorts | 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 | from enrollment to 3-6 month follow up |
| Percent sensor capture | Evaluate percent sensor capture in the isCGM and isCGM+Coaching cohorts | 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 | 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 | 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 | 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 | 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 | assessed at 3-6 month follow-up |
| Change in Weight | Evaluate change in weight in only the isCGM+Coaching cohort | 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 | from enrollment to 3-6 month follow up |
| Change in Blood Pressure | Evaluate Change in Blood Pressure in only the isCGM+Coaching cohort | 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 | from enrollment to 3-6 month follow up |
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) |
| assessed at 3-6 month follow-up |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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