Role and Perspective of Certified Diabetes Care and Education Specialists in the Development of the 4T Program Free

All pediatric patients aged 1–21 years within the first 30 days of a type 1 diabetes diagnosis are eligible for the 4T program. Stanford Children’s cares for all children up to 21 years of age. The average age of type 1 diabetes onset in the 4T program is 9.7 years (5). The CDCES team adjusts DSMES to the age of each youth and family as needed.

The 4T study team developed systematic workflows to offer equitable access to the 4T program to all youth newly diagnosed with type 1 diabetes, regardless of age, insurance status, language spoken, provider referral, or other social determinants of health. Spanish-speaking CDCESs and/or the use of hospital interpretation services facilitate access to the program for non–English-speaking patients and families. The program is approved by Stanford’s institutional review board (IRB), and all participants provide written informed consent.

Consented youth are started on CGM within the first month of diagnosis. The 4T program’s main funding is from the National Institute of Diabetes and Digestive and Kidney Diseases pragmatic research trial mechanism, which encourages the development of care approaches that can be translated to other diabetes programs.

The 4T program protocol has been described previously (4,5). Briefly, all youth with newly diagnosed type 1 diabetes are offered the opportunity to start CGM in the first month of diagnosis and have a 1-week follow-up visit with a CDCES (either in person or virtually) to initiate CGM. Stanford Children’s has an American Diabetes Association (ADA)-recognized DSMES program. Starting in March 2019, as part of a 12-month study, 4T study participants also are offered remote monitoring of CGM data by the CDCES team (ClinicalTrials.gov identifier NCT03968055) (5). Using its ADA-approved curriculum, the CDCES team provides DSMES at the initial teaching session when a person is diagnosed with type 1 diabetes. Quality improvement (QI) methodology was used to determine the timing of CGM initiation (within 30 days) and follow-up education (a 1-week CGM follow-up visit) as well as RPM throughout the 12-month study period (Supplementary Appendix S1). 4T program participants receive weekly CGM data review by a CDCES and are sent secure electronic medical record (EMR)-based portal messages with DSMES and dose changes. Workflows were designed and iterated based on feedback from nurse practitioners (NPs) and the CDCES team to determine the most advantageous workflow for the team (Figure 1), assess the effectiveness of DSMES for families, and develop a scalable process for CGM review. All CDCESs participate in CGM initiation and DSMES. Four CDCESs are involved in CGM data review (i.e., RPM). The CDCES team meets weekly to discuss how best to support the families with the new technology, and QI processes and evaluations are continuous.

The 4T program provides an iPod touch to families who do not have a compatible smart device and a 1-month supply of CGM supplies, with additional CGM supplies provided over the course of the 12-month study if insurance coverage is not obtained. The CGM supplies for the first month (i.e., a transmitter, three sensors, and a receiver for each patient) are provided by Dexcom, and grants from the National Institutes of Health provide additional supplies and iPod touches, when needed.

To assess CDCES satisfaction with the 4T program, an IRB-approved survey was sent via REDCap (Research Electronic Data Capture) to the CDCESs who participated in the program. Survey data were collected anonymously and analyzed in Microsoft Excel.

After the initial implementation of the 4T program, the CDCES team met weekly and agreed that the following areas were in need of improvement.

• The approach to the 4T program appeared to be overwhelming to many parents and youth with new-onset type 1 diabetes.

• CGM follow-up was needed to provide more DSMES on the use of CGM.

• Authorizations were needed to assist with securing future supplies.

• Data reviews using Dexcom Clarity, the manufacturer’s Cloud-based platform, were time-consuming for the CDCES staff.

The learning curve is steep for children newly diagnosed with type 1 diabetes and their families. The concerns from the CDCES team were that adding CGM initiation in the first month was making this learning curve even steeper. Focus groups were conducted with 4T participants about the early CGM initiation, and it was shown to be well received by children and highly beneficial to families (6,7). However, given the number of calls the on-call team was receiving, the CDCES team implemented more DSMES to support families. A CGM follow-up appointment was added to the protocol. This visit is usually a telehealth appointment with an NP or a CDCES. The CGM follow-up appointment focuses on how to get CGM coverage renewals and sensor replacements, how to change the first sensor, what we look at when we review the data, and goals for time in range. The CDCESs and NPs developed a handout to support the DSMES occurring at the CGM follow-up appointment. Additionally, the CDCES team developed a handout to address questions and concerns that quickly arose from the families starting early CGM. A diabetes Family Advisory Council (FAC) comprising four parents who have children with type 1 diabetes and one young adult with type 1 diabetes seen at Stanford Children’s reviewed all handouts for readability and understanding. Based on its feedback and questions from families during the DSMES sessions, the CDCES team refined the educational content of each of the scheduled appointments and handouts.

