Clinical trial NCT05222815: Glucose Monitoring Comparison in Primary Care
Official title: Comparing Fingerstick Blood Glucose Monitoring Versus Continuous Glucose Monitoring in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Continuous Glucose Monitor
Blood Glucose Monitor
Self-Monitoring of Blood Glucose
Primary Care
Glycemic Control
Time In Range
Diabetes Distress
Insulin
A1C
Glucose Management
Comparative effectiveness
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-02-03
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in A1C
timeFrame: 12 months
measure: Change in Diabetes Distress
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis Park
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center, HealthPartners Institute
name: Richard M Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center, HealthPartners Institute
name: Thomas W Martens, MD
role: PRINCIPAL_INVESTIGATOR
References: