NCT05222815

Glucose Monitoring Comparison in Primary Care

Comparing Fingerstick Blood Glucose Monitoring Versus Continuous Glucose Monitoring in Primary Care

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research trial will randomize 50 primary care clinics and 354 patients in accordance with their primary care clinic assignment to 2 different glucose monitoring strategies (SMBG vs. CGM) and compare the effectiveness through a pragmatic clinic cluster randomized design, with active glycemic management in a "usual" primary care setting, over the course of a 12 month active study period.

Detailed description

The trial will evaluate the comparative effectiveness of SMBG (self-monitoring of blood glucose, also known as blood glucose monitoring \[BGM\] or fingerstick blood glucose monitoring) vs. continuous glucose monitoring (CGM), in managing glucose levels in individuals with type 2 diabetes (T2D) using insulin, with or without other glycemic therapies, in a primary care setting. The study will use a 2-arm, parallel group, cluster-randomized trial over a 12-month period. 50 primary care clinics will be randomly assigned to either use SMBG for glucose monitoring (25 clinics), with ongoing glycemic management provided by usual care in primary care, or CGM for glucose monitoring (25 clinics), with ongoing glycemic management provided by usual care in primary care using CGM and Ambulatory Glucose Profile (AGP) reports in a typical clinic setting. The study will use glycemic monitoring devices available to participants using real-world resources to cover the cost of the devices, and will be fundamentally pragmatic in nature. 354 patients (approximately 7/clinic) will be enrolled over 13 months (12 months of active intervention) with an intention-to-treat primary analysis.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	CGM	Continuous glucose monitor (CGM)-based glucose monitoring
OTHER	SMBG	Self-monitoring of blood glucose (SMBG)-based glucose monitoring

Timeline

• Start date: 2022-08-29
• Primary completion: 2025-10-01
• Completion: 2026-02-01
• First posted: 2022-02-03
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States