SPARK-CGM Implementation

NCT07548372 | Recruiting

• 2 other identifiers: 2025-169727-25-JDFPC-403
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

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

Keywords

Implementation; HbA1c; Multi-component Implementation; Continuous 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

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 Interventions OTHER

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 Care OTHER

Usual care

Pre-implementation phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• American Diabetes Association: collaborator

Study Sites (1)

Montefiore Medical Group (MMG)

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (19)

• Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.

  PMID: 34077499 BACKGROUND

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.

  PMID: 18779236 BACKGROUND

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 BACKGROUND

• Wada E, Onoue T, Kobayashi T, Handa T, Hayase A, Ito M, Furukawa M, Okuji T, Okada N, Iwama S, Sugiyama M, Tsunekawa T, Takagi H, Hagiwara D, Ito Y, Suga H, Banno R, Kuwatsuka Y, Ando M, Goto M, Arima H. 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 Jun;8(1):e001115. doi: 10.1136/bmjdrc-2019-001115.

  PMID: 32518063 BACKGROUND

• Heinemann L, Deiss D, Hermanns N, Graham C, Kaltheuner M, Liebl A, Price D. 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 May;9(3):651-62. doi: 10.1177/1932296815575999. Epub 2015 Mar 9.

  PMID: 25759183 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 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.

  PMID: 28000140 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 Technol Ther. 2013 Apr;15(4):295-301. doi: 10.1089/dia.2012.0298. Epub 2013 Feb 21.

  PMID: 23427866 BACKGROUND

• Polonsky WH, Hessler D, Ruedy KJ, Beck RW; 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 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.

  PMID: 28389582 BACKGROUND

• ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 7. Diabetes Technology: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S111-S127. doi: 10.2337/dc23-S007.

  PMID: 36507635 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 Jan;38(1):47-55. doi: 10.2337/cd19-0008.

  PMID: 31975751 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 Aug;38(11):2546-2552. doi: 10.1007/s11606-023-08222-3. Epub 2023 May 30.

  PMID: 37254011 BACKGROUND

• Oser TK, Hall TL, Dickinson LM, Callen E, Carroll JK, Nease DE Jr, Michaels L, Oser SM. Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care. Ann Fam Med. 2022 Nov-Dec;20(6):541-547. doi: 10.1370/afm.2876.

  PMID: 36443083 BACKGROUND

• Davidson JA. The increasing role of primary care physicians in caring for patients with type 2 diabetes mellitus. Mayo Clin Proc. 2010 Dec;85(12 Suppl):S3-4. doi: 10.4065/mcp.2010.0466. Epub 2010 Nov 24. No abstract available.

  PMID: 21106869 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 Jul;34(7):1089-1091. doi: 10.1007/s11606-019-04843-9. No abstract available.

  PMID: 30719646 BACKGROUND

• Vigersky RA, Fish L, Hogan P, Stewart A, Kutler S, Ladenson PW, McDermott M, Hupart KH. The clinical endocrinology workforce: current status and future projections of supply and demand. J Clin Endocrinol Metab. 2014 Sep;99(9):3112-21. doi: 10.1210/jc.2014-2257. Epub 2014 Jun 18.

  PMID: 24940655 BACKGROUND

• GBD 2021 Diabetes Collaborators. 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. Lancet. 2023 Jul 15;402(10397):203-234. doi: 10.1016/S0140-6736(23)01301-6. Epub 2023 Jun 22.

  PMID: 37356446 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 Oct 1;45(10):2231-2237. doi: 10.2337/dc22-0555.

  PMID: 36054022 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

• U.S. Census Bureau QuickFacts: Bronx County, New York.
• Behavioral Risk Factor Surveillance System (BRFSS) Health Indicators by County and Region \| State of New York.
• Glucose\_Monitoring\_Criteria\_-\_10-2-23.pdf.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jovan Milosavljevic, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosina Antwi

CONTACT

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

Study Design

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

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.

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: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• 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)