Increasing CGM Use Among Patients With T2D

NCT06638099 | Recruiting

• 2 other identifiers: HS-2024-0026UH3MD018353
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 2

Brief Summary

Study Overview: This interventional study aims to assess whether training healthcare professionals (HCPs) increases the number of continuous glucose monitor (CGM) prescriptions for patients with Type 2 Diabetes in a Federally Qualified Health Center serving a predominantly Hispanic/Latino population. Research Questions: Does HCP training enhance CGM prescription rates in a primary care setting? Does receiving a CGM prescription lead to improved Type 2 Diabetes control, as measured by Hemoglobin A1c levels? What barriers do patients face when prescribed and using CGMs? Given the significant impact of CGMs on diabetes management, this project seeks to improve CGM utilization among eligible patients through a focused intervention for HCPs and evaluate diabetes outcomes for those who do and do not receive a CGM. Methodology: HCPs and staff from three clinics within the same healthcare system will undergo a brief, in-person training on current clinical guidelines and insurance eligibility for CGMs. A booster session will follow about one month later to reinforce learning and address any prescribing challenges. Training efficacy will be evaluated by comparing CGM prescription rates before and after training using electronic health records. HCPs will complete pre- and post-training surveys to assess changes in knowledge, beliefs, and prescribing practices related to CGMs. Additionally, a small subset of prescribers will participate in interviews about their experiences with CGM prescriptions four months post-training. Patient Recruitment and Surveys: Patients with Type 2 Diabetes will be recruited for surveys at baseline, and at 3 and 6 months. These surveys will gather information on their diabetes management experience, levels of diabetes distress, and whether CGM discussions occurred with their primary care provider. Participants who received CGM prescriptions will share their experiences and any barriers encountered. A subset will also be invited for interviews to further explore their CGM experiences. Conclusion: This study seeks to fill a crucial gap in understanding how HCP training influences CGM prescription rates and the associated diabetes management outcomes, ultimately aiming to enhance diabetes care for a vulnerable population.

Conditions

Diabetes; Diabetes Mellitus; Diabetes Mellitus Type 2; Diabetes Mellitus Type 2 (T2DM)

Keywords

Diabetes Mellitus Type 2; Continuous Glucose Monitor; FQHC Intervention; health care providers; CGM Education

Outcome Measures

Primary Outcomes (1)

• CGM prescription rates

  Determine if the proportion of patients with T2D who are prescribed CGM increases following the intervention as compared to pre-intervention data

  From training until month 6

Secondary Outcomes (4)

• HCP/Staff Knowledge and Attitudes Towards CGM Use & Prescribing Behavior in Target Population

  Pre-training to Month 3

• Effect of CGM Prescription on HgbA1C

  Receipt of CGM Prescription to Month 6

• Effect of CGM on Individual Diabetes Distress Among Patients with T2D

  Receipt of CGM Prescription to month 6

• Challenges and Facilitators to CGM Uptake in Patients with T2D

  Receipt of CGM to Month 6

Other Outcomes (2)

• Participant Experience with Prescribing, Acquiring and/or Using a CGM.

  Clinic Implementation to Month 9

• HCP/Staff Experiences with Prescribing & Monitoring CGM use in Target Population

  Toolkit Training to Month 6

Study Arms (2)

Healthcare Prescribers Exposed to CGM Prescriber Toolkit Training

EXPERIMENTAL

Participants in this arm will include qualified healthcare prescribers (MDs, DOs, PAs, NPs, etc.) and staff who treat patients with Type 2 diabetes in primary care settings who will receive in depth training using a study-developed prescriber toolkit. The toolkit covers important information including current clinical practice guidelines, eligibility criteria, provider documentation requirements and scripts for discussing CGM use with their patient population. The impact of the training will be evaluated by examining changes in CGM prescription rates for patients with Type 2 diabetes seen in primary care before and after the training is delivered. Secondarily, Participants will be surveyed pre- and post-training to elicit prescribing knowledge and attitudes towards CGM use.

Behavioral: CGM Toolkit Prescriber Training

Healthcare Prescribers Not Exposed to CGM Prescriber Toolkit Training

NO INTERVENTION

Participants in this arm are prescribers (MDs, DOs, PAs, NPs, etc.) and staff who will NOT receive in depth training using a study-developed prescriber toolkit.

Interventions

CGM Toolkit Prescriber Training BEHAVIORAL

A CGM prescription toolkit was created for prescribing clinicians and staff that includes written guidance on CGM eligibility criteria, instructions for screening patients for eligibility using EHR records and during healthcare visits, recommended provider documentation templates to address all required eligibility criteria for insurance coverage of CGM device and supplies (e.g., Medicare, Medicaid), sample scripts for communicating with patients about the purpose and use of CGM, and patient-level frequently asked questions (FAQs), including free resources available to learn more about CGM benefits, where/how to acquire CGM, and determining out-of-pocket costs. The toolkit will be introduced during a 20 minute initial training session and reinforced during a 10 minute booster training approximately one month after initial training

Healthcare Prescribers Exposed to CGM Prescriber Toolkit Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults 18 years or older,
• have been diagnosed with T2D at least one year prior to recruitment,
• are a current patient of one of the three participating Innercare Clinics with no -
• plans to discontinue their care at Innercare within the next 6 months,
• can understand and speak in English or Spanish,
• have telephone access,
• do not plan to move out of the area within the next 6 months.

