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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562714
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Glucose Device: FreeStyle Libre Flash Glucose Monitor Other: Diabetes self-management education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
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.
Primary Purpose: Treatment
Official Title: IMpact of Flash Glucose Monitoring in pEople With Type 2 Diabetes Inadequately Controlled With Non-insulin Antihyperglycemic ThErapy - IMMEDIATE Study
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Other: 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.

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
Other: 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.




Primary Outcome Measures :
  1. Time in Range (TIR) [ Time Frame: 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 :
  1. Glycemic control (a) [ Time Frame: 2-week period ]
    Mean HbA1c (blood drawn for laboratory testing) at the end of Phase 1

  2. Glycemic control (b) [ Time Frame: 2-week period ]
    Proportion of participants with HbA1c < 7.0% and with HbA1c > 9.0% at the end of Phase 1

  3. Glycemic control (c) [ Time Frame: 2-week period ]
    Mean glucose based on blinded CGM recordings at the end of Phase 1

  4. Proportion of time spent in various glycemic ranges based on blinded CGM recordings [ Time Frame: 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)

  5. Glycemic variability [ Time Frame: 2-week period ]
    Standard deviation and % coefficient of variation based on blinded CGM recordings

  6. Number of documented episodes of hypoglycemia episodes [ Time Frame: 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)

  7. Number of episodes of severe hypoglycemia [ Time Frame: 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

  8. Adherence to diabetes medications as measured by the Adherence to Refills and Medication-Diabetes (ARMS-D) [ Time Frame: 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)

  9. Psychological distress as measured by the Diabetes Distress Scale (DDS) [ Time Frame: 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.

  10. Device satisfaction as measured by the Glucose Monitoring System Satisfaction Survey (GMSS) [ Time Frame: 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)

  11. Participant self-efficacy as measured by the Skills, Confidence and Preparedness Index (SCPI) [ Time Frame: 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)

  12. Change in antihyperglycemic therapies [ Time Frame: 2-week period ]
    Change in the mean number of antihyperglycemic therapies from baseline to end of

  13. Change in weight (kg) [ Time Frame: 16-week period ]
    Change in weight (kg) from baseline to end of Phase 1

  14. Change in waist circumference (cm) [ Time Frame: 16-week period ]
    Change in waist circumference (cm) from baseline to end of Phase 1

  15. Diabetes self-management education (DSME) goals setting [ Time Frame: 16-week period ]
    Mean number of diabetes self-management education (DSME) goals set per person

  16. Mean DSME goal achievement score during Phase 1 [ Time Frame: 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).

  17. Mean number of glucose checks [ Time Frame: 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 Outcome Measures:
  1. Exploratory analysis 1a: Glucose control - Targeted glucose range [ Time Frame: 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

  2. Exploratory analysis 1b: Glucose control - hypoglycemia [ Time Frame: 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

  3. Exploratory analysis 1c: Glucose control - hyperglycemia [ Time Frame: 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

  4. Exploratory analysis 1d: Glucose control - HbA1c [ Time Frame: 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

  5. Exploratory analysis 1e: Glucose control - Mean glucose [ Time Frame: 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

  6. Exploratory analysis 1f: Glucose control - Glycemic variability [ Time Frame: 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

  7. Exploratory analysis 1g: Glucose control - Hypoglycemia [ Time Frame: 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

  8. Exploratory analysis 1h: Glucose control - Severe hypoglycemia [ Time Frame: 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

  9. Exploratory analysis 2a: Patient reported outcome - Adherence [ Time Frame: 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

  10. Exploratory analysis 2b: Patient reported outcome - Psychological distress [ Time Frame: 16-week period ]
    Within group change in the Diabetes Distress Scale from the beginning to the end of Phase 2.

  11. Exploratory analysis 2c: Patient reported outcome - Device satisfaction [ Time Frame: 16-week period ]
    Within group change in the Glucose Monitoring System Satisfaction Survey from the

  12. Exploratory analysis 2d: Patient reported outcome - Participant self-efficacy [ Time Frame: 16-week period ]
    Within group change in the Skills, Confidence and Preparedness Index (SCPI) from the beginning to the end of Phase 2.

  13. Exploratory analysis 3a: Effect of DSME goal achievement [ Time Frame: 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

  14. Exploratory analysis 3b: Effect of DSME goal achievement [ Time Frame: 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

  15. Exploratory analysis 3c: Effect of DSME goal achievement [ Time Frame: 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.

  16. Exploratory analysis 4: Frequency of glucose testing [ Time Frame: 16-week period ]
    The optimal frequency of glucose testing for greatest impact on glycemic control (TIR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562714


Contacts
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Contact: Natalie Gibbs 416-645-2928 ext 9316 natalie.gibbs@lmc.ca
Contact: Karri Venn 647-274-4133

Locations
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Canada, Ontario
LMC Brampton Not yet recruiting
Brampton, Ontario, Canada, L6S 0C6
Sub-Investigator: Harpreet Bajaj, MD         
LMC Etobicoke Not yet recruiting
Etobicoke, Ontario, Canada, M9R 4E1
Sub-Investigator: Hasnaian Khandwala, MD         
LMC Oakville Not yet recruiting
Oakville, Ontario, Canada, L6M 1M1
Sub-Investigator: Alexander Abitbol, MD         
LMC Ottawa Not yet recruiting
Ottawa, Ontario, Canada, K2J 0V2
Sub-Investigator: Nadia Malakieh, MD         
LMC Midtown Recruiting
Toronto, Ontario, Canada, M4G 3E8
Principal Investigator: Ronnie Aronson, MD         
LMC Vaughan/Thornhill Not yet recruiting
Vaughan, Ontario, Canada, L4K 4M2
Sub-Investigator: Ronald Goldenberg, MD         
Sponsors and Collaborators
LMC Diabetes & Endocrinology Ltd.
Abbott Diabetes Care
Investigators
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Principal Investigator: Ronnie Aronson, MD LMC Diabetes
Publications:
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Responsible Party: LMC Diabetes & Endocrinology Ltd.
ClinicalTrials.gov Identifier: NCT04562714    
Other Study ID Numbers: IMMEDIATE
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by LMC Diabetes & Endocrinology Ltd.:
Type 2 diabetes
Flash sensor glucose technology
Glucose monitoring
Randomized controlled trial
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases