SPARK-CGM Implementation

ConditionDiabetes Mellitus

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMontefiore Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All adult Montefiore primary care sites

Clinician and clinic staff will be eligible if they provide direct patient care or are involved in CGM prescribing, authorization, onboarding, or education at participating primary care clinics. Eligible clinicians include physicians, nurse practitioners, physician assistants, and clinicians in training. Eligible clinic staff may include nurses, medical assistants, and other relevant administrative staff

Age 18 years or older

Receive primary care at participating sites

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Enhanced CGM Interventions
Other intervention
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 intervention
Usual care

Treatment groups

20,000 Participants

are divided into 2 treatment groups

Group A: Implementation PhaseExperimental treatment 1 intervention

Group B: Pre-implementation phaseActive comparator 1 intervention

Trial outcomes

Primary outcomes

Time to first CGM prescription by primary care provider

Time to first CGM prescription initiated by a primary care provider (PCP) will be defined as the date from a patient's first eligible primary care encounter during the study period to the date of the first CGM prescription, up to 18 months following intervention initiation, as recorded in the electronic health record. All CGM orders are captured in the EHR. Results will be summarized by study arm using descriptive statistics and analyzed using Cox proportional hazards models.

Time frame