Summer Research Update
On the research front, we have results to report from two completed trials, we are continuing to recruit for two occupational therapy trials, and we are completing a study with the Omnipod 5 hybrid closed-loop system in people with type 2 diabetes.
Occupational Therapy Trials
We are continuing to recruit for two trials on type 1 diabetes that have made a successful transition to remote visits. These are studies where we partner with a USC occupational therapy research team lead by Beth Pyatak, PhD.
Many of our patients with type 1 patients will qualify for the FEEL-T1D trial and this is a great introduction to clinical research. This is a two-week observational study for adults aged 18-75 with T1D where the purpose is to improve the understanding of the connection between blood glucose, well-being, and functioning to help improve future diabetes treatments.
If you participate in the trial, we will ship you a blinded continuous glucose monitor (you may also continue wearing your own CGM), accelerometer and a smart phone. Six times a day, participants will also be asked brief questions and perform visual tests on the study phone.
If you are interested contact: Mark Harmel, MPH, CDCES
We are also recruiting for a study of young adults with type 1 diabetes between the ages of 18-30 with an A1C of 7.5% or higher. This is a 12-month telehealth behavioral intervention that will be performed by USC occupational therapists to test a program designed to help young adults with type 1 diabetes deal with the everyday hassles and problems they experience in managing their diabetes.
All the meetings will take place online and an A1C test kit will be mailed. Participants will be compensated for these visits.
Half of the people in the study will be chosen at random to meet with an occupational therapist (OT) over 6 months using telehealth. What is an OT? Think of them like a diabetes coach, who helps young adults manage diabetes and deal with everyday hassles related to having diabetes. You will connect through videoconferencing to talk through your challenges and goals related to your diabetes care. The other participants will be followed over time to see how they do without the intervention.
OmniPod 5 in People With Type 2 Diabetes
We were excited to get our hands on the new Omnipod 5, the new tubeless hybrid closed-loop pump system that is expected to be available within the next 6 to 12 months. In this trial we used the pump in a set of patients with type 2 diabetes who were either using basal insulin alone or a mix of basal and mealtime insulin. We again have a mix of participants from the West and East Los Angeles and we have completed the initial three-month phase and have moved into a six-month extension with most of the participants. There are no results to share from the trial yet, but we have become experts in the use of the Omnipod 5 system which should help once it is approved by the FDA. The current projections are that it will be available through a limited launch in the last quarter of 2021 and more generally available in 2022.
MOBILE CGM Study in People with Type 2 Diabetes published in the Journal of the American Medical Association (JAMA)
This study was designed to determine if a Dexcom 6 CGM would provide benefits in either glucose control or quality of life for participants with type 2 diabetes who are using long-acting, but not mealtime insulin. This was a multicenter trial but our part of the study was performed at our East Los Angeles location which allowed us to recruit from a study population that is representative of many people with type 2 diabetes who often don't have access to the latest diabetes technology. The result after 8-months in the full study population was an A1c reduction from a starting 9.1% to 8% at the end in those who used CGM. The control group who used a blood glucose meter started at the same A1c of 9.1% and ended with an A1c of 8.4%. The difference was significant between the two groups.
Patients came from the offices of primary care providers and you may have noticed that the control group improved as well as those on the CGM. This because both groups benefited from diabetes and nutrition education, which they had never had before. The patients probably would have gotten even better, but Dr. Peters was not allowed to adjust the medication doses, just the patient’s primary care doctor. She gave them suggestions, but they were not always followed. This shows how important it is to teach primary care doctors about using continuous glucose monitors.
In the last newsletter we reported the results of a phase 2B trial of the new medication that targets the liver known as TTP399. In this 12-week study of participants with Type 1 diabetes the result was an A1C reduction of 0.7% with a 40% less hypoglycemia compared to placebo. The results were promising enough to continue to a larger phase 3 trial in the near future and we will let qualified participants know if we are selected as a trial site. In this study we also used the InPen in our participants who were using injection to monitor their mealtime dosing and proved to be a popular option and we are now prescribing this smart pen for our patients.