As part of a QI process, the CDCES team iteratively reviewed the timing of CGM education and initiation. A subset of CDCESs discussed and initiated CGM during the new-onset visit. However, the initiation of the CGM extended the day by 1 hour, and the DSMES was suboptimal. The team now discusses CGM and provides a flyer about the 4T program during the initial teaching session. The endocrinology clinical fellow making calls to patients’ families during the first week after diagnosis is then able to follow up with the families and answer questions. This workflow allows time for families to learn about the program and consider participating. The CGM initiation is then scheduled for 1–2 weeks after the new-onset DSMES session.

The CGM initiation and follow-up appointments can be booked to meet the needs of each family and can be completed in person or via telehealth. The CDCESs and families decide on the best cadence for these initial appointments with the goal of scheduling them all during or within the first month after the initial DSMES session. This strategy creates many opportunities for touch points to continue educating the families about the new diagnosis. These frequent appointments also build strong relationships between the families and the CDCES team so that educational messages are well received and implemented.

It was challenging to obtain insurance approval initially, although this situation improved after the team hired a pharmacy technician to assist with the prior authorization process. The CDCES team and pharmacy technician did several rounds of workflow iterations to develop effective workflows for prior authorizations and letters to insurance companies to address barriers to insurance approval and sustained CGM coverage. Having the pharmacy technician focus on prior authorizations and letters to insurance companies supported the CDCESs’ ability to focus on RPM and thus work at the top of their license.

The CDCES team used the Dexcom Clarity platform data to review glucose trends and then communicate with families weekly with suggested insulin dose changes and additional DSMES. As the program grew, the CDCESs and Systems Utilization Research for Stanford Medicine (SURF) engineering teams met monthly to develop a population health management platform called Timely Intervention for Diabetes Excellence (TIDE) to expedite review and focus on patients most in need of CDCES support (10–14).

TIDE is an open-source platform that provides algorithm-enabled prioritization of participants who would benefit from CGM review (10,13). The platform developed by the engineers with input from the CDCES team generates a variety of CGM metrics and highlights the patients with metrics out of range, such as too many glucose values <70 mg/dL or a below-target percentage of time in range (TIR; defined as 70–180 mg/dL with a goal of ≥70% TIR) (3,5). The CDCES team determined that TIR <70%, glucose in the hypoglycemic range >4% of the time, and decrease in TIR were the key metrics that would prompt flags/alerts for data review. Thus, CDCES feedback contributed to the development of this population health platform to facilitate and prioritize CGM data review. The platform helped the CDCES team define a workflow (Figure 1) that allows for the growth of this program without increasing the number of CDCESs on the team.

Each member of the CDCES team has a list of youth populated in the TIDE dashboard for CGM data review each week. The volume of patients increased over time (from 2018 to the present) as the 4T study evolved; the pilot study included 89 RPM participants, study 1 included 133 RPM participants, and study 2 (currently enrolling) includes 98 RPM participants to date (5,18). Messages sent to the families include dose changes, behavioral changes, and ideas to support and assist in reaching the glycemic target range (70–180 mg/dL) at least 70% of the time with <4% of time with glucose <70 mg/dL and <1% of time <55 mg/dL (19). The dose changes suggested are made within the CDCES scope of practice using a protocol developed by Stanford Children’s based on national Association of Diabetes Care and Education Specialists standards (20,21). The effectiveness of DSMES and dose changes is evaluated by the CDCES doing each patient’s RPM, based on the patient or family’s engagement with the CDCES team, questions from the family, and changes in TIR.

The creation of the TIDE dashboard has allowed for more RPM each week. Individual CDCESs now review up to 28 patients per week, spending an average of 2–4 hours per week each on RPM. The research team and SURF engineering team run analyses of how often the CDCESs send messages to assist with workflow and determine the frequency with which the team needs to review data. The CDCES team continues to review the workflow and make improvements. The CDCESs bill for time spent for the initial new-onset education, CGM initiation, and CGM follow-up visits, but not for RPM, although such billing may be implemented in the future.

The TIDE platform also provides a quick overview of patients decreasing their CGM wear time, which is often a result of struggles obtaining supplies because of gaps in insurance coverage. Prior authorizations, documentation of improved glycemic outcomes, and formal meetings between providers and the leadership of California’s public insurance program (22) reduced CGM supply issues for families over the course of the study. Clear documentation of glycemic outcomes helped with advocacy efforts in formalizing CGM coverage for youth with the California Children’s Services program. Increased coverage, combined with more efficient completion of prior authorizations, has helped to reduce CGM supply issues for youth over the course of the study. The CDCESs can now address such insurance and supply issues before individuals pause or stop their sensor wear.

As the program continues to grow, standardized EMR-based phrases are being created so each team member uses similar wording to communicate the status of glucose trends and goals to families. Using standardized EMR-based phrases allows for more efficient communication with patients and families; however, voice calls are used if there is a language or health literacy barrier. CDCESs will also make calls if families prefer phone communication.

CDCESs send the initial electronic messages (Supplementary Appendix S2) and then, if parents or patients send a reply, a thread of communication forms. The number of messages depends on the family, as the level of engagement affects the number of electronic messages sent. The CDCES team continues to develop iterations of the wording for the electronic messages (Supplementary Appendix S2) and to refine the handouts (Supplementary Appendices S3 and S4) provided at the CGM initiation and follow-up appointments.

