IMpact of Flash Glucose Monitoring in pEople With Type 2 Diabetes Inadequately Controlled With Non-insulin Antihyperglycemic ThErapy - IMMEDIATE Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- LMC Diabetes & Endocrinology Ltd.
- Enrollment
- 116
- Locations
- 6
- Primary Endpoint
- Time in Range (TIR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Mean DSME goal achievement score during Phase 1(16-week period)
- Device satisfaction as measured by the Glucose Monitoring System Satisfaction Survey (GMSS)(2-week period)
- Participant self-efficacy as measured by the Skills, Confidence and Preparedness Index (SCPI)(2-week period)
- Diabetes self-management education (DSME) goals setting(16-week period)
- Glycemic control (a)(2-week period)
- Glycemic control (c)(2-week period)
- Glycemic variability(2-week period)
- Number of episodes of severe hypoglycemia(16-week period)
- Adherence to diabetes medications as measured by the Adherence to Refills and Medication-Diabetes (ARMS-D)(2-week period)
- Change in weight (kg)(16-week period)
- Change in waist circumference (cm)(16-week period)
- Glycemic control (b)(2-week period)
- Proportion of time spent in various glycemic ranges based on blinded CGM recordings(2-week period)
- Number of documented episodes of hypoglycemia episodes(2-week period)
- Psychological distress as measured by the Diabetes Distress Scale (DDS)(2-week period)
- Change in antihyperglycemic therapies(2-week period)
- Mean number of glucose checks(2-week period)