Clinical trial NCT04562714: Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
Official title: IMpact of Flash Glucose Monitoring in pEople With Type 2 Diabetes Inadequately Controlled With Non-insulin Antihyperglycemic ThErapy - IMMEDIATE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Glucose
Keywords: Type 2 diabetes
Flash sensor glucose technology
Glucose monitoring
Randomized controlled trial
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
First posted: 2020-09-24
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Time in Range (TIR)
timeFrame: 2-week period
Secondary outcomes:
measure: Glycemic control (a)
timeFrame: 2-week period
measure: Glycemic control (b)
timeFrame: 2-week period
measure: Glycemic control (c)
timeFrame: 2-week period
measure: Proportion of time spent in various glycemic ranges based on blinded CGM recordings
timeFrame: 2-week period
measure: Glycemic variability
timeFrame: 2-week period
measure: Number of documented episodes of hypoglycemia episodes
timeFrame: 2-week period
measure: Number of episodes of severe hypoglycemia
timeFrame: 16-week period
measure: Adherence to diabetes medications as measured by the Adherence to Refills and Medication-Diabetes (ARMS-D)
timeFrame: 2-week period
measure: Psychological distress as measured by the Diabetes Distress Scale (DDS)
timeFrame: 2-week period
measure: Device satisfaction as measured by the Glucose Monitoring System Satisfaction Survey (GMSS)
timeFrame: 2-week period
measure: Participant self-efficacy as measured by the Skills, Confidence and Preparedness Index (SCPI)
timeFrame: 2-week period
measure: Change in antihyperglycemic therapies
timeFrame: 2-week period
measure: Change in weight (kg)
timeFrame: 16-week period
measure: Change in waist circumference (cm)
timeFrame: 16-week period
measure: Diabetes self-management education (DSME) goals setting
timeFrame: 16-week period
measure: Mean DSME goal achievement score during Phase 1
timeFrame: 16-week period
measure: Mean number of glucose checks
timeFrame: 2-week period
Other outcomes:
measure: Exploratory analysis 1a: Glucose control - Targeted glucose range
timeFrame: 16-week period
measure: Exploratory analysis 1b: Glucose control - hypoglycemia
timeFrame: 16-week period
measure: Exploratory analysis 1c: Glucose control - hyperglycemia
timeFrame: 16-week period
measure: Exploratory analysis 1d: Glucose control - HbA1c
timeFrame: 16-week period
measure: Exploratory analysis 1e: Glucose control - Mean glucose
timeFrame: 16-week period
measure: Exploratory analysis 1f: Glucose control - Glycemic variability
timeFrame: 16-week period
measure: Exploratory analysis 1g: Glucose control - Hypoglycemia
timeFrame: 16-week period
measure: Exploratory analysis 1h: Glucose control - Severe hypoglycemia
timeFrame: 16-week period
measure: Exploratory analysis 2a: Patient reported outcome - Adherence
timeFrame: 16-week period
measure: Exploratory analysis 2b: Patient reported outcome - Psychological distress
timeFrame: 16-week period
measure: Exploratory analysis 2c: Patient reported outcome - Device satisfaction
timeFrame: 16-week period
measure: Exploratory analysis 2d: Patient reported outcome - Participant self-efficacy
timeFrame: 16-week period
measure: Exploratory analysis 3a: Effect of DSME goal achievement
timeFrame: 16-week period
measure: Exploratory analysis 3b: Effect of DSME goal achievement
timeFrame: 16-week period
measure: Exploratory analysis 3c: Effect of DSME goal achievement
timeFrame: 16-week period
measure: Exploratory analysis 4: Frequency of glucose testing
timeFrame: 16-week period
Locations:
city: Brampton
country: Canada
facility: LMC Brampton
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Etobicoke
state: Ontario
city: Oakville
country: Canada
facility: LMC Oakville
state: Ontario
city: Ottawa
country: Canada
facility: LMC Ottawa
state: Ontario
city: Toronto
country: Canada
facility: LMC Midtown
state: Ontario
city: Vaughan
country: Canada
facility: LMC Vaughan/Thornhill
state: Ontario
Study officials:
affiliation: LMC Diabetes
name: Ronnie Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polonsky WH, Fisher L, Hessler D, Edelman SV. Development of a New Measure for Assessing Glucose Monitoring Device-Related Treatment Satisfaction and Quality of Life. Diabetes Technol Ther. 2015 Sep;17(9):657-63. doi: 10.1089/dia.2014.0417. Epub 2015 Apr 29.
citation: Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
citation: Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
citation: Aronson R, Li A, Brown RE, Walker A, Lyons A, Orzech N. Optimizing Diabetes Self-management Using the Novel Skills, Confidence, and Preparedness Index (SCPI). Diabetes Care. 2019 Oct;42(10):1873-1878. doi: 10.2337/dc19-0699. Epub 2019 Aug 9.