NCT07548372 · Montefiore Medical Center
SPARK-CGM Implementation
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Enhanced CGM Interventions
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.
OTHER
Standard of Care
Usual care
Primary outcome measures
Time to first CGM prescription by primary care provider
Time frame: Up to 18 months following initiation of intervention
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Clinic level:
- 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 Patient level:
- Age 18 years or older
- Receive primary care at participating sites
- Diagnosis of any diabetes mellitus
- Treated with insulin therapy
Exclusion criteria
- Clinic level: \- Sites participating in pilot phase of CGM initiative Patient level: \- Existing CGM prescription within 24 months before the study start
Where
- The Bronx, New York
Collaborators
American Diabetes Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations