Clinical trial NCT05319496: isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes
Official title: Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: continuous glucose monitoring
flash glucose monitoring
intermittently scanned continuous glucose monitoring
CGM
non-insulin dependent diabetes
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Epidemiology Coordinating and Research Centre, Canada
First posted: 2022-04-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Diabetes treatment satisfaction
timeFrame: 6 weeks and 12 weeks
measure: Diabetes self-care empowerment
timeFrame: 6 weeks and 12 weeks
measure: Diabetes-related distress
timeFrame: 6 weeks and 12 weeks
measure: Healthy diet
timeFrame: 6 weeks and 12 weeks
measure: Physical activity
timeFrame: 6 weeks and 12 weeks
measure: Health-related quality of life
timeFrame: 6 weeks and 12 weeks
measure: Emergency department visits
timeFrame: 12 weeks
measure: Hospital admissions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital / Kaye Edmonton Clinic
state: Alberta
Study officials:
affiliation: University of Alberta
name: Darren Lau, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: