Scripps Digital Diabetes: Cloud-Based Continuous Glucose Monitoring (CB CGM)

Summary

Individuals with diabetes in the hospital often experience poor glycemic control, which places them at greater risk for infection, neurological and cardiac complications, mortality, longer lengths of stay, readmissions, and higher healthcare costs. There are few effective interventions for monitoring hospital glucose management therefore the long-term goal of developing Cloud-Based Real-Time Glucose Evaluation and Management System is to provide an effective, real-time continuous glucose monitoring solution necessary for clinical decision-making which can be easily managed for clinical risk 24 hrs/day. The innovative intervention will enable hospital care teams to take immediate steps based on wireless transmission of glucose data from the Dexcom G6 device, sent to a Digital Dashboard, where integration with existing real-world hospital processes can provide immediate prioritization to prevent or correct impending hypoglycemia and severe hyperglycemic events. This randomized controlled trial is defined as a Phase III/IV definitive clinical trial to establish efficacy and effectiveness of this intervention. Aim 1 will assess mean differences of % time in range between intervention and Usual Care groups to find occurrence of glucose levels that are in range at 70-200mg/dL. Aim 2 will apply the same method, using % time above range of \>300mg/dL (severe hyperglycemia) and % time below range \<70mg/dL (hypoglycemia). Poor glycemic control in the hospital is common and given the known consequences of uncontrolled blood sugars during a hospitalization, health systems devote significant resources to developing protocols for improving glucometrics. The likely impact of this innovative research is to have an efficient, and seamless alternative for continually monitoring glucose levels in the hospital. The Digital Dashboard facilitates real-time, remote monitoring of a large volume of patients simultaneously; automatically identifies and prioritizes patients for intervention; and will detect any and all potentially dangerous hypoglycemic episodes. The work proposed pushes the limits of these challenges by providing evidence, identified by a team-based approach to glucose management in an underserved and understudied population supplementing prior data designed to improve outcomes among high-risk patients with type 2 diabetes (T2D) and related cardio metabolic conditions. The proposed intervention is flexible, sustainable, and has high dissemination potential.

Conditions

• Diabetes Mellitus, Type 2

Interventions

DEVICE

Cloud-Based Continuous Glucose Monitoring

The CGM data will be transmitted via bluetooth to a smartphone. The smartphone will automatically transmit values to a secure cloud-based platform, which then populates to the: (1) web-based, CGM data management tool for evaluation purposes (both groups), and (2) Digital Dashboard for monitoring and intervention (intervention only).

Sponsors & Collaborators

• DexCom, Inc.

  collaborator INDUSTRY

• Scripps Whittier Diabetes Institute

  lead OTHER

Principal Investigators

• Athena Philis-Tsimikas, MD · Scripps Whittier Diabetes Institute

• Addie Fortmann, PhD · Scripps Whittier Diabetes Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-25

Primary Completion

2020-03-17

Completion

2020-03-17

Countries

• United States

Study Locations