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

LMC Diabetes & Endocrinology Ltd.

Status: Completed

Conditions: Glucose; Diabetes Mellitus, Type 2

Treatments: Device: FreeStyle Libre Flash Glucose Monitor; Other: Diabetes self-management education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04562714

IMMEDIATE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Intervention (FGM + DSME)

Experimental group

Description:

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.

Treatment:

Device: FreeStyle Libre Flash Glucose Monitor

Other: Diabetes self-management education

Control (DSME alone)

Other group

Description:

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

Treatment:

Other: Diabetes self-management education