1006-P: Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital—The Cyber GEMS Randomized Controlled Trial Protocol

Introduction & Objective: Continuous glucose monitoring (CGM) for inpatient management of type 2 diabetes (T2D) has been supported by small pilot studies but lacks confirmation by large randomized controlled trials. The Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS) trial tests whether real-time CGM can improve time in, above, and below target glycemic range, and reduce hospital acquired infections.

Methods: This in-progress study is enrolling at 2 large disproportionate-share hospitals in Southern CA. Eligible patients are ≥18 years with T2D and on subcutaneous insulin with 3+ glucose ≥ 200 mg/dL. The CGM device is placed and validated against POCT using the %20/20 rule. The CGM transmitter sends data to a smartphone in a lock box at bedside that, in turn, transmits values to platforms for clinical management and evaluation purposes. Participants are randomized to usual care (UC) with point of care glucose testing (POCT) or Cyber GEMS with real-time CGM for glucose monitoring and management. In Cyber GEMS, CLARITY is used for clinical optimization by a remote diabetes RN specialist, the FOLLOW app on a unit iPad is used for real-time management by bedside RN, and a digital dashboard is used for real-time alert monitoring by a remote team. Blinded CGM is utilized in the UC group for outcome evaluation purposes only.

Results: N = 209 of 554 participants have completed the study. Participants are M = 61.3 ± 13.1 years of age, 59% male, 75% Hispanic; 58% reported an annual income < $20,000. Participants had an average maximum glucose of M: 315 ± 80.6 mg/dL prior to enrollment, an T2D duration of M = 17.3 ± 12.1 years; 92% were CGM naive. Average duration in the study was 3.7 days.

Conclusion: The Cyber GEMS protocol is uniquely designed to evaluate the value and utility of real-time CGM for optimizing hospital glucose management in a high-risk, underserved T2D population. Lessons learned and implications for hospital based CGM use will be presented.