NCT07548372

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
24mo left

Started May 2026

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2028

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Diabetes Mellitus

Keywords

ImplementationHbA1cMulti-component ImplementationContinuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 18 months following initiation of intervention

Secondary Outcomes (9)

  • CGM Utilization

    Up to 18 months following initiation of intervention

  • HbA1c

    Up to 18 months following initiation of intervention

  • Hospitalizations

    Up to 18 months following initiation of intervention

  • Emergency Department (ED) visits

    Up to 18 months following initiation of intervention

  • CGM prescription rate by race/ethnicity and payor

    Up to 18 months following initiation of intervention

  • +4 more secondary outcomes

Study Arms (2)

Implementation Phase

EXPERIMENTAL

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.

Other: Enhanced CGM Interventions

Pre-implementation phase

ACTIVE COMPARATOR

Patients in pre-implementation practices will receive the usual care under the direction of their primary care provider and practice.

Other: Standard of Care

Interventions

Enhanced CGM InterventionsOTHER

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.

Implementation Phase
Standard of CareOTHER

Usual care

Pre-implementation phase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinic level:
  • \- Sites participating in pilot phase of CGM initiative
  • Patient level:
  • \- Existing CGM prescription within 24 months before the study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Group (MMG)

The Bronx, New York, 10467, United States

Location

Related Publications (19)

  • Martens T, Beck RW, Bailey R, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021;325(22):2262-2272. doi:10.1001/jama.2021.7444

    BACKGROUND

  • Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW, et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008;359(14):1464-1476. doi:10.1056/NEJMoa0805017

    BACKGROUND

  • Beck RW, Riddlesworth T, Ruedy K, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017;317(4):371-378. doi:10.1001/jama.2016.19975

    BACKGROUND

  • Wada E, Onoue T, Kobayashi T, et al. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020;8(1):e001115. doi:10.1136/bmjdrc-2019-001115

    BACKGROUND

  • Heinemann L, Deiss D, Hermanns N, et al. HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections. J Diabetes Sci Technol. 2015;9(3):651-662. doi:10.1177/1932296815575999

    BACKGROUND

  • Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017;8(1):55-73. doi:10.1007/s13300-016-0223-6

    BACKGROUND

  • Johnston AR, Poll JB, Hays EM, Jones CW. Perceived impact of continuous glucose monitor use on quality of life and self-care for patients with type 2 diabetes. Diabetes Epidemiology and Management. 2022;6:100068. doi:10.1016/j.deman.2022.100068

    BACKGROUND

  • Polonsky WH, Hessler D. What Are the Quality of Life-Related Benefits and Losses Associated with Real-Time Continuous Glucose Monitoring? A Survey of Current Users. Diabetes Technology & Therapeutics. 2013;15(4):295-301. doi:10.1089/dia.2012.0298

    BACKGROUND

  • Polonsky WH, Hessler D, Ruedy KJ, Beck RW, for the DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017;40(6):736-741. doi:10.2337/dc17-0133

    BACKGROUND

  • ElSayed NA, Aleppo G, Aroda VR, et al. 7. Diabetes Technology: Standards of Care in Diabetes-2023. Diabetes Care. 2023;46(Suppl 1):S111-S127. doi:10.2337/dc23-S007

    BACKGROUND

  • Grunberger G, Sze D, Ermakova A, Sieradzan R, Oliveria T, Miller EM. Treatment Intensification With Insulin Pumps and Other Technologies in Patients With Type 2 Diabetes: Results of a Physician Survey in the United States. Clin Diabetes. 2020;38(1):47-55. doi:10.2337/cd19-0008

    BACKGROUND

  • Mayberry LS, Guy C, Hendrickson CD, McCoy AB, Elasy T. Rates and Correlates of Uptake of Continuous Glucose Monitors Among Adults with Type 2 Diabetes in Primary Care and Endocrinology Settings. J Gen Intern Med. 2023;38(11):2546-2552. doi:10.1007/s11606-023-08222-3

    BACKGROUND

  • Oser TK, Hall TL, Dickinson LM, et al. Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care. Ann Fam Med. 2022;20(6):541-547. doi:10.1370/afm.2876

    BACKGROUND

  • Davidson JA. The Increasing Role of Primary Care Physicians in Caring for Patients With Type 2 Diabetes Mellitus. Mayo Clinic Proceedings. 2010;85(12 Suppl):S3. doi:10.4065/mcp.2010.0466

    BACKGROUND

  • Pilla SJ, Segal JB, Maruthur NM. Primary Care Provides the Majority of Outpatient Care for Patients with Diabetes in the US: NAMCS 2009-2015. J Gen Intern Med. 2019;34(7):1089-1091. doi:10.1007/s11606-019-04843-9

    BACKGROUND

  • Vigersky RA, Fish L, Hogan P, et al. The clinical endocrinology workforce: current status and future projections of supply and demand. J Clin Endocrinol Metab. 2014;99(9):3112-3121. doi:10.1210/jc.2014-2257

    BACKGROUND

  • Ong KL, Stafford LK, McLaughlin SA, et al. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. The Lancet. 2023;402(10397):203-234. doi:10.1016/S0140-6736(23)01301-6

    BACKGROUND

  • Mathias P, Mahali LP, Agarwal S. Targeting Technology in Underserved Adults With Type 1 Diabetes: Effect of Diabetes Practice Transformations on Improving Equity in CGM Prescribing Behaviors. Diabetes Care. 2022;45(10):2231-2237. doi:10.2337/dc22-0555

    BACKGROUND

  • November 14-15, 2023, T1DX-QI Learning Session, Journal of Diabetes Abstracts. J Diabetes. 2023;15(Suppl 1):4-31. doi:10.1111/1753-0407.13488

    BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jovan Milosavljevic, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosina Antwi

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data sharing plan includes the following: In Specific Aim 1, valuable SPARK-CGM efficacy data may be of interest to other diabetes, health equity and primary care researchers. In Specific Aim 2, in-depth qualitative data of PCP and patients with diabetes may be of interest to investigators who want to apply similar interventions to new populations. Information on analytic methods will be shared with other collaborators, including providing statistical code and process logs that could be used to either confirm our results or apply similar statistical methods to related projects. Additional resources developed during this project, such as study protocols, educational materials for primary care providers, will be shared upon request or made available through appropriate channels

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
De-identified individual participant data will be deposited in an approved open data repository within six months of publication or within eighteen months of the conclusion of the funding period if the study remains unpublished.
Access Criteria
Data sharing will require: 1. Institutional Review Board approval, 2. Appropriate measures to ensure security of the data, 3. Commitment to destroying or returning the data after the analyses are completed.

Locations

US(1)