SPARK-CGM Implementation

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT07548372
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced CGM Interventions — OTHER
    The study intervention involves creating a streamlined workflow for CGM prescribing that does not restrict the treatment options available to patients or clinicians. SPARK-CGM implementation strategy includes three core practice transformations: (1) building clinic infrastructure by establishing CGM prescription workflows, and by training clinic staff to place CGM devices at the point of care, (2) provider training on accessing and using CGM data effectively in practice, and (3) regular feedback on prescription rates across the network.
  • Standard of Care — OTHER
    Usual care

Study Details

Continuous glucose monitoring (CGM) is a technology that helps individuals with diabetes track their sugar levels in real-time, leading to more in-range blood sugars, fewer episodes of dangerously low blood sugar, and improved quality of life. Despite these benefits, CGM is not widely used in primary care settings, where most people receive their diabetes care. The investigators aim to make CGM more accessible and equitably prescribed in primary care practices. The study team will support primary care to increase CGM use with a program called SPARK-CGM (Supporting Primary Care Adoption, Resources, and Knowledge for CGM) across a large network of primary care clinics at Montefiore Medical Center. This program will provide primary care providers (PCPs) with education, tools, and support to incorporate CGM into their routine care for people with diabetes. Investigators plan to test SPARK-CGM to evaluate whether it increases CGM prescriptions who are eligible to receive this technology.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
20,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Implementation Phase
    Clinics will sequentially transition from the usual care (control) condition to the intervention phase at three-month intervals until all clusters receive the intervention. The active implementation phase at each cluster will span six months, providing sufficient time to equip clinics to use CGM. The intervention includes development of clinic workflows for CGM prescribing and onboarding, provider education on CGM use and interpretation, training of clinic staff to support CGM initiation, and regular performance feedback on CGM prescribing rates.
  • Active Comparator: Pre-implementation phase
    Patients in pre-implementation practices will receive the usual care under the direction of their primary care provider and practice.

Primary Outcome Measure

Time to first CGM prescription by primary care provider [ Time Frame: Up to 18 months following initiation of intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical Group (MMG)The BronxNew York10467-

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Montefiore Medical Group (MMG)· The Bronx, NY

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