Glucose Monitoring Comparison in Primary Care

Diabetes Mellitus, Type 2 Clinical Trial

— GluCoCare  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05222815
• Other study ID #: 19-326
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: June 2024
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 359
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• CGM
Continuous glucose monitor (CGM)-based glucose monitoring
• SMBG
Self-monitoring of blood glucose (SMBG)-based glucose monitoring

Locations

Country	Name	City	State
United States	International Diabetes Center	Saint Louis Park	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1C	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.	12 months
Primary	Change in Diabetes Distress	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.	12 months