Status:
ACTIVE_NOT_RECRUITING
Glucose Monitoring Comparison in Primary Care
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
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 comp...
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 ...
Eligibility Criteria
Inclusion
- Age 18 to 75 (inclusive)
- Diagnosis of type 2 diabetes
- 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)
- Insulin use with or without other classes of glycemia medication use
- 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
- 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
- Willing and able to follow procedures for collecting blinded CGM data at baseline, 6 and 12 months follow-up
- Willing to complete surveys at baseline, 3, 6, 9 and 12 months.
- 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
- Not currently using personal CGM
- Not planning to become pregnant
Exclusion
- Unwillingness or inability to provide informed consent
- Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)
Key Trial Info
Start Date :
August 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05222815
Start Date
August 29 2022
End Date
February 1 2026
Last Update
January 5 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
International Diabetes Center
Saint Louis Park, Minnesota, United States, 55416