Past and Present Diabetes Studies

How SWDI leverages expertise and technology to develop creative, cost-effective solutions in diabetes care

Staff of N. Paul Whittier Clinical Diabetes Research Center give a thumbs up - La Jolla, California

N. Paul Whittier Clinical Diabetes Research Center staff in La Jolla, California.

How SWDI leverages expertise and technology to develop creative, cost-effective solutions in diabetes care

The primary aim of research at Scripps Whittier Diabetes Institute is to develop new programs, explore new medications and create unique solutions to enhance the quality of life for individuals with diabetes through both investigator-initiated and commercially-sponsored clinical research studies.


The research teams at Scripps Whittier Diabetes Institute have focused on conducting community-based participatory research for over 25 years and lead the Community and Collaboration Core for the Clinical Translational Science Award at Scripps Research Translational Institute. 


Our clinical research team, based on the campus of Scripps Memorial Hospital La Jolla, partners with expert physicians within the Scripps Clinic Medical Group to offer access to the latest studies with medications and technologies to improve care for people with diabetes.  


Investigator-initiated projects

Researcher investigators, physicians, patients, and other stakeholders work closely together at Scripps Whittier Diabetes Institute to invent creative, integrative, and practical solutions to unaddressed issues in diabetes care and management through funding from investigator-initiated research projects. Whittier is at the leading edge of the development of more effective, cost-effective, and pragmatic approaches to improving clinical outcomes in diabetes.


The overarching goal of investigator-initiated research is to improve the quality of and patients’ access to diabetes care by developing new programs and enhancing or adapting existing treatments. 


Cross-cutting project themes are: 


  • Leveraging technology 
  • Using team-based care models 
  • Developing new, creative solutions to long-standing barriers in clinical care that contribute to health disparities in diabetes


Our interdisciplinary research team — including investigators, endocrinologists, psychologists, nurses, diabetes educators and other research staff — has a strong track record of success in obtaining funding for these projects from NIH, donations, pharmaceutical companies and other industry partners. Over the past five years, Scripps Whittier Diabetes Institute has received over $1.5 million annually from NIH alone to fund investigator-initiated research studies. 

Diabetes research scientists at Scripps Whittier Diabetes Institute.

Diabetes research scientists at Scripps Whittier Diabetes Institute. Investigators from left to right: Athena Philis-Tsimikas, MD; Emily Soriano, PhD; Samantha Speirling Bagsic, PhD; Emily San Diego, PhD; and Addie Fortmann, PhD.

Current investigator-initiated projects

One in three adults hospitalized in California has diabetes. Poor blood sugar control in the hospital is common and can lead to serious complications for patients and longer lengths of stay. This randomized controlled trial tests a new, dynamic, digitized, team-based approach to hospital glucose management: Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS). This large-scale study (N = 554) tests Cyber GEMS in the hospital environment in an underserved and understudied, yet high-risk population—predominantly low-income, Hispanic adults with type 2 diabetes. In Cyber GEMS, real-time continuous glucose monitoring (CGM) data is transmitted to a Digital Dashboard to facilitate 24/7, real-time remote monitoring for potentially dangerous hypoglycemic (i.e., severe low blood sugar) episodes. Achieving and maintaining good blood sugar control among hospitalized patients with diabetes is imperative. Cyber GEMS was specifically designed to address this problem, and to improve care quality and clinical outcomes that are highly important to our patients. 


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute) & Addie L. Fortmann, PhD (Scripps Health) 


Co-Investigators: Laura Talavera, MSN, MPH, RN CNS-bc (Scripps Whittier Diabetes Institute), Samantha Spierling Bagsic, PhD (Scripps Health) & Laura Nicholson, MD/PhD (Scripps Research)


Collaborators: Jill Waalen, MD, MPH (Scripps Research) & Todd Gilmer, PhD (UC San Diego)


Community Partners: N/A



Related publications and presentations: 

  1. Fortmann AL, Spierling Bagsic SR, Talavera L, et al. Glucose as the fifth vital sign: A randomized controlled trial of continuous glucose monitoring in a non-ICU hospital setting. Dia Care. 2020;43(11):2873-2877. doi:10.2337/dc20-1016
  2. Fortmann AL. Inpatient use of continuous glucose monitoring to improve hyperglycemia. Oral presentation at: American Diabetes Association 81st Scientific Sessions; June, 2021; virtual meeting.
  3. Garcia MI, Talavera, L, Fortmann, AL, et al. Use of remote digital monitoring by glucose management teams in hospitalized high-risk patients to reduce hypo- and hyperglycemia. Oral presentation at: American Diabetes Association 77th Scientific Sessions; June, 2017; San Diego, CA. doi:10.2337/db14-1-388

More than a third of people with diabetes experience significant diabetes distress, or the understandable emotional burden of managing a demanding chronic condition on a daily basis. Diabetes distress is, in turn, related to poorer diabetes self-care and glucose control. Previously tested interventions for diabetes distress have been effective in reducing emotional overwhelm but not in improving blood glucose levels. This large-scale randomized controlled trial (N = 484) tests a new telemedicine intervention for diabetes distress that uses an Acceptance and Commitment Therapy (ACT) approach — ACT1VATE. This project compares ACT1VATE versus usual care in improving clinical, behavioral, psychosocial, process, and cost outcomes over 12 months among people. It will be tested among adults with type 1 diabetes, who are experiencing significant diabetes distress and poor glycemic control. In line with the American Diabetes Association’s recommendation to address diabetes distress as part of routine diabetes care, this study tests a new approach for supporting our patient’s emotional needs to managing diabetes distress and poor glucose control by enhancing existing systems of care for diabetes in a real-world setting.


Principal Investigators: Addie L. Fortmann, PhD (Scripps Health) & Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute)


Co-Investigators: Emily Soriano, PhD (Scripps Health)


Collaborators: Jill Waalen, MD, MPH (Scripps Research), Niloofar Afari, PhD (UC San Diego), Todd Gilmer, PhD (UC San Diego), William H. Polonsky, PhD, CDCES (Behavioral Diabetes Institute)


Community Partners: N/A



Related Publications and Presentations:

  1. Fortmann AL, Skidmore JR, Euyoque J, et al. An integrated approach for addressing behavioral health needs in diabetes improves glycemic control. Poster presented at: American Diabetes Association 77th Scientific Sessions; June, 2017; San Diego, CA.

Communities of color are at greater risk for developing diabetes and diabetes-related complications and unfortunately, also experience more barriers to accessing health care. Our team previously developed a culturally-tailored diabetes education and digital text messaging program — Project Dulce and Dulce Digital — for the Hispanic population. This suite of research programs will assess the feasibility, acceptability and effectiveness of various modalities for delivering diabetes education programs, i.e., live group, video group or through digital text messaging in Hispanic populations, and will test these methods in other communities at equally high prevalence of diabetes-Filipino and Middle Eastern populations.


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute), Emily San Diego, PhD (Scripps Whittier Diabetes Institute), Ahmed Khattab, MD (Scripps Research)


Co-Investigators: N/A


Collaborators: Monica Ruiz (Scripps Whittier Diabetes Institute), Samantha Spierling Bagsic, PhD (Scripps Health). Beth Pyatak, PhD (USC), Barbara Turner, MD (USC), Eric Leven, MBA (Rip Road, Inc.)


Community Partners: San Ysidro Health 

Past investigator-initiated projects

Hispanic adults are at greater risk for developing diabetes and diabetes-related complications and unfortunately, also experience more barriers to accessing health care. Our team previously developed a culturally-tailored diabetes education program — Dulce Digital — specifically for this group. This project tests an enhanced version of Dulce Digital in response to previous participants’ requests for a more tailored, personalized version of the treatment. The new program, Dulce Digital-Me, includes Dulce Digital program components (educational text messages and remote-monitoring of blood glucose values) plus personalized goal-setting and feedback to tailor text messaging content to individuals’ behavioral progress and ever-changing context. This large-scale randomized trial includes N = 414 Hispanic adults of low socioeconomic status with poorly controlled type 2 diabetes over a 12-month period. This project will help clarify how technology can be most effectively and efficiently integrated into primary care to reduce diabetes disparities in this high-risk group of Hispanic adults.


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute) & Linda C. Gallo, PhD (San Diego State University)

Co-Investigators: Addie L. Fortmann, PhD (Scripps Health), Todd Gilmer, PhD (UC San Diego), Job Godino, PhD (UC San Diego), Emilia Farcas, PhD (UC San Diego)


Collaborators: N/A


Community Partners: Neighborhood Healthcare



Related Publications and Presentations:

  1. Philis-Tsimikas, A., Fortmann, A.L., Godino, J.G. et al. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Trials 23, 80 (2022). https://doi.org/10.1186/s13063-021-05899-x
  2. Paul T, Mehawej J, Philis-Tsimikas A, Digital health tools to promote diabetes education and management of cardiovascular risk factors among under-resourced populations. Cardiovascular Digital Health Journal, Open Access Published: September 30, 2021 DOI: https://doi.org/10.1016/j.cvdhj.2021.09.005
  3. Fortmann AL, Gallo LC, Garcia MI, et al. Dulce Digital: An mHealth SMS-based intervention improves glycemic control in Hispanics with type 2 diabetes. Dia Care. 2017;40(10):1349-1355. doi: https://doi.org/10.2337/dc17-0230
  4. Fortmann AL, Garcia MI, Skidmore J, et al. Diabetes distress affects responsiveness to an mHealth self-management intervention among Hispanics with type 2 diabetes (Dulce Digital). Moderated poster presented at: American Diabetes Association 76th Scientific Sessions; June, 2016; New Orleans, LA.

Hispanic adults with diabetes are disproportionately affected by COVID-19 — they experience greater rates of infection and are more likely to experience serious illness and mortality due to COVID-19. Good diabetes self-care and day-to-day glucose control are key to reducing these risks, but pandemic-related stay-at-home orders and changes in healthcare protocols have made this more challenging. Supported by a supplement award to Dulce Digital-Me, this randomized controlled trial tests a timely update to our previously developed program, Dulce Digital — a proven-effective combination of “one-size-fits-all” educational text messages and nurse monitoring of patient-transmitted blood glucose values. The new program, Dulce Digital-COVID Aware, incorporates additional education specifically aimed to reduce rates of COVID-19 transmission in high-risk Hispanics with type 2 diabetes during a highly vulnerable period post-discharge from Scripps Mercy Hospital, Chula Vista. Dulce Digital-COVID Aware offers an ideal low-cost and flexible solution to reduce hospital admissions and re-admissions in US/Mexico border communities that are significantly affected by both type 2 diabetes and COVID-19.


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute) & Addie L. Fortmann, PhD (Scripps Health)


Co-Investigators: N/A


Collaborators: Laura Talavera, MSN, MPH, RN CNS-bc (Scripps Whittier Diabetes Institute), Samantha Spierling Bagsic, PhD (Scripps Health), Ghazala Sharief, MD (Scripps Health), Monica Ruiz, MA (Scripps Whittier Diabetes Institute), Eric Leven, MBA (Rip Road, Inc.)


Community Partners: N/A



Related Publications and Presentations: 

  1. Philis-Tsimikas, A., Fortmann, A.L., Godino, J.G. et al. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Trials 23, 80 (2022). https://doi.org/10.1186/s13063-021-05899-x
  2. Paul T, Mehawej J, Philis-Tsimikas A, Digital health tools to promote diabetes education and management of cardiovascular risk factors among under-resourced populations. Cardiovascular Digital Health Journal, Open Access Published: September 30, 2021 DOI: https://doi.org/10.1016/j.cvdhj.2021.09.005
  3. Fortmann AL, Gallo LC, Garcia MI, et al. Dulce Digital: An mHealth SMS-based intervention improves glycemic control in Hispanics with type 2 diabetes. Dia Care. 2017;40(10):1349-1355. doi: https://doi.org/10.2337/dc17-0230
  4. Fortmann AL, Philis-Tsimikas A, Bagsic SR, et al. Dulce Digital-Me: An adaptive m-health intervention for underserved Hispanics with diabetes. Poster presented at: American Diabetes Association 80th Scientific Sessions; June, 2020; virtual meeting.
  5. Fortmann AL, Garcia MI, Skidmore J, et al. Diabetes distress affects responsiveness to an mHealth self-management intervention among Hispanics with type 2 diabetes (Dulce Digital). Moderated poster presented at: American Diabetes Association 76th Scientific Sessions; June, 2016; New Orleans, LA.

