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

NCT05319496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-02-06

No results posted yet for this study

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

Interventions

DEVICE

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).

BEHAVIORAL

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.

Sponsors & Collaborators

  • Epidemiology Coordinating and Research Centre, Canada

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Darren Lau, MD/PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2024-01-15
Completion
2024-03-12

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319496 on ClinicalTrials.gov