T1DTechCHW: Enhancing the Community Health Worker Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups

NCT05211869 | Completed DMC

• 2 other identifiers: 2021-13714R01DK132302
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1D-CATCH) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (YA-URMs) with type 1 diabetes (T1D). The investigators will conduct a 9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care. The investigators will recruit from adult and pediatric endocrinology and primary care practices in a large safety-net health system in the Bronx, New York. Our specific aims are to 1) evaluate T1D-CATCH effects on technology initiation and continued use over 6 months and 2) evaluate T1D-CATCH implementation using Proctor's Taxonomy of Implementation Outcomes: feasibility, adoption, fidelity, and cost.

Conditions

Diabetes; Type 1 Diabetes; Young Adult; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Technology Initiation

  Technology use will be tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured and reported as a binary variable (yes/no). Technology will include any combination of continuous glucose monitor (CGM), pump, or CGM and pump. Technology initiation will be defined as at least 1 week of first use in the 6-month period. Variables will be described using summary statistics with counts/percentages.

  6 months following intervention

Secondary Outcomes (3)

• Technology Initiation

  3 months following intervention

• Continued Technology Use - Percent Use

  9 months following intervention

• Continued Technology Use - Days of wear

  9 months following intervention

Other Outcomes (42)

• Feasibility Check

  6 months (post-intervention)

• Adoption

  9 months (post-intervention)

• Adoption

  9 months (post-intervention)

Study Arms (2)

T1D-CATCH

EXPERIMENTAL

The CHW intervention will consist of both individual and optional group sessions with YA-URMs with T1D. In individual sessions, CHWs will provide T1D technology education, peer support, and social needs management. Over the 9-month study period, session frequency will involve weekly individual sessions based on participant technology milestones and an optional monthly CHW-led peer group support session. CHW individual and group sessions will be held via videoconferencing or in person, per participant preference and institutional COVID-19 rules.

Behavioral: T1D-CATCH

Usual Care Control Condition

NO INTERVENTION

Control arm participants will receive usual primary or endocrine care at Montefiore. Usual care consists of a physician or nurse practitioner visit with review of blood sugars and treatment decisions based on provider experience. Physicians in endocrinology practices are nested within a diabetes center with access to diabetes nurse practitioners/educators, dieticians, a psychologist, and nurses. In all practices, patients are recommended to see their physician or nurse practitioner every 3 months and attend individual or group sessions.

Interventions

T1D-CATCH BEHAVIORAL

As defined by the Centers for Disease Control and Prevention (CDC), a CHW is "a frontline public health worker who is a trusted member of a community or who has a thorough understanding of the community being served, and leverages this unique position to link health systems, social services, and communities". CHWs engender trust with patients by having direct community and lived experience, offering specific support and empathy that may be difficult for other diabetes care professionals to provide. In addition, CHWs have firsthand understanding of cultural barriers to traditional western healthcare and can promote patient-centered culturally-relevant care. They enhance team-based care by helping providers with extra outreach, social needs management, time-consuming tasks, and aligning patient-provider priorities. CHWs in this project will provide social needs assessment and management, introduction to diabetes technologies, and support for onboarding to technology.

T1D-CATCH

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• T1D duration ≥6 months
• years old
• Self-identified URM status: non-Hispanic Black or Hispanic
• English- or Spanish-speaking
• Not currently on a connected diabetes technology system (includes never offered, prescribed but not started within 3 months of receiving the device, discontinued, or previously refused technology)

You may not qualify if:

• Developmental or sensory disability interfering with study participation
• Current pregnancy
• Participation in another behavioral or diabetes technology intervention study in the past 6 months.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (24)

• Agarwal S, Schechter C, Gonzalez J, Long JA. Racial-Ethnic Disparities in Diabetes Technology use Among Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Apr;23(4):306-313. doi: 10.1089/dia.2020.0338. Epub 2020 Dec 1.

  PMID: 33155826 BACKGROUND

• Willi SM, Miller KM, DiMeglio LA, Klingensmith GJ, Simmons JH, Tamborlane WV, Nadeau KJ, Kittelsrud JM, Huckfeldt P, Beck RW, Lipman TH; T1D Exchange Clinic Network. Racial-ethnic disparities in management and outcomes among children with type 1 diabetes. Pediatrics. 2015 Mar;135(3):424-34. doi: 10.1542/peds.2014-1774.