Hispanic adults are at particularly high risk of having diabetes plus other troubling conditions, including other cardiometabolic conditions (e.g., heart disease) and mental health concerns (e.g., depression, anxiety). This large-scale randomized controlled trial tests a new program — Mi Puente (My Bridge) — tailored for and designed specifically to reach 560 Hispanic adults with multiple cardiometabolic conditions and behavioral health concern(s). The project will compare the effectiveness of Mi Puente and usual care in reducing these patients’ future hospital admissions and improving their physical health and quality of life. Mi Puente is a team-based, interdisciplinary intervention that helps support patients and caregivers during their transition from a hospitalization at Scripps Mercy Hospital to 30 days post-discharge from the hospital. The program involves inpatient hospital coaching visits, post-discharge support phone calls and volunteer community mentorship. As a low-cost program that uses existing hospital-based resources, Mi Puente has strong potential to improve health disparities for Hispanic adults who often do not receive adequate cardiometabolic and mental health care.


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Health) & Linda C. Gallo, PhD (San Diego State University)


Co-Investigators: Addie L. Fortmann, PhD (Scripps Health) & Laura Talavera, MSN, MPH, RN CNS-bc (Scripps Health)


Collaborators: N/A


Community Partners: Chula Vista Community Collaborative & San Ysidro Health



Related Publications and Presentations:

  1. Gallo, L.C., Fortmann, A.L., Bravin, J.I. Philis-Tsimikas, A. et al. My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial. Trials 21, 174 (2020). https://doi.org/10.1186/s13063-019-3722-8
  2. Gallo LC, Fortmann AL, Bravin JI, et al. My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: Protocol for a randomized controlled trial. Trials. 2020;21(1):174. doi:10/ghpdd3
  3. Philis-Tsimikas A, Fortmann AL, Dharkar-Surber S, et al. Dulce Mothers: An intervention to reduce diabetes and cardiovascular risk in Latinas after gestational diabetes. Behav Med Pract Policy Res. 2014;4(1):18-25. doi:10/gjf2gd
  4. Gallo LC, Fortmann AL, Roesch SC, et al. Socioeconomic status, psychosocial resources and risk, and cardiometabolic risk in Mexican-American women. Health Psychology. 2012;31(3):334-342. doi:10/bmdh6w
  5. Philis-Tsimikas A, Hoagland-Fuchs N, Walker C, Fortmann AL. Dulce Transitions: Peer health coaches reduce hospital readmission rates in high-risk Latinos. Poster presented at: American Diabetes Association 74th Scientific Sessions; June, 2014; San Francisco, CA. 
  6. Bravin JI, Anderson ML, Clark T, et al. Mi Puente: A care transitions intervention for at-risk Hispanics with multiple cardiometabolic conditions. Poster presented at: American Diabetes Association 79th Scientific Sessions; June, 2019; San Francisco, CA.
  7. Fortmann AL, Gallo LC, Espinosa de los Monteros K, et al. Socioeconomic status and cardiometabolic risk in middle-aged Mexican-American women. Oral presentation at: 69th Annual Scientific Meeting of the American Psychosomatic Society; March, 2011; San Antonio, TX. 

Diabetes education is a core component of standard care for all adults diagnosed with diabetes, yet a huge portion of these patients never actually receive this resource or drop out quickly after starting. This study aimed to transform the standard approach to diabetes education by adding real-time flash glucose monitoring (FGM) to help patients understand the impact of diet, exercise, medication and stress on their glucose levels in real-time. This project tests the effectiveness of this enhanced diabetes education program on glucose control, diabetes self-management behaviors, quality of life and satisfaction with the program. In this single-group pilot study, this web-based diabetes education + FGM program will be provided to 32 adults with type 2 diabetes whose HbA1C is greater than 8%. This project has the potential to transform the current standard models of diabetes care by leveraging increasingly available technology for monitoring glucose values in real time.


Principal Investigators: Addie L. Fortmann, PhD (Scripps Health) & William H. Polonsky, PhD, CDCES (Behavioral Diabetes Institute)


Co-Investigators: N/A


Collaborators: Susan Guzman, PhD (Behavioral Diabetes Institute) & Martha Funnell, MS, RN, CDE, FAAN (University of Michigan)


Community Partners: N/A


  • Funder: Abbott Diabetes Care 
  • Status: COMPLETED /2021-2022
  • ClinicalTrials.gov link: N/A


Related Publications and Presentations:

  1. Polonsky WH, Fortmann AL. Impact of real-time CGM data sharing on quality of life in the caregivers of adults and children with type 1 diabetes. J Diabetes Sci Technol. Published online December 16, 2020:1932296820978423. doi: 10/gmchz2
  2. Polonsky WH, Fortmann AL. Impact of real-time continuous glucose monitoring data sharing on quality of life and health outcomes in adults with type 1 diabetes. Diabetes Technology & Therapeutics. Published online September 29, 2020:dia.2020.0466. doi: 10/ghjthk
  3. Fortmann AL, Bastian A, Lensing CJ, et al. 2180-PUB: Integration of continuous glucose monitoring in diabetes self-management education for type 2 diabetes improves glycemic control. Diabetes. 2020;69(Supplement 1):2180-PUB. doi: 10.2337/db20-2180-PUB
  4. Fortmann AL, Polonsky WH, Kurtukova T, et al. Impact of real-time CGM data sharing on quality of life in adults with type 1 diabetes. Poster presented at: 56th Annual Meeting of the European Association for the Study of Diabetes; September, 2020; virtual meeting.

