Diabetes Mellitus, Type 2, Glucose
Conditions
Keywords
Type 2 diabetes, Flash sensor glucose technology, Glucose monitoring, Randomized controlled trial
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.
Interventions
DEVICEFreeStyle 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.
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.
Sponsors
Abbott Diabetes Care
LMC Diabetes & Endocrinology Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control (b) | 2-week period | Proportion of participants with HbA1c \< 7.0% and with HbA1c \> 9.0% at the end of Phase 1 |
| Glycemic control (a) | 2-week period | Mean HbA1c (blood drawn for laboratory testing) at the end of Phase 1 |
| Glycemic control (c) | 2-week period | Mean glucose based on blinded CGM recordings 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) |
| Glycemic variability | 2-week period | Standard deviation and % coefficient of variation based on blinded CGM recordings |
| 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) |
| 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) |
| 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. |
| 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) |
| Change in antihyperglycemic therapies | 2-week period | Change in the mean number of antihyperglycemic therapies from baseline to end of |
| 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 |
| Diabetes self-management education (DSME) goals setting | 16-week period | Mean number of diabetes self-management education (DSME) goals set per person |
| 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). |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory analysis 1c: Glucose control - hyperglycemia | 16-week period | Within group change in the proportion of time spent in hyperglycemia (\>10 mmol/L) range based on FGM metrics from the first 2-weeks and final 2-week periods of Phase 2 |
| Exploratory analysis 1d: Glucose control - HbA1c | 16-week period | Within group change in HbA1c based on blood drawn for laboratory testing from the first 2-week and the final 2-week periods of Phase 2 |
| Exploratory analysis 1e: Glucose control - Mean glucose | 16-week period | Within group change in mean glucose based on FGM metrics from the first 2-week and final 2-week periods of Phase 2 |
| Exploratory analysis 1f: Glucose control - Glycemic variability | 16-week period | Within group change in standard deviation and % coefficient of variation based on FGM metrics from the first 2-week and final 2-week periods of Phase 2 |
| Exploratory analysis 1g: Glucose control - Hypoglycemia | 16-week period | Within group change in the frequency of hypoglycemia based on FGM metrics from the first 2-week and final 2-week periods of Phase 2 |
| Exploratory analysis 1h: Glucose control - Severe hypoglycemia | 16-week period | Within group change in the frequency of severe hypoglycemia, defined as a hypoglycemic episode that required assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions, based on FGM metrics from the first 2-week and final 2-week periods of Phase 2 |
| Exploratory analysis 2a: Patient reported outcome - Adherence | 16-week period | Within group change in the Adherence to Refills and Medication-Diabetes (ARMS-D) from the beginning to the end of Phase 2 |
| Exploratory analysis 2b: Patient reported outcome - Psychological distress | 16-week period | Within group change in the Diabetes Distress Scale from the beginning to the end of Phase 2. |
| Exploratory analysis 2c: Patient reported outcome - Device satisfaction | 16-week period | Within group change in the Glucose Monitoring System Satisfaction Survey from the |
| Exploratory analysis 2d: Patient reported outcome - Participant self-efficacy | 16-week period | Within group change in the Skills, Confidence and Preparedness Index (SCPI) from the beginning to the end of Phase 2. |
| Exploratory analysis 3a: Effect of DSME goal achievement | 16-week period | The effect of DSME goal achievement, independent of glucose monitoring system used, on the change in proportion of time spent in targeted glucose range in the final 2-week CGM period of Phase 1 vs baseline |
| Exploratory analysis 3b: Effect of DSME goal achievement | 16-week period | The effect of DSME goal achievement, independent of glucose monitoring system used, on the frequency of FGM-measured hypoglycemia in the final 2-week CGM period of Phase 1 vs baseline |
| Exploratory analysis 3c: Effect of DSME goal achievement | 16-week period | The effect of DSME goal achievement, independent of glucose monitoring system used, on the association between the daily frequency of FGM scanning/self-monitored blood glucose and TIR. |
| Exploratory analysis 4: Frequency of glucose testing | 16-week period | The optimal frequency of glucose testing for greatest impact on glycemic control (TIR) |
| Exploratory analysis 1b: Glucose control - hypoglycemia | 16-week period | Within group change in the proportion of time spent in hypoglycemia (\<3.8 mmol/L) ranged based on FGM metrics from the first 2-week and the final 2-week periods of Phase 2 |
| Exploratory analysis 1a: Glucose control - Targeted glucose range | 16-week period | Within group change in the proportion of time spent in targeted glucose range based on FGM metrics from the first 2-week and final 2-week periods of Phase 2 |
Countries
Canada
Outcome results
None listed