Recruiting

SPARK-CGM

Sponsor:

Montefiore Medical Center

Code:

NCT07548372

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced CGM Interventions

Standard of Care

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus

Study ID

NCT07548372

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

Standard of Care

Usual care

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rosina Antwi

646-515-8399rosina.antwi@einsteinmed.edu

Locations

Montefiore Medical Group (MMG)

Recruiting

The Bronx, New York, United States, 10467

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Implementation
  • HbA1c
  • Multi-component Implementation
  • Continuous glucose monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-06-23.