SPARK-CGM Implementation
Purpose
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.
Condition
- Diabetes Mellitus
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This study uses type II hybrid effectiveness-implementation design combining (1) stepped-wedge cluster randomized trial (SW-CRT) evaluating effectiveness of SPARK-CGM and (2) post-intervention mixed methods implementation evaluation including interviews and surveys with patients, providers and clinic staff. Participating clinics will be randomized into four mutually exclusive cluster waves, stratified by clinic size, defined by the number of patients with insulin-treated diabetes, and by federally qualified health center status to ensure balance across waves. Clinics will sequentially transition from the usual care (control) condition to the intervention phase at three-month intervals until all clusters receive the intervention.
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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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. |
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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. |
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Recruiting Locations
The Bronx, New York 10467
More Details
- Status
- Recruiting
- Sponsor
- Montefiore Medical Center
Detailed Description
Continuous glucose monitoring (CGM) has been shown to reduce HbA1c levels, hypoglycemia, and improve quality of life, representing a powerful tool to improve population-level outcomes in diabetes. The American Diabetes Association (ADA) recommends CGM for all individuals with any type of diabetes on insulin, but its widespread adoption into primary care remains low. SPARK-CGM (Supporting Primary care Adoption, Resources, and Knowledge for CGM) is a hybrid effectiveness-implementation trial evaluating a multifaceted practice transformation package designed to increase new continuous glucose monitoring (CGM) prescriptions among adult patients with diabetes treated wtih insulin. This includes: (1) strengthening clinic capacity by streamlining CGM prescribing pathways; (2) optimizing pharmacy and insurance authorization workflows to reduce administrative burden; (3) providing prescriber-focused training on CGM workflows, data access, and interpretation to support effective clinical use; (4) training nursing and support staff to facilitate device initiation, patient education, and data management; and (5) delivering regular performance feedback on prescribing rates across clinics and providers. The effectiveness component will be evaluated using a stepped-wedge cluster randomized trial in which primary care clinic clusters sequentially transition from usual care to the SPARK-CGM implementation intervention over the study period until all clinics receive the intervention. The implementation component will include mixed-methods evaluation using surveys and semi-structured interviews with patients, providers and clinic staff to assess implementation outcomes. Based on pre-implementation clinic counts, the stepped-wedge trial will include 14 non-pilot primary care clinics. The investigators expect to include up to approximately 20,000 adult patients with insulin-treated diabetes who may contribute data to the effectiveness analysis (Aim 1) during the study period . For implementation evaluation and semi-structured interviews (Aim 2), investigators plan to recruit up to 40 adults with insulin-treated diabetes (10 per cluster) and 15-20 clinicians or clinic staff participants (4-5 per cluster) in order to reach thematic saturation.