Young Adult Clinic

Young Adult Clinic Director:
Dr. Satish Garg, MD

The past few years have been filled with progress as the Young Adult Clinic continues to strive for excellence in diabetes care and research. The Young Adult Clinic provides care for approximately 3,000 patients ages 18-75. As we are growing, we extend our warm welcome to Dr. Ramachandra G. Naik, who joined the Clinic in December 2007. Dr. Naik received his endocrinology training from the premier institutes in India and United States, and brings with him over a decade of experience in clinical endocrinology practice in nationally top-ranked tertiary care private hospitals of Mumbai, India. We are very pleased to have him on board, and with his joining, the Young Adult Clinic is now open to accept new patients, particularly the subjects with type 1 diabetes. We are also anticipating the addition of another physician/endocrinologist to our staff later this year.
Diabetes education is extremely vital to the Young Adult Clinic, whether the patient is newly diagnosed or has had diabetes for over 50 years. As knowledge of type 1 diabetes expands and changes, it is our commitment that our patients share in that knowledge also. Each of our patients is seen by at least one educator before he or she sees the physician. We have found this approach to be of utmost importance as it allows the patient to voice concerns about hypoglycemia, medications or other issues, as well as learn about improved therapies for diabetes care.  On staff, we are pleased to provide access to clinical social workers, a pharmacist, nurses, as well as dieticians, who are Certified Diabetes Educators. These professionals educate our patients on how to effectively self manage their diabetes and to troubleshoot obstacles they may face in their health. Our clinic has seen tremendous success with its newly implemented educational classes featuring carbohydrate counting instruction, insulin pump training, and continuous glucose monitor training. We welcome our new nurse educator, Benita Lopez-Baca, who will be joining our team very soon; she has extensive experience of working previously at the Barbara Davis Center in the Pediatric Clinic. We are also fortunate to have Samuel Ellis, a pharmacist and a Certified Diabetes Educator in our team who is of immense help in our patient care activities especially for patients on multiple medications and drug interactions.
Dr. Satish K. Garg and his research staff have been busy with several clinical research studies which include investigating continuous glucose monitoring systems, newer insulins, and alternative modes of insulin administration. Conducting this research has not only allowed the clinic to be a part of bringing future treatments to real life, but it has also given our patients the opportunity be active research participants. By being a part of these clinical research trials at the Barbara Davis Center, we can be certain that we are offering our patients the most up-to-date education, information, and technology that is available in diabetic care.
Four Real Time Continuous Glucose Monitoring (RT-CGM) Systems are currently in use; they include Guardian RT® and Paradigm RT® (Medtronic MiniMed Inc.), DexCom Seven® (DexCom), and Free Style Navigator® (Abbott Diabetes Care). Each of these has their own advantages. For example, the Free Style Navigator, unlike the other CGM devices, gives interstitial glucose readings every minute for a total of 1,440 readings per day, and a unique feature of this device is that in addition to trend arrows it also provides patients with the actual rate of change and projected alerts. It also has a built-in glucose meter and has a higher accuracy in the hypoglycemic range. Dr. Garg and team are going to evaluate 10- and 14-days’ of sensor use with Free Style Navigator and a head-to-head comparison of Navigator and DexCom CGM systems in type 1 diabetes subjects in the coming months. Advancements of both clinical and internal CGM algorithms are necessary to further take advantage of this technology.  Changes to internal algorithms will be necessary to correct for sensor lag and over- and under- readings. Further research is also in progress assessing the closed-loop model incorporating insulin pump and CGM technology. 
Dr. Garg and his team have completed enrollment of a study sponsored by Biodel, in which VIAject, a faster acting form of human insulin is being tested for efficacy and safety in the Young Adult Clinic. This study is expected to continue until the insulin is approved in the following years by the FDA. VIAject is effectively regular human insulin with certain added ingredients allowing absorption in the body at a faster rate, thus allowing for the possibility of a cheaper alternative to the current market-leading insulin analogs.
Another Phase 3, multicenter, open-label, randomized clinical trial evaluating the efficacy and safety of Technosphere® Insulin (TI) Inhalational Powder (MannKind Corporation) in type 1 diabetes is commencing soon at our center. TI Inhalational Powder is a pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere® Inhalational Powder with an action profile similar to the physiological first phase insulin response. This study will be supervised by Dr. Naik.
In the past decade use on the continuous subcutaneous insulin infusion (CSII) has increased among diabetic patients. CSII therapy provides a constant insulin supply, thereby closely mimicking a normally functioning pancreas. The most common complications include blockage of the infusion set by the insulin, which can result in hyperglycemia. A new study compares the effectiveness of three different types of rapid acting insulin when used in CSII therapy. Insulin glulisine, aspart, and lispro are being evaluated on rate of occlusion of the infusion set and rates of unexplained hyperglycemia.
