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

NCT04562714 | Completed FDA Device

• 1 other identifier: IMMEDIATE
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus, Type 2; Glucose

Keywords

Type 2 diabetes; Flash sensor glucose technology; Glucose monitoring; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• Glycemic control (a)

  2-week period

• Glycemic control (b)

  2-week period

• Glycemic control (c)

  2-week period

• Proportion of time spent in various glycemic ranges based on blinded CGM recordings

  2-week period

• Glycemic variability

  2-week period

Other Outcomes (16)

• Exploratory analysis 1a: Glucose control - Targeted glucose range

  16-week period

• Exploratory analysis 1b: Glucose control - hypoglycemia

  16-week period

• Exploratory analysis 1c: Glucose control - hyperglycemia

  16-week period

Study Arms (2)

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.

Device: FreeStyle Libre Flash Glucose Monitor; Other: Diabetes self-management education

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

Other: Diabetes self-management education

Interventions

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.

Intervention (FGM + DSME)

Diabetes self-management education OTHER

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); Intervention (FGM + DSME)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Abbott Diabetes Care: collaborator

Study Sites (6)

LMC Brampton

Brampton, Ontario, L6S 0C6, Canada

Location

LMC Etobicoke

Etobicoke, Ontario, M9R 4E1, Canada

Location

LMC Oakville

Oakville, Ontario, L6M 1M1, Canada

Location

LMC Ottawa

Ottawa, Ontario, K2J 0V2, Canada

Location

LMC Midtown

Toronto, Ontario, M4G 3E8, Canada

Location

LMC Vaughan/Thornhill

Vaughan, Ontario, L4K 4M2, Canada

Location

Related Publications (4)

• 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.

  PMID: 25923812 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.

  PMID: 24209600 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.

  PMID: 15735199 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.

  PMID: 31399439 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ronnie Aronson, MD

  LMC Diabetes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 24, 2020
• Study Start: September 8, 2020
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

CA (6)