Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
- Conditions
- GlucoseDiabetes Mellitus, Type 2
- Registration Number
- NCT04562714
- Lead Sponsor
- LMC Diabetes & Endocrinology Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Time in Range (TIR) 2-week period 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
- Secondary Outcome Measures
Name Time Method Mean DSME goal achievement score during Phase 1 16-week period Each DSME goal set during the trial is be graded on a 6-point rating scale. Goal attainment scores range from 1 (goal not attempted) to 6 (exceeded expectation).
Device satisfaction as measured by the Glucose Monitoring System Satisfaction Survey (GMSS) 2-week period The GMSS is a 15-item self-reported measure of glucose device satisfaction. The GMSS provides a comprehensive profile of key contributors to device satisfaction. The GMSS has shown good criterion validity against the World Health Organization-5 measure of quality of life and the DDS, and the Self-Monitoring Blood Glucose (SMBG) Obstacles scale (all p \< 0.001)
Participant self-efficacy as measured by the Skills, Confidence and Preparedness Index (SCPI) 2-week period The SCPI is a 23-item scale that includes three subscales: Skills; confidence; and preparedness. Each question contains a 7-point Likert scale response. The SCPI has been demonstrated to have high validity internal consistency and test-retest reliability, with no floor or ceiling effect. Furthermore, SCPI scores are significantly correlated with HbA1c in both type 1 diabetes and T2D populations (p \< 0.001)
Diabetes self-management education (DSME) goals setting 16-week period Mean number of diabetes self-management education (DSME) goals set per person
Glycemic control (c) 2-week period Mean glucose based on blinded CGM recordings at the end of Phase 1
Glycemic variability 2-week period Standard deviation and % coefficient of variation based on blinded CGM recordings
Number of episodes of severe hypoglycemia 16-week period A hypoglycemic episode that requires assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions as reported by participant
Adherence to diabetes medications as measured by the Adherence to Refills and Medication-Diabetes (ARMS-D) 2-week period The ARMS-D is an 11-item self-reported measure of adherence that assesses one's ability to take and refill medication under different circumstances, and identifies barriers to medication adherence. The ARMS-D demonstrates good internal consistency, reliability (α=0.86), shows good convergent validity with other adherence to medication scales, and independently predicts HbA1c (β=0.16, p\<0.01)
Change in weight (kg) 16-week period Change in weight (kg) from baseline to end of Phase 1
Change in waist circumference (cm) 16-week period Change in waist circumference (cm) from baseline to end of Phase 1
Glycemic control (b) 2-week period Proportion of participants with HbA1c \< 7.0% and with HbA1c \> 9.0% at the end of Phase 1
Proportion of time spent in various glycemic ranges based on blinded CGM recordings 2-week period * 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)Number of documented episodes of hypoglycemia episodes 2-week period 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)Psychological distress as measured by the Diabetes Distress Scale (DDS) 2-week period The DDS is a 17-item scale that captures four dimensions of distress: emotional burden, regime distress, interpersonal distress and physician distress. The DDS list potential problem areas that people with diabetes may experience. Respondents are asked to indicate the degree to which each problem may be bothering them in their life on a 6-point Likert Scale from 1 (not a problem) to 6 (a very serious problem). The DDS and its subscales has been shown to have good internal reliability (α \> 0.87) and validity.
Change in antihyperglycemic therapies 2-week period Change in the mean number of antihyperglycemic therapies from baseline to end of
Mean number of glucose checks 2-week period Mean number of FGM scans for the intervention group; and mean number of self-monitoring of blood glucose for the control arm
Glycemic control (a) 2-week period Mean HbA1c (blood drawn for laboratory testing) at the end of Phase 1
Trial Locations
- Locations (6)
LMC Brampton
🇨🇦Brampton, Ontario, Canada
LMC Etobicoke
🇨🇦Etobicoke, Ontario, Canada
LMC Oakville
🇨🇦Oakville, Ontario, Canada
LMC Ottawa
🇨🇦Ottawa, Ontario, Canada
LMC Midtown
🇨🇦Toronto, Ontario, Canada
LMC Vaughan/Thornhill
🇨🇦Vaughan, Ontario, Canada
LMC Brampton🇨🇦Brampton, Ontario, Canada