Research Studies

Mi Diario

This project will investigate the feasibility and acceptability of developing a new mHealth app to support the management of T1D in Latino adolescents. The objective of this study is to help Latino teens manage their T1D by offering strengths-based, culturally sensitive tools to build knowledge and facilitate self-efficacy and planning. 

When: Beginning in December of 2023.

We are looking for: 

• 30 Latino adolescents (12-20 yrs) with Type 1 diabetes seen at the BDC.
• Caregivers that usually or always measures or administers insulin.

Inclusion:

• Patients seen at the BDC, with a diagnosis of Type 1 diabetes, and their caregivers.
• Patient aged 12-20 years at time of recruitment
• Latino/Hispanic
• Spanish-speaking and/or bilingual parent(s) or caregiver(s)
• Have access to and can operate a smart phone or tablet
• Family willingness to participate in a clinical study and attend visits at a study site.

Exclusion:

• Patients seen at BDC with other than Type 1 diabetes diagnosis (e.g. MODY, Type 2, Medication induced diabetes, genetic forms of diabetes)
• Patients without access and/or ability to use the technology needed to access the app.
• Significant developmental or cognitive disorder in patient.
• Significant mental illness in parent/guardian that would interfere with ability to give consent or participate.
• Failure to understand study requirements.

Compensation:

$30/ hr

Funding Source: The National Institutes of Health (NIH) & Centers for Disease Control and Prevention (CDC) Innovation Research Program

If you are interested in participating in this study, please contact the research coordinator Erika Rodríguez via epic message, email (erika.rodriguez@cuanschutz.edu) or phone 303-724-6758.

TrialNet: Early Detection of Type 1 Diabetes

The Barbara Davis Center has been active in designing and conducting type 1 diabetes (T1D) studies aiming to prevent type 1 diabetes and extend insulin production (the honeymoon) in people with newly diagnosed type 1 diabetes for over 25 years. The BDC is the Colorado home for the Type 1 Diabetes TrialNet and the BDC Type 1 Diabetes Prevention Teams.

Screening for Type 1 Diabetes

As part of the TrialNet Pathway to Prevention Study, the BDC offers free screening to detect risk for T1D by measuring type 1 diabetes-related islet autoantibodies in relatives of people with T1D (trialnet.org) under age 45 years. Screening is offered at the BDC or remotely through a home finger poke kit or commercial lab (Quest/LabCorp) kit.

Signing up for screening for T1D risk is easy, and we have several options to provide more information, schedule a screening appointment or send you a home or laboratory screening kit:

Call (720) 346-1034 or e-mail hali.broncucia@cuanschutz.edu

Sign up for screening online at: trialnet.org/participate. Please indicate Barbara Davis Center in the online form.

TrialNet: Preservation of Insulin Producing Beta-Cells

The Barbara Davis Center (BDC) has been active in designing and conducting type 1 diabetes (T1D) studies aiming to prevent type 1 diabetes and extend insulin production (the honeymoon) in people with newly diagnosed type 1 diabetes for over 25 years. The BDC is the Colorado home for the Type 1 Diabetes TrialNet and the BDC Type 1 Diabetes Prevention Teams.

Type 1 Diabetes Prevention and Intervention

Youth and adults who screen positive for type 1 diabetes-related islet autoantibodies through TrialNet are offered free metabolic monitoring for progression to T1D and can participate in T1D clinical prevention trials. People who do not have a family history of T1D but have documented type 1 diabetes-related islet autoantibodies from another lab or study are able to confirm their antibody status by screening in the TrialNet Pathway to Prevention Study in order to have access to T1D prevention clinical trials.

The Prevention Team at the BDC has been at the forefront of performing clinical trials to delay progression to T1D and to arrest the disease process in newly diagnosed T1D patients. We are proud to have been a critical part of the TrialNet study that led to the first FDA approved therapy to delay T1D onset, Tzield. We have ongoing clinical trials testing therapies to delay and prevent the onset of T1D. We also offer a variety of studies with novel therapies to preserve the health of surviving insulin producing b-cells and to therefore prolong the honeymoon phase. We have new studies opening every few months. If you have been diagnosed in the past two years and are interested in learning more about our current clinical trials, please contact the BDC Prevention Team at 720-346-1034 or hali.broncucia@cuanschutz.edu or visit https://www.trialnet.org or https://clinicaltrials.gov.

