Glucose Monitoring Comparison in Primary Care

NCT05222815 | Active Not Recruiting

• 1 other identifier: 19-326
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

CGM (continuous glucose monitoring)

EXPERIMENTAL

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.

Other: CGM

SMBG (Self-monitoring of blood glucose)

ACTIVE COMPARATOR

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.

Other: SMBG

Interventions

CGM OTHER

Continuous glucose monitor (CGM)-based glucose monitoring

CGM (continuous glucose monitoring)

SMBG OTHER

Self-monitoring of blood glucose (SMBG)-based glucose monitoring

SMBG (Self-monitoring of blood glucose)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• HealthPartners Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Richard M Bergenstal, MD

  International Diabetes Center, HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Thomas W Martens, MD

  International Diabetes Center, HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: August 29, 2022
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)