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| Name | Class |
|---|---|
| Abbott Diabetes Care | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (FGM + DSME) | Experimental | 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. |
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| Control (DSME alone) | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre Flash Glucose Monitor | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2-week period |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control (a) | Mean HbA1c (blood drawn for laboratory testing) at the end of Phase 1 | 2-week period |
| Glycemic control (b) | Proportion of participants with HbA1c < 7.0% and with HbA1c > 9.0% at the end of Phase 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analysis 1a: Glucose control - Targeted glucose range | 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 | 16-week period |
| Exploratory analysis 1b: Glucose control - hypoglycemia |
Inclusion Criteria:
Eligible participants must be an adult aged 18 years or older and:
Exclusion Criteria:
Participants will be excluded from the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Aronson, MD | LMC Diabetes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Brampton | Brampton | Ontario | L6S 0C6 | Canada | ||
| LMC Etobicoke |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25923812 | Background | 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. | |
| 24209600 | Background | 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. |
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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.
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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.
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| Diabetes self-management education | Other | The DSME curriculum is compromised of:
|
|
| 2-week period |
| Glycemic control (c) | Mean glucose based on blinded CGM recordings at the end of Phase 1 | 2-week period |
| Proportion of time spent in various glycemic ranges based on blinded CGM recordings |
| 2-week period |
| Glycemic variability | Standard deviation and % coefficient of variation based on blinded CGM recordings | 2-week period |
| Number of documented episodes of hypoglycemia episodes | Based on the blinded CGM recording, including:
| 2-week period |
| Number of episodes of severe hypoglycemia | A hypoglycemic episode that requires assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions as reported by participant | 16-week period |
| Adherence to diabetes medications as measured by the Adherence to Refills and Medication-Diabetes (ARMS-D) | 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) | 2-week period |
| Psychological distress as measured by the Diabetes Distress Scale (DDS) | 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. | 2-week period |
| Device satisfaction as measured by the Glucose Monitoring System Satisfaction Survey (GMSS) | 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) | 2-week period |
| Participant self-efficacy as measured by the Skills, Confidence and Preparedness Index (SCPI) | 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) | 2-week period |
| Change in antihyperglycemic therapies | Change in the mean number of antihyperglycemic therapies from baseline to end of | 2-week period |
| Change in weight (kg) | Change in weight (kg) from baseline to end of Phase 1 | 16-week period |
| Change in waist circumference (cm) | Change in waist circumference (cm) from baseline to end of Phase 1 | 16-week period |
| Diabetes self-management education (DSME) goals setting | Mean number of diabetes self-management education (DSME) goals set per person | 16-week period |
| Mean DSME goal achievement score during Phase 1 | 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). | 16-week period |
| Mean number of glucose checks | Mean number of FGM scans for the intervention group; and mean number of self-monitoring of blood glucose for the control arm | 2-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 |
| 16-week period |
| Exploratory analysis 1c: Glucose control - hyperglycemia | 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 | 16-week period |
| Exploratory analysis 1d: Glucose control - HbA1c | 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 | 16-week period |
| Exploratory analysis 1e: Glucose control - Mean glucose | Within group change in mean glucose based on FGM metrics from the first 2-week and final 2-week periods of Phase 2 | 16-week period |
| Exploratory analysis 1f: Glucose control - Glycemic variability | 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 | 16-week period |
| Exploratory analysis 1g: Glucose control - Hypoglycemia | 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 | 16-week period |
| Exploratory analysis 1h: Glucose control - Severe hypoglycemia | 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 | 16-week period |
| Exploratory analysis 2a: Patient reported outcome - Adherence | Within group change in the Adherence to Refills and Medication-Diabetes (ARMS-D) from the beginning to the end of Phase 2 | 16-week period |
| Exploratory analysis 2b: Patient reported outcome - Psychological distress | Within group change in the Diabetes Distress Scale from the beginning to the end of Phase 2. | 16-week period |
| Exploratory analysis 2c: Patient reported outcome - Device satisfaction | Within group change in the Glucose Monitoring System Satisfaction Survey from the | 16-week period |
| Exploratory analysis 2d: Patient reported outcome - Participant self-efficacy | Within group change in the Skills, Confidence and Preparedness Index (SCPI) from the beginning to the end of Phase 2. | 16-week period |
| Exploratory analysis 3a: Effect of DSME goal achievement | 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 | 16-week period |
| Exploratory analysis 3b: Effect of DSME goal achievement | 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 | 16-week period |
| Exploratory analysis 3c: Effect of DSME goal achievement | 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. | 16-week period |
| Exploratory analysis 4: Frequency of glucose testing | The optimal frequency of glucose testing for greatest impact on glycemic control (TIR) | 16-week period |
| Etobicoke |
| Ontario |
| M9R 4E1 |
| Canada |
| LMC Oakville | Oakville | Ontario | L6M 1M1 | Canada |
| LMC Ottawa | Ottawa | Ontario | K2J 0V2 | Canada |
| LMC Midtown | Toronto | Ontario | M4G 3E8 | Canada |
| LMC Vaughan/Thornhill | Vaughan | Ontario | L4K 4M2 | Canada |
| 15735199 | Background | 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. |
| 31399439 | Background | 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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