Principal investigator: Andrea Steck, MD

Study coordinator: Hali Broncucia (303) 724-7526

The Barbara Davis Center has been active in designing and conducting type 1 diabetes studies aiming to prevent type 1 diabetes and extend insulin production (the honeymoon) in people with newly diagnosed type 1 diabetes for over 25 years. The BDC is the Colorado home for the Type 1 Diabetes TrialNet and the BDC Type 1 Diabetes Prevention Teams.

Type 1 Diabetes Prevention and Intervention

Youth and adults who screen positive for type 1 diabetes-related islet autoantibodies through TrialNet are offered free metabolic monitoring for progression to T1D and can participate in T1D clinical prevention trials. People who do not have a family history of T1D but have documented type 1 diabetes-related islet autoantibodies from another lab or study are able to confirm their antibody status by screening in the TrialNet Pathway to Prevention Study in order to have access to T1D prevention clinical trials.

The Prevention Team at the BDC has been at the forefront of performing clinical trials to delay progression to T1D and to arrest the disease process in newly diagnosed T1D patients. We are proud to have been a critical part of the TrialNet study that led to the first FDA approved therapy to delay T1D onset, Tzield. We have ongoing clinical trials testing therapies to delay and prevent the onset of T1D. We also offer a variety of studies with novel therapies to preserve the health of surviving insulin producing b-cells and to therefore prolong the honeymoon phase. We have new studies opening every few months. If you have been diagnosed in the past two years and are interested in learning more about our current clinical trials, please contact the BDC Prevention Team at 720-346-1034 or hali.broncucia@cuanschutz.edu or visit https://www.trialnet.org or https://clinicaltrials.gov.

For nearly 40 years, patients have used blood glucose meters for self-monitoring of blood glucose (SMBG), a cornerstone of diabetes management. The Barbara Davis Center (BDC) adult clinic has conducted extensive research on various meters, including high-altitude evaluations (~10,000 feet) required by the FDA for device approval. Recent studies have focused on smartphone-connected devices like the iBG Star (Sanofi) and the Dario meter. While continuous glucose monitors (CGMs) are gaining popularity, SMBG remains essential, especially given the high cost and limited insurance coverage of CGMs.

Continuous glucose monitoring has revolutionized diabetes care by providing real-time glucose readings every five minutes, allowing patients to track trends and patterns. Research at the BDC began over 20 years ago with the GlucoWatch, which received FDA approval in 2001. Since then, the BDC has evaluated numerous CGMs, including implantable options, Abbott Navigator, Medtronic Enlite Sensor, and the Dexcom STS, G4, and G5 sensors. More recently, the center contributed to FDA approvals for the Dexcom G6 and Medtronic Guardian sensors. Current studies focus on newer technologies like the Medtronic Zues sensor, Dexcom G7, and the Eversense 180-day implantable CGM. Accuracy has significantly improved, with modern sensors achieving a mean absolute relative difference (MARD) under 10%, compared to the 20% MARD of the GlucoWatch.

The BDC has been instrumental in advancing insulin pump technology. Over the past decade, studies at the center have supported the development and FDA approval of the Medtronic 670G, the first hybrid closed-loop (HCL) insulin pump, in 2016. Earlier breakthroughs included the Medtronic 530G, featuring Threshold Suspend technology, which was approved in 2013. Current research involves next-generation HCL systems, including pumps from Omnipod, Tandem, and Dexcom CGM-integrated systems.

Insulin remains the cornerstone of type 1 diabetes treatment. The BDC has contributed to the development of rapid-acting insulins like Humalog, Novolog, and Apidra, as well as long-acting options such as Lantus U-100. Recent studies have focused on ultra-long-acting insulins like Toujeo and Tresiba and faster-absorbing formulations using additives such as Halozyme. Current research includes ultra-rapid-acting Lispro for use in multiple daily injections (MDI) and pumps.

The BDC has also explored alternative insulin delivery methods, including buccal and inhaled options. While many inhaled insulins have been discontinued, Afrezza by MannKind remains on the market and has been evaluated at the center.

The BDC has investigated medications that complement insulin therapy in managing blood sugar. SGLT inhibitors like dapagliflozin and sotagliflozin have shown promise for improving glucose control without weight gain. These medications are approved for type 1 diabetes in Europe and Japan but await FDA approval in the U.S.

Achieving strict glucose targets during pregnancy is critical for maternal and fetal health. The BDC has conducted studies on the safety and effectiveness of CGMs during pregnancy and is currently comparing hybrid closed-loop therapy to sensor-augmented pump therapy during the second and third trimesters. This research aims to optimize outcomes for pregnant individuals with type 1 diabetes.