Blood glucose can be challenging to manage in the hospital. Part of the challenge is that the standard approach to testing blood glucose in this setting (point-of-care testing) provides an incomplete picture of glucose levels during the day and night for hospitalized patients. This randomized controlled trial examined CGM as tested a new program that provides patients with type 1 and high-risk type 2 diabetes a safer hospitalization by using continuous glucose monitoring (CGM) devices to track their glucose in real-time, like other continuously monitored vital signs (e.g., heart rate, blood pressure). CGM allows a whole team of providers to easily monitor patients' progress, make recommendations, and initiate discussion when recommended blood glucose targets are not met. Incorporating CGM in the hospital setting using a team-based approach has enormous potential to reduce rates of morbidity, mortality and even health care costs that are strongly associated with poorly controlled blood glucose — a difficult problem to solve using the current point-of-care testing approach. Preliminary results of this study showed that patients who participated in this new inpatient CGM program had more healthy glucose levels than patients in usual care (point-of-care testing).


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute)


Co-Investigators: Addie Fortmann, PhD (Scripps Health) & Laura Talavera, MSN, MPH, RN CNS-bc (Scripps Whittier Diabetes Institute)


Collaborators: N/A


Community Partners: N/A



Related Publications and Presentations:

  1. Fortmann AL, Spierling Bagsic SR, Talavera L, et al. Glucose as the fifth vital sign: A randomized controlled trial of continuous glucose monitoring in a non-ICU hospital setting. Dia Care. 2020;43(11):2873-2877. doi:10.2337/dc20-1016 
  2. Koziol J, Johnson K, Brenner K, Fortmann A, Morrisey R, Philis-Tsimikas A. Novel approach to inpatient glucometric monitoring and variability in a community hospital setting. J Diabetes Sci Technol. 2015;9(2):246-256. doi: 10/f677xp
  3. Fortmann AL. Inpatient use of continuous glucose monitoring to improve hyperglycemia. Oral presentation at: American Diabetes Association 81st Scientific Sessions; June, 2021; virtual meeting.
  4. Fortmann AL, Bastian A, Bagsic SRS, et al. Feasibility and preliminary effectiveness of continuous glucose monitoring for diabetes prevention. Diabetes. 2020;69(Supplement 1):2175-PUB. doi:10.2337/db20-2175-PUB
  5. Fortmann AL, Bastian A, Lensing CJ, et al. 2180-PUB: Integration of continuous glucose monitoring in diabetes self-management education for type 2 diabetes improves glycemic control. Diabetes. 2020;69(Supplement 1):2180-PUB. doi:10.2337/db20-2180-PUB
  6. Garcia MI, Talavera, L, Fortmann, AL, et al. Use of remote digital monitoring by glucose management teams in hospitalized high-risk patients to reduce hypo- and hyperglycemia. Oral presentation at: American Diabetes Association 77th Scientific Sessions; June, 2017; San Diego, CA. doi:10.2337/db17-1-380
  7. Fortmann AL, Talavera L, Sims D, et al. Poor glucose control in the hospital leads to longer lengths of stay and higher total costs in a large community health system. Oral presentation at: the American Diabetes Association 75th Scientific Sessions, June, 2015; Boston, MA. doi:10.2337/db15-1-385

Diabetes requires ongoing, daily efforts on the part of patients to manage. Unfortunately, type 2 diabetes disproportionately impacts people who already experience many additional barriers to daily diabetes self-care, which is perhaps why underserved populations tend not to receive diabetes education — a cornerstone of effective diabetes care. Moreover, a practical barrier to health care systems providing this important part of diabetes treatment is that diabetes education is simply too complex for primary care physicians to address in the context of their typical 15-minute patient visits. This project was a large-scale randomized controlled trial of the real-world effectiveness and sustainability of different approaches to diabetes education in primary care: the medical assistant health-coaching program (MAC) trained health coaches to team up with primary care providers to deliver diabetes education to 600 adults with type 2 diabetes during routine visits at Neighborhood Healthcare and Scripps in San Diego County over a yearlong period. Ongoing, personalized, and diabetes-specific support from health coaches has the potential to drastically improve this diverse group’s ability to manage their diabetes day-to-day — which is challenging enough as is! The outcome analysis for this trial is currently underway.


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute) & Linda C. Gallo, PhD (San Diego State University)


Co-Investigators: Addie L. Fortmann, PhD (Scripps Health)


Collaborators: James Schultz, MD (Neighborhood Healthcare) & Thomas Bodenheimer (UC San Francisco)


Community Partners: Neighborhood Healthcare



Related Publications and Presentations:

  1. Fortmann AL, Philis-Tsimikas A, Euyoque JA, et al. Medical assistant health coaching (“MAC”) for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol. Contemporary Clinical Trials. 2021;100:106164. doi: 10.1016/j.cct.2020.106164
  2. Fortmann AL, Walker C, Barger K, et al. Care team integration in primary care improves one-year clinical and financial outcomes in diabetes: A case for value-based care. Population Health Management. 2020;23(6):467-475. doi: 10.1089/pop.2019.0103
  3. Clark T, Gallo L, Euyoque JA, et al. Tailoring of a pragmatic MA health coaching intervention for diverse T2D populations. Poster presented at: the American Diabetes Association 79th Scientific Sessions; June, 2019; San Francisco, CA.
  4. Fortmann AL, Preciado JL, Walker C, et al. Effects of a primary care-based chronic care model on diabetes self-management, diabetes distress, and healthcare experience. Moderated poster presented at: the American Diabetes Association 78h Scientific Sessions; June, 2018; Orlando, FL.

