SPARK-CGM Implementation

Официальное название

Supporting Primary Care Adoption, Resources, and Knowledge for Continuous Glucose Monitoring

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое Standard of Care
  Usual care

Первичные конечные точки

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

Вторичные конечные точки (9)

• CGM Utilization [Срок оценки: Up to 18 months following initiation of intervention]
• HbA1c [Срок оценки: Up to 18 months following initiation of intervention]
• Hospitalizations [Срок оценки: Up to 18 months following initiation of intervention]
• Emergency Department (ED) visits [Срок оценки: Up to 18 months following initiation of intervention]
• CGM prescription rate by race/ethnicity and payor [Срок оценки: Up to 18 months following initiation of intervention]
• Longitudinal glucose time in range (TIR) [Срок оценки: Up to 18 months following initiation of intervention]
• Longitudinal glucose time below range (TBR) [Срок оценки: Up to 18 months following initiation of intervention]
• Longitudinal glucose time above range (TAR) [Срок оценки: Up to 18 months following initiation of intervention]
• Longitudinal glucose management indicator (GMI) [Срок оценки: Up to 18 months following initiation of intervention]

Критерии участия

Критерии включения

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

Критерии исключения

Clinic level:

\- Sites participating in pilot phase of CGM initiative

Patient level:

\- Existing CGM prescription within 24 months before the study start

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Montefiore Medical Group (MMG) — The Bronx

Публикации

• 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 PMID 34077499
• 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 PMID 18779236
• 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
• 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 Di PMID 32518063
• 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/ PMID 25759183
• 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
• 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
• 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

Идентификаторы

NCT: NCT07548372 · 2025-16972 · 7-25-JDFPC-403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