Satish K. Garg, United States of America
Barbara Davis Center for Childhood Diabetes EndocrinologyPresenter of 5 Presentations
Managing T1D-new-onsets and DKA through telehealth
Abstract
Abstract Body
Since December of 2019, the COVID-19 outbreak has affected more than 215 countries, translating to more than 125 million cases worldwide of COVID-19 at the time of this writing. More than 2.8 million people have died from COVID-19 across the globe; specifically, in the USA and South America, there have been more than 30 million cases reported, with a total of 560,000 deaths due to the virus. The exact prevalence of infection is currently unknown. However, it is commonly believed that ~70-80% of the population will need to be infected or vaccinated for herd immunity to be effective.
Many new-onset patients with type 1 diabetes delayed seeking medical advice during COVID-19 because of the risk of getting infected. Many hospitals noted a higher number of patients presenting with diabetic ketoacidosis because of the delay in diagnosing type 1 diabetes. Similar concerns were noted by many of the physicians managing diabetes during pregnancy. However, in many instances, most diabetes care including patients with DKA could be effectively managed remotely by using newer technologies like CGM, insulin pumps, and hybrid closed-loop systems. In several instances, even the pump and CGM initiation were initiated remotely with no adverse outcomes. The virtual care gave a similar or better Time in Range (TIR) for glucose levels with no increase in Time Below Range during the virtual care period, irrespective of how patients were treated (whether it was remotely or in-person).
COVID-19 Pandemic and Virtual Clinics for Diabetes Care
NAFLD and NASH and Diabetes
Introduction
THE PROMISE STUDY: AN EVALUATION OF THE SAFETY AND ACCURACY OF THE NEXT GENERATION 180-DAY LONG-TERM IMPLANTABLE EVERSENSE CGM SYSTEM
- Satish K. Garg, United States of America
- David Liljenquist, United States of America
- Bruce W. Bode, United States of America
- Mark Christiansen, United States of America
- Timothy Bailey, United States of America
- Ron Brazg, United States of America
- Douglas Denham, United States of America
- Anna Chang, United States of America
- Halis K. Akturk, United States of America
- Andrew Dehennis, United States of America
- Katherine S. Tweden, United States of America
- Francine R. Kaufman, United States of America
Abstract
Background and Aims
The prospective, multi-center PROMISE Study was conducted from 27Dec2018-08May2020 in 181 adults ≥18 years with diabetes at 8 US clinical sites to evaluate the safety and accuracy of the next generation Eversense CGM System for up to 180 days.
Methods
During 10 clinic visits between day 1-180 lasting up to 10 hours, accuracy between 40-400mg/dL was assessed comparing CGM and reference glucose values from Yellow Springs Instruments (YSI), including hyperglycemia and hypoglycemia challenges. A total of 279 sensors were placed (85 and 96 subjects had 1 and 2 sensors inserted in the arm, respectively, with 2 replaced sensors) for 558 insertion/removal procedures. Two calibrations/day to day 21 were prompted, after which it primarily prompts 1 calibration/day.
Results
The mean age was 48.6 years (range 18-77years). Accuracy analyses were based on 49,613 matched pairs over 180 days. Percent CGM readings within 15/15% and 20/20% of YSI values was 85.6% and 92.9%, respectively, and the overall Mean Absolute Relative Difference (MARD) was 9.1%. MARDs across different time periods over 180 days were <9.6% (Table), except for the beginning and end of sensor life. The confirmed hypoglycemia detection rate at 70mg/dL and 60mg/dL were 93% and 87%, respectively. Hyperglycemia at 180mg/dL was detected in 99%. There were no device or insertion/removal procedure-related serious adverse events. Two mild skin infections occurred for a rate of 0.36% per procedure.
Conclusions
These results indicate the next generation Eversense long-term implantable CGM System has sustained accuracy and safety up to 180 days with mainly one calibration/day.