Hispanic women are more likely to have multiple risk factors for developing type 2 diabetes — in addition to higher rates of gestational diabetes, carrying extra weight and getting insufficient exercise are more common in this historically underserved and disadvantaged group. In this project, we tested a culturally adapted, peer-led education version of the Diabetes Prevention Program (DPP) lifestyle intervention curriculum in two groups of Hispanic women at elevated risk for diabetes: those with a history of gestational diabetes (n = 24; Dulce Mothers program) or with an elevated body mass index (BMI; n = 37; Nuestra Vida program). In addition to examining how this adapted program impacted participants’ physical and mental health and prevented diagnosis of diabetes, this project also evaluated how feasible and acceptable it was viewed by patients. This project provided important information on how and when to best reach Hispanic women to support their health and well-being. The results of this project showed that Dulce Mothers is a low-cost, feasible and acceptable program that can improve Hispanic women’s diet behavior, mental health and body weight.


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute)


Co-Investigators: N/A


Collaborators: Monica Ruiz (Scripps Whittier Diabetes Institute), Linda C. Gallo, PhD (San Diego State University), Addie Fortmann, PhD (Scripps Health)


Community Partners: Neighborhood Healthcare


  • Funder: Confidence Foundation 
  • Status: COMPLETED/2013-2014
  • ClinicalTrials.gov link: N/A


Related Publications and Presentations:

  1. McCurley JL, Fortmann AL, Gutierrez AP, et al. Pilot test of a culturally appropriate diabetes prevention intervention for at-risk Latina women. Diabetes Educ. 2017;43(6):631-640. doi: 10/ggk8xj
  2. Philis-Tsimikas A, Fortmann AL, Dharkar-Surber S, et al. Dulce Mothers: An intervention to reduce diabetes and cardiovascular risk in Latinas after gestational diabetes. Behav Med Pract Policy Res. 2014;4(1):18-25. doi: 10/gjf2gd
  3. Fortmann AL, Gallo LC, Euyoque J, et al. A peer-led, culturally-tailored adaption of the Diabetes Prevention Program for Hispanic women. Poster presented at: the American Diabetes Association 77h Scientific Sessions; June, 2017; San Diego, CA.
  4. Clarine LH, Chang AA, Alegre-Border E, et al. Comparison of maternal and neonatal outcomes using different glycemic targets during pregnancy. Poster presented at: the American Diabetes Association 77h Scientific Sessions; June, 2017; San Diego, CA.
  5. Dharkar-Surber S, Fortmann AL, Euyoque J, et al. Results of peer-led DM prevention program for high-risk Latino women with GDM. Poster presented at: the American Diabetes Association’s Scientific Sessions; June, 2012; Philadelphia, PA.
  6. Dharkar-Surber S, Euyoque J, Gallo LC, et al. Assessment of Dulce Mothers: A formative study in the risk reduction of diabetes after GDM. Poster presented at: the 33rd Annual Meeting of the Society of Behavioral Medicine; April, 2012; New Orleans, LA.

Hispanic adults are at greater risk for developing diabetes and diabetes-related complications and unfortunately also experience more barriers to accessing health care (e.g., work, caregiving, transportation). Our team previously developed a culturally appropriate diabetes self-management and education program — Project Dulce — specifically for this group, but practical barriers to accessing this program still limit its reach to its most vulnerable members. Our team created a text-message-based adaptation of Project Dulce to address these barriers. The Dulce Digital program included culturally-tailored and health literacy-sensitive educational and supportive text messages combined with patient monitoring and transmission of blood glucose values. We found that the Dulce Digital program led to significantly greater reductions in blood sugar levels (HbA1c) in adults with poorly controlled type 2 diabetes, compared to usual care (Fortmann et al., 2017). 


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Health)


Co-Investigators: N/A


Collaborators: Monica Ruiz, (Scripps Whittier Diabetes Institute), Linda C. Gallo, PhD (San Diego State University), Addie Fortmann, PhD (Scripps Health)


Community Partners: Neighborhood Healthcare



Related Publications and Presentations:

  1. Fortmann AL, Gallo LC, Garcia MI, et al. Dulce Digital: An mHealth SMS-based intervention improves glycemic control in Hispanics with type 2 diabetes. Dia Care. 2017;40(10):1349-1355. doi: https://doi.org/10.2337/dc17-0230
  2. Anzaldo-Campos MC, Contreras S, Vargas-Ojeda A, Menchaca-Díaz R, Fortmann A, Philis-Tsimikas A. Dulce Wireless Tijuana: A randomized control trial evaluating the impact of Project Dulce and short-term mobile technology on glycemic control in a family medicine clinic in Northern Mexico. Diabetes Technol Ther. 2016;18(4):240-251. doi:10/f8g3kn
  3. Fortmann AL, Philis-Tsimikas A, Bagsic SR, et al. Dulce Digital-Me: An adaptive m-health intervention for underserved Hispanics with diabetes. Poster presented at: American Diabetes Association 80th Scientific Sessions; June, 2020; virtual meeting.
  4. Fortmann AL, Garcia MI, Skidmore J, et al. Diabetes distress affects responsiveness to an mHealth self-management intervention among Hispanics with type 2 diabetes (Dulce Digital). Moderated poster presented at: American Diabetes Association 76th Scientific Sessions; June, 2016; New Orleans, LA.
  5. Garcia MI, Fortmann AL, Ruiz M, Schultz J, Gallo LC, Philis-Tsimikas A. Dulce Digital: A mobile-based self-management intervention for Latinos with type 2 diabetes. Oral presentation at: American Diabetes Association 74th Scientific Sessions; June, 2014; San Francisco, CA. doi:10.2337/db14-1-388

Hispanic women with a history of gestational diabetes during pregnancy are a particularly underserved group with elevated risk for developing type 2 diabetes and heart disease. This was a single-group pilot trial of Dulce Mothers, a Diabetes Prevention Program-adapted lifestyle intervention designed to reduce the risk of type 2 diabetes and cardiovascular disease in low socioeconomic-status Hispanic women with a history of gestational diabetes. Dulce Mothers built on our previously developed program, Project Dulce, by emphasizing bicultural/bilingual peer-delivered group education to increase the relevance and reach of the program to this specific group of at-risk Hispanic women. Eighty-four participants received Dulce Mothers and were followed for six months to evaluate the impact of participating on their health outcomes. This project was an important step in establishing that this innovative version of the Diabetes Prevention Program specifically adapted for Hispanic women with critical health risk factors is effective and feasible for health systems to incorporate into standard models of care. The results of this project showed that the Dulce Mothers program was feasible, acceptable and improved some aspects of diabetes and cardiovascular disease rates among Hispanic women with a history of gestational diabetes.


