Glucose Monitoring Comparison in Primary Care
Running, not enrolling · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT05222815
- Run by
- HealthPartners Institute
- People needed
- 360
- Starts
- 2022-08-29
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- International Diabetes Center — Saint Louis Park, Minnesota, United States
Full record on ClinicalTrials.gov
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