Future goals of the 4T program are to scale it to become the standard of care at all Stanford Children’s diabetes clinics and to disseminate and implement the program, including an RPM dashboard, to clinics outside of Stanford. These efforts are ongoing through various collaborations and grant proposals.

The REDcap satisfaction survey was completed by 90% of the CDCESs. One-third (n = 3) felt that the process of starting CGM on all patients with new-onset type 1 diabetes and having a 1-week follow-up added burden to their workload. Another 44% (n = 4) felt that weekly CGM reviews added to their workload. However, all CDCES respondents felt that the 4T program supports the needs of patients and families, empowers CDCESs, and is rewarding for the CDCES team (Figure 2).

To meet the evolving care and education needs of the expanding population of people with diabetes, the role of CDCESs in therapeutic management in today’s technology-driven care system should expand so these professionals can work at the top of their license. The 4T study adds to the literature in support of this strategy (23,24). The input and work of the CDCES team has created a sustainable process for early CGM initiation and RPM in youth with newly diagnosed type 1 diabetes. The CDCES team continues to make this program successful. CDCES teams should play an essential role in all program development for the care of youth with type 1 diabetes. The 4T program is successful because of the hard work of the entire professional team, including invaluable input from the CDCES team in providing DSMES and RPM and developing the handouts, a workflow, and a scalable process.

Ensuring that CDCES has scheduled and uninterrupted time to review their patient cohort continues to be a challenge; as a team, the CDCESs continue to work on meeting this challenge and supporting each other. The availability of support staff (i.e., the pharmacy technician) hired to assist with prior authorizations and prescriptions has freed up more time for the CDCESs to work at the top level of their license in providing families with DSMES, RPM, and insulin adjustment suggestions to maintain optimal glucose levels.

In team discussions, there is a general consensus that the program has been successful; there has been a drop in A1C and an increase in the number of youth initiating and continuously wearing CGM sensors (5–9,18). The CDCES team hypothesizes that early CGM initiation destigmatizes the wearing of devices in youth with type 1 diabetes. Studies are underway to determine whether the CDCES team can help youth remain on CGM after the first year of diagnosis and document the increased persistence of use that has been observed anecdotally. The team often celebrates small wins, such as when devices are approved and worn, and larger ones, such as the achievement of tighter glucose trends.

Although the 4T program adds CDCESs’ workload, all of the CDCES team members think the program is beneficial to patients and families and rewarding for themselves. Incorporating CDCESs’ perspectives into program development can lead to both more successful diabetes care programs and increased job satisfaction.

The authors acknowledge all of the participants and families involved in the 4T program study. They also thank the staff and team members involved in the program, including Priya Prahalad, Korey Hood, Ananta Addala, Ramesh Johari, Manisha Desai, Victoria Ding, Victor Ritter, Blake Shaw, Nora Arrizon-Ruiz, Liz Heckard, Dom Mitchell, Ana Cortes, Andrea Ospina Bonilla, Rebecca Gardner, Carolyn Herrera, Julie Hooper, Alex Freeman, Esli Osmanlliu, Erica Pang, Natalie Pageler, Molly Tanenbaum, Rachel Tam, Ilenia Balistreri, Noor Alramahi, and Alondra Loyola. Finally, the authors thank the SURF engineering students who contributed to the development and deployment of the platform that facilitated RPM, including Oseas Oyardi, Angela Gu, Josh Grossman, Jacqualine Jil Valon, Anastasiya Vitko, Dianelys Perez Morales, Daniel Jun, Ryan Leonard, Michael Zikai Gao, Annie Chang, Prashant Yadav, Isha Thapa, and Johannes Opsahl Ferstad.

This work was supported in part by National Institutes of Health (NIH) grants P30DK116074 via the Stanford Diabetes Research Center and R18DK122422 to D.M.M. CGM supplies for participants’ first month of CGM were donated by Dexcom. Funding for iOS devices and some CGM supplies was provided by a grant from the Lucile Packard Children’s Hospital Auxiliaries Endowment.

D.M.M. has received research support from the JDRF, NIH, National Science Foundation, and Leona M. and Harry B. Helmsley Charitable Trust; has received research support from Bigfoot Biomedical, Dexcom, Insulet, Medtronic, Roche, and Tandem Diabetes; has consulted for Abbott, Eli Lilly, Leona M. and Harry B. Helmsley Charitable Trust, Insulet, Novo Nordisk, and Sanofi; and is supported by NIH grant P30DK116074. No other potential conflicts of interest relevant to this article were reported.

J.C.L. wrote the manuscript and researched data. B.L., P.S., A.M.-S., B.C., and A.C. researched data and reviewed and edited the manuscript. P.P., F.K.B., D.S., and D.M.M. contributed to the discussion and reviewed and edited the manuscript. J.S. reviewed and edited the manuscript. J.C.L. and D.M.M. are the guarantors of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.