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute)


Co-Investigators: N/A


Collaborators: Monica Ruiz (Scripps Whittier Diabetes Institute), Linda C. Gallo, PhD (San Diego State University), Addie Fortmann, PhD (Scripps Health)


Community Partners: Neighborhood Healthcare



Related Publications and Presentations:

  1. McCurley JL, Fortmann AL, Gutierrez AP, et al. Pilot test of a culturally appropriate diabetes prevention intervention for at-risk Latina women. Diabetes Educ. 2017;43(6):631-640. doi: 10/ggk8xj
  2. Philis-Tsimikas A, Fortmann AL, Dharkar-Surber S, et al. Dulce Mothers: An intervention to reduce diabetes and cardiovascular risk in Latinas after gestational diabetes. Behav Med Pract Policy Res. 2014;4(1):18-25. doi: 10/gjf2gd
  3. Fortmann AL, Gallo LC, Euyoque J, et al. A peer-led, culturally-tailored adaption of the Diabetes Prevention Program for Hispanic women. Poster presented at: the American Diabetes Association 77h Scientific Sessions; June, 2017; San Diego, CA.
  4. Clarine LH, Chang AA, Alegre-Border E, et al. Comparison of maternal and neonatal outcomes using different glycemic targets during pregnancy. Poster presented at: the American Diabetes Association 77h Scientific Sessions; June, 2017; San Diego, CA.
  5. Dharkar-Surber S, Fortmann AL, Euyoque J, et al. Results of peer-led DM prevention program for high-risk Latino women with GDM. Poster presented at: the American Diabetes Association’s Scientific Sessions; June, 2012; Philadelphia, PA.
  6. Dharkar-Surber S, Euyoque J, Gallo LC, et al. Assessment of Dulce Mothers: A formative study in the risk reduction of diabetes after GDM. Poster presented at: the 33rd Annual Meeting of the Society of Behavioral Medicine; April, 2012; New Orleans, LA.

Diabetes is the seventh leading cause of death of U.S. adults and disproportionately affects certain diverse groups who are unfortunately underserved in traditional health care systems. That is why our team developed Project Dulce — a culturally-sensitive, peer-led diabetes self-management education program specifically adapted and designed to be relevant and reach Mexican American men and women treated for diabetes in federally qualified community health centers in San Diego County. This randomized controlled trial tested the effectiveness of Project Dulce versus usual care delivered to over 200 Mexican-American adults with type 2 diabetes. Results of this trial showed that Project Dulce significantly reduced blood glucose levels and other cardiometabolic outcomes that are so critical to the short- and long-term health for this important and often underserved diverse group. 


Principal Investigators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute)


Co-Investigators: N/A


Collaborators: Gregory Talavera, MD (San Diego State University), Linda C. Gallo, PhD (San Diego State University), Todd Gilmer (UC San Diego)


Community Partners: San Diego State University; Neighborhood Health Care; San Ysidro Health 



Related Publications and Presentations:

  1. Philis-Tsimikas A, Fortmann A, Lleva-Ocana L, Walker C, Gallo LC. Peer-Led diabetes education programs in high-risk Mexican Americans improve glycemic control compared with standard approaches: A Project Dulce promotora randomized trial. Dia Care. 2011;34(9):1926-1931. doi:10/cdpwgh
  2. Gilmer TP, Philis-Tsimikas A, Walker C. Outcomes of Project Dulce: A culturally specific diabetes management program. Ann Pharmacother. 2005;39(5):817-822. doi:10/fvfsjw
  3. Philis-Tsimikas A, Walker C, Rivard L, et al. Improvement in diabetes care of underinsured patients enrolled in Project Dulce: A community-based, culturally appropriate, nurse case management and peer education diabetes care model. Diabetes Care. 2004;27(1):110-115. doi:10/ddjqr4
  4. Philis-Tsimikas A, Gallo LC, Brewer AL, et al. Peer-led diabetes education programs in high-risk Mexican-Americans improve glycemic control compared to standard approaches: A Project Dulce promotora study. Poster presented at: the American Diabetes Association’s 69th Scientific Sessions; June, 2009; New Orleans, LA.

National multi-site trial to achieve optimal diabetes, hypertension and lipid control in high-risk individuals with type 2 diabetes and evaluate outcome on cardiovascular disease.


Principal Investigators: George Dailey, MD (Scripps Clinic Medical Group)


Co-Investigators: N/A


Collaborators: Athena Philis-Tsimikas, MD (Scripps Whittier Diabetes Institute)


Community Partners: N/A


  • Funder: NIH/NIDDK ACCORD Trial
  • Status: COMPLETED/2004-2015
  • ClinicalTrials.gov link: N/A

Commercially-sponsored clinical trials

Dr. Amy Chang. Endorincologist, Scripps Clinic, and a patient reviewing results.

Commercially-sponsored clinical trials

The Scripps Whittier Diabetes Institute partners with national and international pharmaceutical and device companies to conduct studies that offer opportunities for individuals with type 1 and type 2 diabetes, obesity, and non-alcoholic steatohepatitis that seek new devices and medications to improve their glucose management and to reduce the risk for associated diseases, such as retinopathy, cardiovascular disease and advanced non-alcoholic fatty liver infiltration. 


Examples of trials recently conducted in our center include: 


  • New once-weekly basal insulins alone and in combination with GLP1-receptor agonists (GLP1-RA), which provide better blood sugar control with less weight gain — remarkably, this means injection requirements can drop from 365 times a year to only 52 
  • Longer-term trials evaluating GLP1-RA (such as Ozempic, Rybelsus and Mounjaro) to treat diabetes and obesity and to prevent heart disease
  • Evaluating the efficacy and safety of advanced hybrid closed loop insulin pump systems for type 1 diabetes
  • An investigator-initiated study, in partnership with gastroenterologists at Scripps Clinic, using a fibroscan device to assess patients with type 2 diabetes for non-alcoholic fatty liver infiltration and fibrosis


To learn more about research studies at the N. Paul Whittier Clinical Diabetes Research Center and Scripps, view the active studies.


