Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy

IMpact of Flash Glucose Monitoring in pEople With Type 2 Diabetes Inadequately Controlled With Non-insulin Antihyperglycemic ThErapy - IMMEDIATE Study

The objective of this study is to evaluate the effectiveness of a flash glucose monitor device in achieving optimal glycemic control among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy.

The IMMEDIATE study is a multi-centre, randomized controlled, open-label, two-phase cross-over study evaluating the effectiveness of a flash glucose monitor device to increase the proportion of time spent in target glucose range (3.9 to 10.0 mmol/L) among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using a flash glucose monitor device. The study will consist of two phases; each 16 weeks long. In Phase 1, study participants who meet eligibility criteria will be randomized to receive a flash glucose monitor device combined with diabetes self-management education, or diabetes self-management education alone. In Phase 2, participants initially assigned to receive education alone will crossover to receive a flash glucose monitor device while participants initially using the flash glucose monitor will continue using their device. No diabetes self-management education will be provided during Phase 2.

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