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

LMC Diabetes & Endocrinology Ltd.116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Diabetes Mellitus, Type 2 Glucose

Interventions

FreeStyle Libre Flash Glucose MonitorDEVICE

The FreeStyle Libre FGM device consists of a skin-worn disposable sensor that automatically measures and continuously stores glucose readings. The sensor is placed by a single-use applicator and is activated by a wireless scan with a handheld reader. It is designed to stay on the body for up to 14 days, and can be worn under clothing. After a 1-hour warm-up period, the sensor takes automatic measurements of glucose every 15 minutes for up to 14 days. The device collects the interstitial glucose values and stores them for subsequent upload at the end of the 14-day wear period. With each scan, users receive their glucose reading; the last eight hours of glucose data; and an arrow illustrating the direction their glucose is heading.

Diabetes self-management educationOTHER

The DSME curriculum is compromised of: 1. Review of weekly glucose report (Trend glucose report from Libreview for intervention group; and weekly glucose report in log book format from their glucose monitoring software for control group) 2. Education modules for both in-person and remote delivery; 3. Handouts to support the curriculum objectives; and 4. Blood glucose monitoring challenges to stimulate behaviour change and reinforce learning.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

LMC Brampton

Brampton, Ontario, Canada

LMC Etobicoke

Etobicoke, Ontario, Canada

LMC Oakville

Oakville, Ontario, Canada

LMC Ottawa

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

Time in Range (TIR)

The proportion of time within target glucose range (3.9 to 10.0 mmol/L) among adults with type 2 diabetes (T2D) inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using an FGM device measured during the blinded continuous glucose monitor (CGM) period during the final last two-weeks of the Phase 1

Time frame: 2-week period

Secondary Outcomes

Glycemic control (a)

Mean HbA1c (blood drawn for laboratory testing) at the end of Phase 1

Time frame: 2-week period

Glycemic control (b)

Proportion of participants with HbA1c \< 7.0% and with HbA1c \> 9.0% at the end of Phase 1

Time frame: 2-week period

Glycemic control (c)

Mean glucose based on blinded CGM recordings at the end of Phase 1

Time frame: 2-week period

Proportion of time spent in various glycemic ranges based on blinded CGM recordings

* Tight glycemic range (3.9 to 7.8 mmol/L) * Hypoglycemia range (3.0 to 3.8 mmol/L) * Clinically significant (level 2) hypoglycemia range (\< 3.0 mmol/L) * Hyperglycemia (\> 10.0 mmol/L)

Time frame: 2-week period

Glycemic variability

Standard deviation and % coefficient of variation based on blinded CGM recordings

Time frame: 2-week period

Number of documented episodes of hypoglycemia episodes

Based on the blinded CGM recording, including: * All (hypoglycemic episode occurring at anytime); * Nocturnal (hypoglycemic episode occurring between 12 am and 6 am); and * Level 2 hypoglycemic (\<3.9 mmol/L)

Data from ClinicalTrials.gov

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