  PMID: 25687140 BACKGROUND

• Livingstone SJ, Levin D, Looker HC, Lindsay RS, Wild SH, Joss N, Leese G, Leslie P, McCrimmon RJ, Metcalfe W, McKnight JA, Morris AD, Pearson DW, Petrie JR, Philip S, Sattar NA, Traynor JP, Colhoun HM; Scottish Diabetes Research Network epidemiology group; Scottish Renal Registry. Estimated life expectancy in a Scottish cohort with type 1 diabetes, 2008-2010. JAMA. 2015 Jan 6;313(1):37-44. doi: 10.1001/jama.2014.16425.

  PMID: 25562264 BACKGROUND

• Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18.

  PMID: 30657336 BACKGROUND

• McKergow E, Parkin L, Barson DJ, Sharples KJ, Wheeler BJ. Demographic and regional disparities in insulin pump utilization in a setting of universal funding: a New Zealand nationwide study. Acta Diabetol. 2017 Jan;54(1):63-71. doi: 10.1007/s00592-016-0912-7. Epub 2016 Sep 20.

  PMID: 27650535 BACKGROUND

• Agarwal S, Crespo-Ramos G, Long JA, Miller VA. "I Didn't Really Have a Choice": Qualitative Analysis of Racial-Ethnic Disparities in Diabetes Technology Use Among Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Sep;23(9):616-622. doi: 10.1089/dia.2021.0075.

  PMID: 33761284 BACKGROUND

• Lai CW, Lipman TH, Willi SM, Hawkes CP. Racial and Ethnic Disparities in Rates of Continuous Glucose Monitor Initiation and Continued Use in Children With Type 1 Diabetes. Diabetes Care. 2021 Jan;44(1):255-257. doi: 10.2337/dc20-1663. Epub 2020 Nov 11.

  PMID: 33177169 BACKGROUND

• Addala A, Auzanneau M, Miller K, Maier W, Foster N, Kapellen T, Walker A, Rosenbauer J, Maahs DM, Holl RW. A Decade of Disparities in Diabetes Technology Use and HbA1c in Pediatric Type 1 Diabetes: A Transatlantic Comparison. Diabetes Care. 2021 Jan;44(1):133-140. doi: 10.2337/dc20-0257. Epub 2020 Sep 16.

  PMID: 32938745 BACKGROUND

• Addala A, Hanes S, Naranjo D, Maahs DM, Hood KK. Provider Implicit Bias Impacts Pediatric Type 1 Diabetes Technology Recommendations in the United States: Findings from The Gatekeeper Study. J Diabetes Sci Technol. 2021 Sep;15(5):1027-1033. doi: 10.1177/19322968211006476. Epub 2021 Apr 15.

  PMID: 33858206 BACKGROUND

• Walker AF, Hood KK, Gurka MJ, Filipp SL, Anez-Zabala C, Cuttriss N, Haller MJ, Roque X, Naranjo D, Aulisio G, Addala A, Konopack J, Westen S, Yabut K, Mercado E, Look S, Fitzgerald B, Maizel J, Maahs DM. Barriers to Technology Use and Endocrinology Care for Underserved Communities With Type 1 Diabetes. Diabetes Care. 2021 Jul;44(7):1480-1490. doi: 10.2337/dc20-2753. Epub 2021 May 17.

  PMID: 34001535 BACKGROUND

• Findley SE, Matos S, Hicks AL, Campbell A, Moore A, Diaz D. Building a consensus on community health workers' scope of practice: lessons from New York. Am J Public Health. 2012 Oct;102(10):1981-7. doi: 10.2105/AJPH.2011.300566. Epub 2012 Aug 16.

  PMID: 22897548 BACKGROUND

• Saydah S, Imperatore G, Cheng Y, Geiss LS, Albright A. Disparities in Diabetes Deaths Among Children and Adolescents - United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2017 May 19;66(19):502-505. doi: 10.15585/mmwr.mm6619a4.

  PMID: 28520705 BACKGROUND

• Walker RJ, Gebregziabher M, Martin-Harris B, Egede LE. Independent effects of socioeconomic and psychological social determinants of health on self-care and outcomes in Type 2 diabetes. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):662-8. doi: 10.1016/j.genhosppsych.2014.06.011. Epub 2014 Jul 9.

