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

NCT04269655 | Terminated

• 1 other identifier: 19-7468
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes; Continuous Glucose Monitor; Blood Glucose; Cost-Effectiveness; Hospital; Diabetes Management; Technology; Remote Monitoring; Digital Dashboard; Cloud-Based; Hypoglycemia; Hyperglycemia; Real-Time; Clinical Decision-Making; Wireless Transmission

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Infection rates

  Through duration of index hospitalization, an average of 3 days

• Length of stay (LOS)

  Through duration of index hospitalization, an average of 3 days

• Cost of hospitalization

  Through duration of index hospitalization, an average of 3 days

• Hospital readmission rate

  30 days from the discharge date of the index hospitalization

Other Outcomes (1)

• CGM Satisfaction

  Through duration of hospitalization, an average of 3 days

Study Arms (2)

Intervention CB CGM

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Cloud-Based Continuous Glucose Monitoring DEVICE

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).

Intervention CB CGM

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Athena Philis-Tsimikas, MD

  Scripps Whittier Diabetes Institute

  PRINCIPAL INVESTIGATOR

• Addie Fortmann, PhD

  Scripps Whittier Diabetes Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a parallel groups, randomized controlled trial (RCT) utilizing a 4:1 (Intervention: UC) ratio. This design was selected to maximize the number of Scripps patients receiving the CB CGM intervention, while also ensuring an adequate and representative UC group for comparison purposes.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: February 25, 2020
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

US (1)