Our investigators have served as primary authors, presenters and partners in the conduct of many of these studies. Dr. Philis-Tsimikas’s publications.


  1. Philis-Tsimikas A, Asong M, Franek E, Jia T, Rosenstock J, Stachlewska K, Watada H, Kellerer M. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 Jun;11(6):414-425. doi: 10.1016/S2213-8587(23)00093-1. Epub 2023 May 3.
  2. Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C,Russell-Jones D, Rosenstock J, Rationale and design of the phase 3 development programme (ONWARDS 1–6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2022 Sept;doi.org/10.1111/dom.14871.13954. Epub 2022 Sept
  3. Miller KM, Kanapka LG, Rickels MR, et al. (Philis-Tsimikas A) Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):424-434. doi: 10.1089/dia.2021.0503. Epub 2022 Apr 11. PMID: 35294272; PMCID: PMC9208859.
  4. Carlson AL, Sherr JL, Shulman DI, et al. (Philis-Tsimikas A) Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Mar;24(3):178-189. doi: 10.1089/dia.2021.0319. Epub 2021 Nov 16. PMID: 34694909; PMCID: PMC8971997.
  5. Buse JB, Davies MJ, Frier BM, Philis-Tsimikas A. 100 years on: the impact of the discovery of insulin on clinical outcomes. BMJ Open Diabetes Research and Care 2021;9:e002373. doi: 10.1136/bmjdrc-2021-002373
  6. Martens T, Beck RW, Bailey R, et al. 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, for the 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;325(22):2262–2272.
  7. Philis-Tsimikas A, Lane W, Pedersen-Bjergaard U, Wysham C, Bardtrum L, Harring S, Heller S. The relationship between HbA1c and hypoglycaemia in patients with diabetes treated with insulin degludec versus insulin glargine 100 units/mL. Diabetes Obes Metab. 2020 May;22(5):779-787. doi: 10.1111/dom.13954. Epub 2020 Jan 24. PMID: 31903697; PMCID: PMC7186831.
  8. Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928. PMID: 32543682; PMCID: PMC7298607.
  9. Philis-Tsimikas A, Klonoff DC, Khunti K, Bajaj HS, Leiter LA, Hansen MV, Troelsen LN, Ladelund S, Heller S, Pieber TR; CONCLUDE Study Group. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. Diabetologia. 2020 Apr;63(4):698-710. doi: 10.1007/s00125-019-05080-9. Epub 2020 Jan 27. PMID: 31984443; PMCID: PMC7054369.
  10. Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4. PMID: 30761720
  11. Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4. PMID: 30949906
  12. Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N. Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study. J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5. PMID: 30600137
  13. Zinman B, Bhosekar V, Busch R, Holst I, Ludvik B, Thielke D, Thrasher J, Woo V, Philis-Tsimikas A. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 Mar 1. pii: S2213-8587(19)30066-X.. [Epub ahead of print] PMID: 30833170
  14. Philis-Tsimikas A, Billings LK, Busch R, Morales Portillo C, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior Efficacy of Insulin Degludec/Liraglutide versus Insulin Glargine U100 as Add-on to Sodium-Glucose Co-Transporter-2 Inhibitor Therapy: a Randomized Clinical Trial in Patients with Uncontrolled Type 2 Diabetes. Diabetes Obes Metab. 2019 Feb 13. [Epub ahead of print] PMID: 30761720
  15. Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Nørgård Troelsen L, Østoft SH, Philis-Tsimikas A, Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial. Clinical Diabetes 2019 Jan; 37(1): 73-81. PMID: 30705500
  16. Mathieu C, Bode BW, Franek E, Philis‐Tsimikas A, Rose L, Graungaard T, Birk Østerskov A, Russell‐Jones D. Efficacy and safety of fast‐acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52‐week, randomized, treat‐to‐target, phase III trial. Diabetes Obes Metab. 2018 May; 20(5): 1148–1155. Published online 2018 Feb 4. doi: 10.1111/dom.13205 PMCID: PMC5947306
  17. Lane W, Bailey TS, Gerety G, Gumprecht J; Philis-Tsimikas A; Hansen CT, Nielsen TSS, Mark Warren, Group Information; The SWITCH 1. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA. 2017 Jul 4;318(1):33-44, PMID: 28672316
  18. Aleppo G, Ruedy KJ, Riddlesworth TD, Kruger DF, Peter AL, Hirsch I, Bergenstal RM, Toschi E, Ahmann AJ, Shah VN, Rickels MR, Bode BW, Philis-Tsimikas A, Pop-Busui R, Rodriguez H, Eyth E, Bhargava A, Kollman C, Beck RW. REPLACE-BG: A randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in well-controlled adults with type 1 diabetes. Diabetes Care 2017 Apr; 40(4): 538-545
  19. Drab SR, Philis-Tsimikas A. A new option for glycemic control: insulin degludec, a new-generation basal insulin with an ultralong duration of action. Pharmacotherapy, 2014 Mar;34(3):291-302. doi: 10.1002/phar.1361. Review. PMID: 24132869
  20. Philis-Tsimikas A, Chang A, Miller L., Precision, accuracy, and user acceptance of the OneTouch SelectSimple blood glucose monitoring system. J Diabetes Sci Technol. 2011 Nov 1;5(6):1602-9. PMID: 22226284

Commercially-sponsored clinical trials

The Scripps Whittier Diabetes Institute partners with national and international pharmaceutical and device companies to conduct studies that offer opportunities for individuals with type 1 and type 2 diabetes, obesity, and non-alcoholic steatohepatitis that seek new devices and medications to improve their glucose management and to reduce the risk for associated diseases, such as retinopathy, cardiovascular disease and advanced non-alcoholic fatty liver infiltration. 


