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

Diabetes Mellitus, Type 2 Clinical Trial

— IMMEDIATE  

Official title:

IMpact of Flash Glucose Monitoring in pEople With Type 2 Diabetes Inadequately Controlled With Non-insulin Antihyperglycemic ThErapy - IMMEDIATE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562714
• Other study ID #: IMMEDIATE
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: September 6, 2022

Study information

• Verified date: November 2023
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose

Intervention

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: 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) Education modules for both in-person and remote delivery; Handouts to support the curriculum objectives; and Blood glucose monitoring challenges to stimulate behaviour change and reinforce learning.

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.	Abbott Diabetes Care

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Exploratory analysis 1b: Glucose control - hypoglycemia	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Exploratory analysis 2c: Patient reported outcome - Device satisfaction	Within group change in the Glucose Monitoring System Satisfaction Survey from the	16-week period
Other	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
Other	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
Other	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
Other	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
Other	Exploratory analysis 4: Frequency of glucose testing	The optimal frequency of glucose testing for greatest impact on glycemic control (TIR)	16-week period
Primary	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	Glycemic control (a)	Mean HbA1c (blood drawn for laboratory testing) at the end of Phase 1	2-week period
Secondary	Glycemic control (b)	Proportion of participants with HbA1c < 7.0% and with HbA1c > 9.0% at the end of Phase 1	2-week period
Secondary	Glycemic control (c)	Mean glucose based on blinded CGM recordings at the end of Phase 1	2-week period
Secondary	Proportion of time spent in various glycemic ranges based on blinded CGM recordings	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)	2-week period
Secondary	Glycemic variability	Standard deviation and % coefficient of variation based on blinded CGM recordings	2-week period
Secondary	Number of documented episodes of hypoglycemia episodes	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)	2-week period
Secondary	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
Secondary	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 (a=0.86), shows good convergent validity with other adherence to medication scales, and independently predicts HbA1c (ß=0.16, p<0.01)	2-week period
Secondary	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 (a > 0.87) and validity.	2-week period
Secondary	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
Secondary	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
Secondary	Change in antihyperglycemic therapies	Change in the mean number of antihyperglycemic therapies from baseline to end of	2-week period
Secondary	Change in weight (kg)	Change in weight (kg) from baseline to end of Phase 1	16-week period
Secondary	Change in waist circumference (cm)	Change in waist circumference (cm) from baseline to end of Phase 1	16-week period
Secondary	Diabetes self-management education (DSME) goals setting	Mean number of diabetes self-management education (DSME) goals set per person	16-week period
Secondary	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
Secondary	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