Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy (IMMEDIATE)
Diabetes Mellitus, Type 2, Glucose
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, Flash sensor glucose technology, Glucose monitoring, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
Eligible participants must be an adult aged 18 years or older and:
- A clinical diagnosis of T2D, with diagnosis known for six months or more;
- An HbA1c of > 7.5%;
- Using one or more non-insulin antihyperglycemic therapy for a minimum of six months, with dose stability of 3 months; and
- No previous history of using CGM or FGM devices.
Exclusion Criteria:
Participants will be excluded from the study if they:
- Have a history of insulin use > 3 months
- Are pregnant or breastfeeding
- Have diabetic retinopathy
- Have an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
- Have unstable cardiovascular disease
- Use other implanted medical devices, such as pacemakers
- Have had more than one episode of severe hypoglycemia during the past 6 months or evidence of hypoglycemia unawareness
- Anticipate or require regular magnetic resonance imaging, computed tomography scan, or high-frequency electrical heat (diathermy) treatment
Sites / Locations
- LMC Brampton
- LMC Etobicoke
- LMC Oakville
- LMC Ottawa
- LMC Midtown
- LMC Vaughan/Thornhill
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Intervention (FGM + DSME)
Control (DSME alone)
Study participants randomized to the intervention arm will be provided with a FreeStyle Libre flash glucose monitor (FGM) system to use for 16 weeks in Phase 1. Study participants will receive one training session on proper use of the FGM and encouraged to test at least 4 times per day: fasting and post-meals. Participants will also receive six diabetes self-management education (DSME) sessions, consisting of four individual in-clinic sessions and two telephone sessions.
Study participants in the control arm will receive six diabetes self-management education sessions matched to time and location of the intervention group. The sessions will consist of four individual in-clinic sessions and two telephone sessions over 16 weeks. Control participants will be encouraged to self-monitor blood glucose four times daily (fasting and post-meals) as per existing diabetes self-care guidelines