Additional alternative modes of continuous insulin delivery that do not need the catheters for insulin administration (“Insulin Patch Pumps”), are likely to be tested in the clinical trials in the future. (Examples include patch pump being developed by Novo Nordisk and V-Go). In collaboration with the Division of Endocrinology at the University of Colorado Hospital, Dr. Garg and Dr. Naik are expanding their research also in the area of therapy of type 2 diabetes in the coming months, with clinical trials soon commencing to test newer therapies including DPP-IV inhibitors.
Dr. Peter A. Gottlieb and his research staff are also working on some very exciting projects which include extensive work with new onset type 1 diabetes subjects. One of the research models supported by Dr. Gottlieb is the idea that new medications could suppress/modulate the immune system to potentially slow or alter the progression of type 1 diabetes. 
As the Director for ‘Type 1 Diabetes TrialNet’ at our Center, Dr. Gottlieb is working with his team on the effects of CTLA-4 Ig (Abatacept) on the progression of type 1 diabetes. This TrialNet sponsored trial is looking at the safety and efficacy of the medication CTLA-4 Ig and is being studied to determine if this medication modulates the immune system in an effort to potentially slow or alter the progression of Type 1 diabetes. This medication is given in the hospital about once every month for two years and the patients are then closely followed for an additional two years to see how CTLA-4 Ig affects their immune system and pancreas function.
TTEDD is a Phase 2 clinical study evaluating different multi-dose regimens of an anti-human CD3 monoclonal antibody (TRX4) therapy in type 1 diabetes to determine if it can slow the progression of the disease process by preserving residual beta cell function. Preserving your body’s ability to make its own insulin, by keeping the beta cells alive, may help relieve long-term complications and helps lessen the side effects of intensive insulin therapy, such as hypoglycemia. TTEDD is being conducted at the Barbara Davis Center by Dr. Peter Gottlieb, and is currently enrolling people who have been diagnosed with type 1 diabetes and are between 18 and 60 years of age.
The AbATE and Protégé trials are phase II and Phase III clinical trials, respectively, of a new drug called hOKT3γ (Ala-Ala), an anti-CD3 antibody, which has been shown in preliminary studies to slow the progression of type I diabetes in newly diagnosed patients. The AbATE and Protégé studies will test whether two short treatments of hOKT3γ (Ala-Ala) can halt any further loss of beta cells by establishing a state of immune "tolerance" towards the beta cells. The AbATE trial administers treatment at the beginning of the trial and again after twelve months, while the Protégé trial administers treatment at the beginning of the trial and again after six months. A preliminary study showed that hOKT3γ (Ala-Ala) given to newly diagnosed type 1 diabetes could preserve beta cell function and decreases the insulin dose required compared to patients receiving standard diabetes management. The effects of the drug lasted for at least two years. The AbATE trial study is currently enrolling people who are between 8 and 30 years of age and who have been diagnosed with type 1 diabetes within the past 6 weeks.  The Protégé trial study is currently enrolling people who are between 18 and 35 years of age and who have been diagnosed with type 1 diabetes within the past 12 weeks. 
Another, ‘Immune Tolerance Network’-sponsored, early phase II study of the safety and efficacy of the rabbit polyclonal anti-thymocyte globulin (ATG), in new onset type 1 diabetes mellitus to determine if this treatment can induce tolerance and thereby prolongs endogenous insulin secretion in affected individuals is being conducted by Dr. Gottlieb’s team. ATG is administered four times over five days in the hospital. The patients are then closely followed for at least two years, with the potential to be followed for up to five years to see how the medication affects the immune system and the pancreatic function.
Working with Bayhill Therapeutics, Inc. Dr. Gottlieb is also investigating the safety of an experimental agent BHT-3021. In this Phase I randomized, double-blind, dose-escalation study, injections of BHT-3021 are administered weekly for 12 weeks to evaluate the safety of the product and the effect of BHT-3021 on antibody and immune responses to autoantigens (e.g., insulin). This is the first clinical research study of BHT-3021 in humans. BHT-3021 is designed to decrease abnormal immunity to insulin, and it is also thought that BHT-3021 may decrease damage to the insulin-producing cells in the pancreas. The study is currently enrolling type 1 diabetes subjects 18 years and older.
By stopping or delaying the autoimmune process, it is hoped that participants would continue to produce endogenous insulin from their beta cells. Production of insulin allows patients to have better control of their blood glucose levels, and consequently lesser chances of developing long term complications.
To conclude, we have had very exciting few years at the Young Adult Clinic of the Barbara Davis Center and we do look forward to continuing to provide excellent care to our adults with type 1 diabetes. With a well-trained and efficient staff, intensive patient education, and clinical research, it is our hope that diabetes is a disease which anyone can successfully manage.