isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes

Objective: To evaluate the effectiveness of intermittently scanned continuous glucose monitoring (isCGM) with education and feedback on glycemic control at 12 weeks, in adults with type 2 diabetes and uncontrolled HbA1c (> 7.0%) not on insulin therapy.

Background: Continuous glucose monitoring (CGM) has been shown to reduce hypoglycemia in adults on insulin. The effectiveness of CGM in adults with type 2 diabetes not on insulin therapy has not been well studied. We hypothesize that isCGM linked to structured education - specifically one-on-one review and feedback of glucose values with a diabetes educator - can improve HbA1c via a combination of improved lifestyle choices and accelerated medication intensification, in adults with earlier T2DM. To test this hypothesis, we propose a randomized controlled trial of isCGM + structured education, versus enhanced usual care with structured education only.

Methods: Open-label, 12-week, single-center randomized controlled trial. Included adults will be randomized 1:1 to intervention or enhanced usual care. Intervention participants will receive three FreeStyle Libre 2 (Abbott Laboratories, IL) isCGM sensors to be applied over weeks 1-6. Diabetes education and coaching will be provided at the beginning and end of the sensor period. The control group will receive diabetes education and coaching during weeks 1-2 and 5-6, but not the isCGM sensors. The primary outcome (HbA1c change from baseline) will be measured by venous blood draw at 12 weeks. Participants will be asked to complete patient-reported outcome instruments for secondary outcomes, e.g.: diabetes self-empowerment, diet, and physical activity - at baseline, 6 weeks, and 12 weeks.

Significance: This trial will examine the effectiveness of scheduled, intermittent use of isCGM sensors for type 2 diabetes, when combined with education and feedback. The intervention is designed to be affordable and applicable to a wide range of adults with diabetes, and may have significant implications for the use of isCGM.

Inclusion criteria

• Age >= 18 years with type 2 diabetes.
• HbA1c > 7.0% within the last 6 months.
• Non-insulin therapy.
• Able to attend two in-person study visits.
• English-speaking.
• Community-dwelling
• In possession of a cell phone capable of accessing the internet and receiving FreeStyle Libre 2 sensor readings
• Has a primary care provider who has been in contact with the patient for diabetes in the last 12 months.

Exclusion criteria

• Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.: MODY).
• Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 3 months.
• Pregnancy; plans to become pregnant within 6 months; breast-feeding.
• Any use of insulin in the previous year.
• Current or previous use of isCGM or rtCGM within the last 6 months.
• Cognitive dysfunction (SPMSQ score >= 5).
• Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and weight loss, accompanied by acute fatigue or dyspnea).
• Any terminal condition that would limit life expectancy to < 1 year.
• Inability to use isCGM (e.g.: afraid of the device).
• Inability to be reached by telephone.
• Concurrent participation in a different diabetes-related trial.
• Has not already received two doses of a Health Canada-approved vaccine against SARS-CoV-2.