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

NCT ID: NCT05319496

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2024-03-12

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

isCGM with education and feedback

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.

Group Type: EXPERIMENTAL

Intermittently scanned continuous glucose monitor (isCGM)

Intervention Type: DEVICE

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).

Education and coaching

Intervention Type: BEHAVIORAL

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.

Enhanced usual care with education and feedback only

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.

Group Type: ACTIVE_COMPARATOR

Education and coaching

Intervention Type: BEHAVIORAL

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.

Interventions

Intermittently scanned continuous glucose monitor (isCGM)

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).

Intervention Type: DEVICE

Education and coaching

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Flash glucose monitor

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epidemiology Coordinating and Research Centre, Canada

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darren Lau, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital / Kaye Edmonton Clinic

Edmonton, Alberta, Canada

Countries

Canada

References

Olu-Jordan I, Singh P, Zheng JR, Yeung RO, Manca DP, Perry T, Rahim G, Hagen E, Lau D. The Effects of Continuous Glucose Monitoring on Patient-Reported Outcomes in Adults with Non-Insulin Dependent Type 2 Diabetes: A Randomized Controlled Trial. Can J Diabetes. 2025 Oct 27:S1499-2671(25)00354-5. doi: 10.1016/j.jcjd.2025.10.174. Online ahead of print.

Reference Type: DERIVED

PMID: 41161400 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Pro00119503

Identifier Type: -

Identifier Source: org_study_id