Glucose Monitoring Comparison in Primary Care

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: CGM; Other: SMBG

• Registration Number: NCT05222815
• Lead Sponsor: HealthPartners Institute

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-03
• Study Start: 2022-08-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 359

Inclusion Criteria

1. Age 18 to 75 (inclusive)
2. Diagnosis of type 2 diabetes
3. A1C 7.5% to 12% (inclusive) in the last 2 months. (If A1C is older than 2 months at the baseline visit, a point-of-care or lab A1C may be done for eligibility)
4. Insulin use with or without other classes of glycemia medication use
5. No significant comorbidities that could impair the ability of a primary care team to manage diabetes, including but not limited to end stage renal disease, cognitive impairment, active cancer, and pregnancy
6. Established care within the HealthPartners Care Group, no plans to move within the next year, and willing to participate for the duration of the study
7. Willing and able to follow procedures for collecting blinded CGM data at baseline, 6 and 12 months follow-up
8. Willing to complete surveys at baseline, 3, 6, 9 and 12 months.
9. Willing to use SMBG or CGM, depending on randomization, in the way that their care team recommends and/or how they feel is most useful in managing their diabetes
10. Not currently using personal CGM
11. Not planning to become pregnant

Exclusion Criteria

1. Unwillingness or inability to provide informed consent
2. Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM (continuous glucose monitoring)	CGM	Use CGM, with availability of Ambulatory Glucose Profile (AGP) data, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.
SMBG (Self-monitoring of blood glucose)	SMBG	Use SMBG, as currently used in primary care, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.

Primary Outcome Measures

Name	Time	Method
Change in Diabetes Distress	12 months	To evaluate the effectiveness of two glucose monitoring strategies to reduce diabetes distress by measuring differential within-patient change by study arm in Diabetes Distress Scale scores from baseline to 12 months.
Change in A1C	12 months	To evaluate the effectiveness of two glucose monitoring strategies to reduce A1C levels by measuring differential within-patient change by study arm in A1C (%) from baseline to 12 months.

Trial Locations

Locations (1)

International Diabetes Center; 🇺🇸 Saint Louis Park, Minnesota, United States