Examples of trials recently conducted in our center include: 


  • New once-weekly basal insulins alone and in combination with GLP1-receptor agonists (GLP1-RA), which provide better blood sugar control with less weight gain — remarkably, this means injection requirements can drop from 365 times a year to only 52 
  • Longer-term trials evaluating GLP1-RA (such as Ozempic, Rybelsus and Mounjaro) to treat diabetes and obesity and to prevent heart disease
  • Evaluating the efficacy and safety of advanced hybrid closed loop insulin pump systems for type 1 diabetes
  • An investigator-initiated study, in partnership with gastroenterologists at Scripps Clinic, using a fibroscan device to assess patients with type 2 diabetes for non-alcoholic fatty liver infiltration and fibrosis


Our investigators have served as primary authors, presenters and partners in the conduct of many of these studies.


  1. Philis-Tsimikas A, Asong M, Franek E, Jia T, Rosenstock J, Stachlewska K, Watada H, Kellerer M. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 Jun;11(6):414-425. doi: 10.1016/S2213-8587(23)00093-1. Epub 2023 May 3.
  2. Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C,Russell-Jones D, Rosenstock J, Rationale and design of the phase 3 development programme (ONWARDS 1–6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2022 Sept;doi.org/10.1111/dom.14871.13954. Epub 2022 Sept
  3. Miller KM, Kanapka LG, Rickels MR, et al. (Philis-Tsimikas A) Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):424-434. doi: 10.1089/dia.2021.0503. Epub 2022 Apr 11. PMID: 35294272; PMCID: PMC9208859.
  4. Carlson AL, Sherr JL, Shulman DI, et al. (Philis-Tsimikas A) Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Mar;24(3):178-189. doi: 10.1089/dia.2021.0319. Epub 2021 Nov 16. PMID: 34694909; PMCID: PMC8971997.
  5. Buse JB, Davies MJ, Frier BM, Philis-Tsimikas A. 100 years on: the impact of the discovery of insulin on clinical outcomes. BMJ Open Diabetes Research and Care 2021;9:e002373. doi: 10.1136/bmjdrc-2021-002373
  6. Martens T, Beck RW, Bailey R, et al. 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, for the 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;325(22):2262–2272.
  7. Philis-Tsimikas A, Lane W, Pedersen-Bjergaard U, Wysham C, Bardtrum L, Harring S, Heller S. The relationship between HbA1c and hypoglycaemia in patients with diabetes treated with insulin degludec versus insulin glargine 100 units/mL. Diabetes Obes Metab. 2020 May;22(5):779-787. doi: 10.1111/dom.13954. Epub 2020 Jan 24. PMID: 31903697; PMCID: PMC7186831.
  8. Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928. PMID: 32543682; PMCID: PMC7298607.
  9. Philis-Tsimikas A, Klonoff DC, Khunti K, Bajaj HS, Leiter LA, Hansen MV, Troelsen LN, Ladelund S, Heller S, Pieber TR; CONCLUDE Study Group. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. Diabetologia. 2020 Apr;63(4):698-710. doi: 10.1007/s00125-019-05080-9. Epub 2020 Jan 27. PMID: 31984443; PMCID: PMC7054369.
  10. Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4. PMID: 30761720
  11. Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4. PMID: 30949906
  12. Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N. Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study. J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5. PMID: 30600137
  13. Zinman B, Bhosekar V, Busch R, Holst I, Ludvik B, Thielke D, Thrasher J, Woo V, Philis-Tsimikas A. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 Mar 1. pii: S2213-8587(19)30066-X.. [Epub ahead of print] PMID: 30833170
  14. Philis-Tsimikas A, Billings LK, Busch R, Morales Portillo C, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior Efficacy of Insulin Degludec/Liraglutide versus Insulin Glargine U100 as Add-on to Sodium-Glucose Co-Transporter-2 Inhibitor Therapy: a Randomized Clinical Trial in Patients with Uncontrolled Type 2 Diabetes. Diabetes Obes Metab. 2019 Feb 13. [Epub ahead of print] PMID: 30761720
  15. Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Nørgård Troelsen L, Østoft SH, Philis-Tsimikas A, Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial. Clinical Diabetes 2019 Jan; 37(1): 73-81. PMID: 30705500
  16. Mathieu C, Bode BW, Franek E, Philis‐Tsimikas A, Rose L, Graungaard T, Birk Østerskov A, Russell‐Jones D. Efficacy and safety of fast‐acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52‐week, randomized, treat‐to‐target, phase III trial. Diabetes Obes Metab. 2018 May; 20(5): 1148–1155. Published online 2018 Feb 4. doi: 10.1111/dom.13205 PMCID: PMC5947306
  17. Lane W, Bailey TS, Gerety G, Gumprecht J; Philis-Tsimikas A; Hansen CT, Nielsen TSS, Mark Warren, Group Information; The SWITCH 1. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA. 2017 Jul 4;318(1):33-44, PMID: 28672316
  18. Aleppo G, Ruedy KJ, Riddlesworth TD, Kruger DF, Peter AL, Hirsch I, Bergenstal RM, Toschi E, Ahmann AJ, Shah VN, Rickels MR, Bode BW, Philis-Tsimikas A, Pop-Busui R, Rodriguez H, Eyth E, Bhargava A, Kollman C, Beck RW. REPLACE-BG: A randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in well-controlled adults with type 1 diabetes. Diabetes Care 2017 Apr; 40(4): 538-545
  19. Drab SR, Philis-Tsimikas A. A new option for glycemic control: insulin degludec, a new-generation basal insulin with an ultralong duration of action. Pharmacotherapy, 2014 Mar;34(3):291-302. doi: 10.1002/phar.1361. Review. PMID: 24132869
  20. Philis-Tsimikas A, Chang A, Miller L., Precision, accuracy, and user acceptance of the OneTouch SelectSimple blood glucose monitoring system. J Diabetes Sci Technol. 2011 Nov 1;5(6):1602-9. PMID: 22226284