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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2022-09-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Glucose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The IMMEDIATE study is a two-phased, cross-over study. In Phase 1, participants will be randomized at a 1:1 ratio, stratified by use of glucagon-like peptide-1 receptor agonist to receive either a flash glucose monitor (FGM) + diabetes self-management education (DSME) (Intervention arm) or to DSME alone (Control arm). Participants randomized to the Intervention arm will receive a FreeStyle Libre FGM System, 1 training session on its proper use, and 6 DSME sessions. Participants randomized to the Control arm will receive 6 DSME sessions matched to time and location of the Intervention group. DSME sessions for both groups will consist of four individual in-clinic sessions and two telephone sessions. After 16-weeks, participants initially assigned to DSME alone will cross-over to receive the intervention FGM device, while those initially randomized to using a FGM will continue using their device for an additional 16 weeks (Phase 2). No DSME will provided during Phase 2.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The study design is open-label in which neither investigator nor study participants will be blinded to study treatment. All study participants will wear a blinded continuous glucose monitoring device for two weeks at baseline and during the final two weeks of Phase 1, during which they will be blinded to the results of the blinded glucose monitoring device.

Study Groups

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Intervention (FGM + DSME)

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.

Group Type EXPERIMENTAL

FreeStyle Libre Flash Glucose Monitor

Intervention Type DEVICE

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 education

Intervention Type OTHER

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.

Control (DSME alone)

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

Group Type OTHER

Diabetes self-management education

Intervention Type OTHER

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.

Interventions

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FreeStyle Libre Flash Glucose Monitor

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.

Intervention Type DEVICE

Diabetes self-management education

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No