Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time continuous glucose monitoring switch group (rtCGM switch group) | adults 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real-time continuous glucose monitor | Device | Individuals who switched from using isCGM to rtCGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | from enrollment to 6 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrollment to 6 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Monitoring Device Satisfaction Scale (GMSS) | includes questions about device satisfaction, filled out only by the cohort switching from isCGM to rtCGM | from enrollment to 6 months follow up |
| Diabetes Distress Scale (DDS) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
Not provided
Not provided
| 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 retrieved from a national Diabetes Registry. IPD will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | from enrollment to 6 months follow up |
includes questions about psychological distress , filled out only by the cohort switching from isCGM to rtCGM
| from enrollment to 6 months follow up |
| Protocol-Specific Dexcom Care Survey | includes protocol-specific questions about rtCGM device, filled out only by the cohort switching from isCGM to rtCGM | 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 |
Not provided
Not provided