  PMID: 25103544 BACKGROUND

• Walker RJ, Gebregziabher M, Martin-Harris B, Egede LE. Quantifying direct effects of social determinants of health on glycemic control in adults with type 2 diabetes. Diabetes Technol Ther. 2015 Feb;17(2):80-7. doi: 10.1089/dia.2014.0166. Epub 2014 Oct 31.

  PMID: 25361382 BACKGROUND

• Berkowitz SA, Meigs JB, DeWalt D, Seligman HK, Barnard LS, Bright OJ, Schow M, Atlas SJ, Wexler DJ. Material need insecurities, control of diabetes mellitus, and use of health care resources: results of the Measuring Economic Insecurity in Diabetes study. JAMA Intern Med. 2015 Feb;175(2):257-65. doi: 10.1001/jamainternmed.2014.6888.

  PMID: 25545780 BACKGROUND

• Berkowitz SA, Kalkhoran S, Edwards ST, Essien UR, Baggett TP. Unstable Housing and Diabetes-Related Emergency Department Visits and Hospitalization: A Nationally Representative Study of Safety-Net Clinic Patients. Diabetes Care. 2018 May;41(5):933-939. doi: 10.2337/dc17-1812. Epub 2018 Jan 4.

  PMID: 29301822 BACKGROUND

• Hall WJ, Chapman MV, Lee KM, Merino YM, Thomas TW, Payne BK, Eng E, Day SH, Coyne-Beasley T. Implicit Racial/Ethnic Bias Among Health Care Professionals and Its Influence on Health Care Outcomes: A Systematic Review. Am J Public Health. 2015 Dec;105(12):e60-76. doi: 10.2105/AJPH.2015.302903. Epub 2015 Oct 15.

  PMID: 26469668 BACKGROUND

• Hagiwara N, Elston Lafata J, Mezuk B, Vrana SR, Fetters MD. Detecting implicit racial bias in provider communication behaviors to reduce disparities in healthcare: Challenges, solutions, and future directions for provider communication training. Patient Educ Couns. 2019 Sep;102(9):1738-1743. doi: 10.1016/j.pec.2019.04.023. Epub 2019 Apr 19.

  PMID: 31036330 BACKGROUND

• Franklin CM, Bernhardt JM, Lopez RP, Long-Middleton ER, Davis S. Interprofessional Teamwork and Collaboration Between Community Health Workers and Healthcare Teams: An Integrative Review. Health Serv Res Manag Epidemiol. 2015 Mar 16;2:2333392815573312. doi: 10.1177/2333392815573312. eCollection 2015 Jan-Dec.

  PMID: 28462254 BACKGROUND

• Schaaf M, Warthin C, Freedman L, Topp SM. The community health worker as service extender, cultural broker and social change agent: a critical interpretive synthesis of roles, intent and accountability. BMJ Glob Health. 2020 Jun;5(6):e002296. doi: 10.1136/bmjgh-2020-002296.

  PMID: 32546585 BACKGROUND

• C3 Project. The Community Health Worker Core Consensus Project (C3): Roles and Competencies. C3 Project Findings. Published 2018. Accessed April 29, 2021. https://www.c3project.org/roles-competencies

  BACKGROUND

• Palmas W, March D, Darakjy S, Findley SE, Teresi J, Carrasquillo O, Luchsinger JA. Community Health Worker Interventions to Improve Glycemic Control in People with Diabetes: A Systematic Review and Meta-Analysis. J Gen Intern Med. 2015 Jul;30(7):1004-12. doi: 10.1007/s11606-015-3247-0. Epub 2015 Mar 4.

  PMID: 25735938 BACKGROUND

• Ballard M, Westgate C, Alban R, Choudhury N, Adamjee R, Schwarz R, Bishop J, McLaughlin M, Flood D, Finnegan K, Rogers A, Olsen H, Johnson A, Palazuelos D, Schechter J. Compensation models for community health workers: Comparison of legal frameworks across five countries. J Glob Health. 2021 Feb 15;11:04010. doi: 10.7189/jogh.11.04010.

  PMID: 33692894 BACKGROUND

• Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27.

  PMID: 29703724 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Shivani Agarwal, MD, MPH

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized after enrollment into the study using REDCap. Study staff will notify CHWs of participant assignment to the intervention arm based on REDCap. Investigators, except the PI, and outcome assessors will remain blinded to arm assignment. The PI will not be able to be blinded because they will be required to do supervision and close oversight of the CHWs.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 27, 2022
• Study Start: November 7, 2022
• Primary Completion: September 8, 2025
• Study Completion: December 8, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)