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

NCT05319496 | Completed

• 1 other identifier: Pro00119503
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

continuous glucose monitoring; flash glucose monitoring; intermittently scanned continuous glucose monitoring; CGM; non-insulin dependent diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c assessed by venous blood draw, compared to baseline.

  12 weeks

Secondary Outcomes (8)

• Diabetes treatment satisfaction

  6 weeks and 12 weeks

• Diabetes self-care empowerment

  6 weeks and 12 weeks

• Diabetes-related distress

  6 weeks and 12 weeks

• Healthy diet

  6 weeks and 12 weeks

• Physical activity

  6 weeks and 12 weeks

Study Arms (2)

isCGM with education and feedback

EXPERIMENTAL

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); Behavioral: Education and coaching

Enhanced usual care with education and feedback only

ACTIVE COMPARATOR

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

Interventions

Intermittently scanned continuous glucose monitor (isCGM) 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).

Also known as: Flash glucose monitor

isCGM with education and feedback

Education and coaching 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; isCGM with education and feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Epidemiology Coordinating and Research Centre, Canada: collaborator

Study Sites (1)

University of Alberta Hospital / Kaye Edmonton Clinic

Edmonton, Alberta, T6G 1Z1, Canada

Location

Related Publications (1)

• Olu-Jordan I, Singh P, Zhang 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.

  PMID: 41161400 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Darren Lau, MD/PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: October 5, 2022
• Primary Completion: January 15, 2024
• Study Completion: March 12, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)