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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Cloud-Based Continuous Glucose Monitoring

Detailed Description

This research study is designed to address these gaps by directly comparing the values of non-blinded, real-time and remotely monitored CGM data versus standard POC testing for hospital-based glucose management. Specifically, the investigators will investigate Cloud-Based Continuous Glucose Monitoring (CB CGM) versus standard POC testing (Usual Care; UC) in increasing % time-in-range (70-200 mg/dL), and in decreasing % time in hypoglycemia (<70 mg/dL) and severe hyperglycemia (>300 mg/dL) among N=300 adults with T2D. Patients will be enrolled at Scripps Mercy Hospital San Diego, Definitive Observation Unit (DOU) located in Hillcrest. This hospital serves predominantly low income, underinsured, ethnic/racial minority population in San Diego, California (CA). Participants will be randomized either to intervention or UC using a 4:1 ratio.

All participants will have a CGM inserted upon enrollment. For the UC group, CGM data will be blinded and used for evaluation only; glucose will be monitored via the hospital's standard point-of-care (POC) testing protocol. For the intervention group, CGM data will be non-blinded and transmitted to a HIPAA-compliant Digital Dashboard, which filters and prioritizes patients by clinical risk (algorithm-based) using real-time CGM data.

The Digital Dashboard will be monitored 24-hours/day by site-based telemetry teams for hyper- and hypoglycemic episodes that need rapid management per protocol. A centrally-located, Diabetes Advanced Practice Nurse (APN) will also remotely monitor glucose trends on the Digital Dashboard and recommend daily insulin adjustments to optimize the therapeutic regimen. Electronic medical records (EMR) will be used to identify eligible patients, and to compare exploratory outcomes (infection rate, LOS, healthcare costs, readmissions) between intervention and usual care.

Aim 1: To evaluate the effectiveness of CB CGM versus UC in increasing % time-in-range (70-200 mg/dL).

Aim 2: To evaluate the effectiveness of CB CGM versus UC in decreasing % time in hypoglycemia (<70 mg/dL) and severe hyperglycemia (>300 mg/dL).

Aim 3: To document the differences between CB CGM and UC in outcomes commonly affected by glycemic control in the hospital (infection rates, LOS, cost, 30-day hospital readmissions).

Process Aim: To evaluate feasibility, acceptability, sustainability, and scaling potential of CB CGM from patient, nursing, and physician perspectives.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Whittier Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 years of age
• English or Spanish speaker
• ≥ one of the following: diagnosis of type 2 diabetes documented in the EMR, or use of anti-hyperglycemic agent documented in the EMR, or serum or POC glucose > 200 mg/dL in the first 24 hours of admission

Exclusion Criteria:

• Anticipated LOS < 24 hours
• Current or anticipated ICU placement
• Does not speak English or Spanish
• Known adhesive allergy
• Current participation in medication or device study
• Pregnant
• Any other condition that the PI Dr. Philis-Tsimikas or the attending physician deem contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention CB CGM; On CB CGM patients, CGM data will also be transmitted from the bedside smartphone to the Digital Dashboard. The Digital Dashboard will integrate CGM data for CB CGM's participants for presentation via two views: (1) Real-Time Management and (2) Clinical Optimization. Telemetry technicians to conduct site-based monitoring, and the Diabetes APN will conduct remote management of patients at the site from a central, Scripps Diabetes Hub, per below. (Note, as CGMs are not FDA-approved for in-hospital glucose management, CB CGM participants will also have their glucose monitored via the hospital's standard POC testing protocol described for UC).	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).
No Intervention: Usual Care; For UC, CGM data will be blinded to the care team and used for evaluation purposes only. Glucose will be monitored via the hospital's standard POC testing protocol (i.e., prior to meals and at bedtime for patients who are eating, and every 4-6 waking hours for patients who are not eating). Glucose management in UC is designed to minimize differences between groups, aside from CGM monitoring: UC (and intervention) participants' glucose levels will be managed using the glucose management protocol and the Diabetes APN will assess UC participants' POC data documented in the EMR from the previous 24-48 hours and make recommendations for changes to the basal/bolus regimen to improve glucose management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage time-in-range of interstitial glucose values	Percentage time-in-range (70-200 mg/dL) of interstitial glucose values	Through duration of index hospitalization, an average of 3 days
Percentage time in hypoglycemia of interstitial glucose values	Percentage time in hypoglycemia (<70 mg/dL) of interstitial glucose values	Through duration of index hospitalization, an average of 3 days
Percentage time in severe hyperglycemia of interstitial glucose values	Percentage time in severe hyperglycemia (>300 mg/dL) of interstitial glucose values	Through duration of index hospitalization, an average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rates	Infection rates in hospital	Through duration of index hospitalization, an average of 3 days
Length of stay (LOS)	Length of stay in hospital	Through duration of index hospitalization, an average of 3 days
Cost of hospitalization	Healthcare costs associated with stay in hospital	Through duration of index hospitalization, an average of 3 days
Hospital readmission rate	Readmission to hospital within 30-days post-discharge	30 days from the discharge date of the index hospitalization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Satisfaction	Self-reported of Continuous Glucose Monitor Satisfaction	Through duration of hospitalization, an average of 3 days

Collaborators and Investigators

• Sponsor: Scripps Whittier Diabetes Institute
• Collaborators: DexCom, Inc.
• Investigators: Study Director: Addie Fortmann, PhD, Scripps Whittier Diabetes Institute; Principal Investigator: Athena Philis-Tsimikas, MD, Scripps Whittier Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Hypoglycemia; Diabetes Management; Hospital; Hyperglycemia; Blood Glucose; Remote Monitoring; Continuous Glucose Monitor; Technology; Cost-Effectiveness; Clinical Decision-Making; Digital Dashboard; Cloud-Based; Real-Time; Wireless Transmission
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 19-7468

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes