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

Study Overview
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Brief Summary
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Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses a wearable sensor that continuously measures glucose levels under the skin. With intermittently scanned CGM (isCGM), patients scanning the sensor to obtain readings. isCGM is painless, provides information on glucose trends, and has improves patient satisfaction. Most adults with diabetes are not on insulin. Yet, the effectiveness of CGM is not well studied in this population. In this randomized trial, we are looking for adults with type 2 diabetes, who need further blood glucose lowering (HbA1c > 7.0%), who are not yet on insulin. Participants randomized to the treatment group (50%) will receive isCGM with individual coaching; those in the the enhanced usual care group (50%) will receive diabetes coaching only. The intervention will feature three FreeStyle Libre 2 (Abbott Laboratories, IL) sensors (6 weeks), and is intended to be affordable and applicable to a wide range of adults with diabetes under real world conditions.

Detailed Description
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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.

Official Title
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Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Intermittently scanned continuous glucose monitor (isCGM)
* Behavioral: Education and coaching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: isCGM with education and feedback<br>Intervention subjects will receive three isCGM sensors (FreeStyle Libre 2, Abbott Laboratories) for use over weeks 1-6. They will have encounters with a diabetes educator for individualized education and coaching during weeks 1-2 and 5-6. | Device: Intermittently scanned continuous glucose monitor (isCGM)<br>* A wearable sensor the size of 2 stacked quarters, that allows individuals to scan their glucose levels on demand. No fingerstick is required. The device measure interstitial glucose through a filament that is inserted under the skin. The application process is painless, and each sensor lasts 90 days. Sensors can be scanned with certain smart phones. This device is marketed as the FreeStyle Libre 2 glucometer (Abbott Laboratories, IL).<br>* Other names: Flash glucose monitor;Behavioral: Education and coaching<br>* Two encounters with a certified diabetes educator, who will assess lifestyle and medications, and provide individualized advice on diet, physical activity, and medication changes to improve glycemic control.<br>|
| Active Comparator: Enhanced usual care with education and feedback only<br>Enhanced usual care subjects will receive two encounters with a diabetes educator for individualized education and coaching, during weeks 1-2 and 5-6. They will not be provided with isCGM sensors. | Behavioral: Education and coaching<br>* Two encounters with a certified diabetes educator, who will assess lifestyle and medications, and provide individualized advice on diet, physical activity, and medication changes to improve glycemic control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change in HbA1c assessed by venous blood draw, compared to baseline. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes treatment satisfaction | Difference in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from baseline (DTSQs scores range 0-36, higher indicating better treatment satisfaction); DTSQc change score at 6 weeks. | 6 weeks and 12 weeks | 
| Diabetes self-care empowerment | Change in Diabetes Empowerment Scale - Short Form (DES-SF) score from baseline. DES-SF score ranges 1-5, higher scores indicating greater self-care empowerment. | 6 weeks and 12 weeks | 
| Diabetes-related distress | Change in Problem Areas in Diabetes Questionnaire (PAID) score from baseline. PAID score ranges 0-100, a score above 40 indicates severe diabetes distress. | 6 weeks and 12 weeks | 
| Healthy diet | Change in UK Diabetes and Diet Questionnaire (UKDDQ) score from baseline. UKDDQ score ranges 0-5 with higher scores indicating more healthy dietary choices. | 6 weeks and 12 weeks | 
| Physical activity | Change in International Physical Activity Questionnaire (IPAQ) short form score. IPAQ score estimates total metabolic equivalent-minutes per week, with higher scores indicating more a more physically active individual. | 6 weeks and 12 weeks | 
| Health-related quality of life | Change in Euroqol EQ-5D-5L health utility score from baseline. EQ-5D scores range from 0-100, with 100 indicating a state of perfect health. | 6 weeks and 12 weeks | 
| Emergency department visits | Number of emergency department visits during the 12-week trial period. | 12 weeks | 
| Hospital admissions | Number of hospital admissions during the 12-week trial period. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM, continuous glucose monitoring, flash glucose monitoring, intermittently scanned continuous glucose monitoring, non-insulin dependent diabetes