Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)

LMC Diabetes & Endocrinology Ltd.

Status

Enrolling

Conditions

Type 2 Diabetes

Treatments

Device: real-time continuous glucose monitor

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06805786

Switch CGM T2D

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older
Clinical diagnosis of T2D ≥ one year
Using insulin for ≥ 6 months
Continued FreeStyle Libre® 2 isCGM device (isCGM cohort) as of the study start date
Would like to switch from a FreeStyle Libre® 2 isCGM device to a Dexcom® G7 rtCGM device (rtCGM switch cohort) as of the study start date
Baseline HbA1c ≥ 7.5%
Known rtCGM/isCGM start date (month and year)
Exclusive use of isCGM for ≥ 3 months
Data on LibreView platforms have percent sensor capture ≥ 70% for 14 days of available data up to 6 months prior to index date
≥ 1 value for TIR (%) up to 6 months (± 6 weeks) prior to index date
≥ 1 value for HbA1c (%) up to 6 months (± 6 weeks) prior to index date
Data consent

Exclusion criteria

Have a prior history of rtCGM within 12 months of the index date
Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
Recent or expectant titration of insulin dose ≥ 20% within 30 days of index date
Are pregnant at the time of study enrollment or intending to become pregnant during the study
Used the isCGM or rtCGM for < 3 months
Using continuous subcutaneous insulin infusion