You may not qualify if:

• Plans to move out of the area in the next 6 months
• Patients with newly diagnose diabetes mellitus (less than one year), diabetes insipidus, diabetes type 1 or gestational diabetes.
• Provider/Staff Eligibility:
• years or older,
• able to read and write in English,
• currently employed at one of the participating Innercare clinics (Brawley, El Centro, Calexico),
• Personnel without experience providing care to adult patients with T2D in primary care settings.

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of California, Berkeley: collaborator

Study Sites (2)

Innercare Inc

El Centro, California, 92243, United States

RECRUITING

Innercare, Inc

El Centro, California, 92243, United States

RECRUITING

Related Publications (23)

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• Lanning MS, Tanenbaum ML, Wong JJ, Hood KK. Barriers to Continuous Glucose Monitoring in People With Type 1 Diabetes: Clinician Perspectives. Diabetes Spectr. 2020 Nov;33(4):324-330. doi: 10.2337/ds19-0039.

  PMID: 33223770 BACKGROUND

• Tanenbaum ML, Hanes SJ, Miller KM, Naranjo D, Bensen R, Hood KK. Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets. Diabetes Care. 2017 Feb;40(2):181-187. doi: 10.2337/dc16-1536. Epub 2016 Nov 29.

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• Smith MB, Albanese-O'Neill A, Macieira TGR, Yao Y, Abbatematteo JM, Lyon D, Wilkie DJ, Haller MJ, Keenan GM. Human Factors Associated with Continuous Glucose Monitor Use in Patients with Diabetes: A Systematic Review. Diabetes Technol Ther. 2019 Oct;21(10):589-601. doi: 10.1089/dia.2019.0136. Epub 2019 Aug 20.

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  PMID: 36857171 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

• Kanbour S, Jones M, Abusamaan MS, Nass C, Everett E, Wolf RM, Sidhaye A, Mathioudakis N. Racial Disparities in Access and Use of Diabetes Technology Among Adult Patients With Type 1 Diabetes in a U.S. Academic Medical Center. Diabetes Care. 2023 Jan 1;46(1):56-64. doi: 10.2337/dc22-1055.

  PMID: 36378855 BACKGROUND

• Isaacs D, Bellini NJ, Biba U, Cai A, Close KL. Health Care Disparities in Use of Continuous Glucose Monitoring. Diabetes Technol Ther. 2021 Sep;23(S3):S81-S87. doi: 10.1089/dia.2021.0268.

  PMID: 34546086 BACKGROUND

• Fantasia KL, Wirunsawanya K, Lee C, Rizo I. Racial Disparities in Diabetes Technology Use and Outcomes in Type 1 Diabetes in a Safety-Net Hospital. J Diabetes Sci Technol. 2021 Sep;15(5):1010-1017. doi: 10.1177/1932296821995810. Epub 2021 Mar 10.

  PMID: 33719610 BACKGROUND

• Aljedaani SM, Siddiqui AS, Raja-Khan N. 678-P: Racial and Ethnic Disparities in CGM Use among Adults with Diabetes. Diabetes. 2022;71(Supplement_1).

  BACKGROUND

• Blonde L, Umpierrez GE, Reddy SS, McGill JB, Berga SL, Bush M, Chandrasekaran S, DeFronzo RA, Einhorn D, Galindo RJ, Gardner TW, Garg R, Garvey WT, Hirsch IB, Hurley DL, Izuora K, Kosiborod M, Olson D, Patel SB, Pop-Busui R, Sadhu AR, Samson SL, Stec C, Tamborlane WV Jr, Tuttle KR, Twining C, Vella A, Vellanki P, Weber SL. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. Endocr Pract. 2022 Oct;28(10):923-1049. doi: 10.1016/j.eprac.2022.08.002. Epub 2022 Aug 11.

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• 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.

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• Norman GJ, Paudel ML, Parkin CG, Bancroft T, Lynch PM. Association Between Real-Time Continuous Glucose Monitor Use and Diabetes-Related Medical Costs for Patients with Type 2 Diabetes. Diabetes Technol Ther. 2022 Jul;24(7):520-524. doi: 10.1089/dia.2021.0525. Epub 2022 Apr 27.

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• Karter AJ, Parker MM, Moffet HH, Gilliam LK, Dlott R. Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes. JAMA. 2021 Jun 8;325(22):2273-2284. doi: 10.1001/jama.2021.6530.

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  BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Emily Schmied,, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Shiloh Williams, PhD RN

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie L Pickrel, MPH

CONTACT

1+ 619-594-3369; jpickrel@sdsu.edu

Nicole Rivera

CONTACT

1+ (760)-768-5549; Nrivera3@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 15, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: To be determined
• Access Criteria: To be determined

Locations

US (2)