Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital (Cyber GEMS)

NCT05307237 | Completed DMC

• 1 other identifier: R01DK124427
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

Brief Summary

Given the known serious consequences of uncontrolled blood sugars during hospitalization, this research plans to study an alternative seamlessly integrated continuous glucose monitoring (CGM) system in the hospital to test a dynamic and digitized, team-based approach to glucose management in an underserved and understudied, yet high-risk population. A digital dashboard will facilitate real-time, remote monitoring of a large volume of patients simultaneously; automatically identify and prioritize patients for intervention; and will detect any and all potentially dangerous hypoglycemic episodes in a hospital environment. The study will focus on clinical metrics of glucose control and infection that are in-line with patient priorities and US hospital quality initiatives.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Hospital; Continous Glucose Monitoring

Outcome Measures

Primary Outcomes (3)

• Percent time in range

  Participants will have their percent time in range calculated following a minimum CGM data collection period of 12 hours and expressed as a percentage where: Percent Time in Range= 100 (Number readings in range (70-200mg/dL)/Total number of readings from CGM). Number of readings will be used in calculation, which scale directly with time.

  Immediately following intervention completion

• Percent time spent in hypoglycemia and percent time in severe hyperglycemia

  Our second outcome will be assessed by the same methods as the first, but instead looking at Percent Time in Severe Hyperglycemic Range (\>300mg/dL) and Percent Time in Hypoglycemic Range (\<70mg/dL).

  Immediately following intervention completion

• Infection Rate

  Rates of hospital-acquired infection are defined as skin wound or surgical site, central line-associated bloodstream infection, urinary tract infection, bacteremia, clostridium difficile infection, or pneumonia not present at admission. Unadjusted incidence rates among study participants will be compared between intervention and control groups via Chi-Square test of two proportions.

  Immediately following intervention completion

Secondary Outcomes (3)

• Glucose Variability

  Immediately following intervention completion

• Electronic Medical Record (EMR) - Derived Outcomes: HbA1C

  Immediately following intervention completion

• Electronic Medical Record (EMR) - Derived Outcome: fasting POC blood glucose

  Immediately following intervention completion

Other Outcomes (12)

• Process Indicators (Reach): Enrollment Characteristics

  Immediately following intervention completion

• Process Indicators (Reach): Representative Characteristics

  Immediately following intervention completion

• Process Indicators (Reach): CGM wear time

  Immediately following intervention completion

Study Arms (2)

Continuous Glucose Monitoring

EXPERIMENTAL

Research Assistants (RAs) will verbally administer baseline survey and insert Dexcom G6 CGM, before unveiling the group assignment. CGM data will be transmitted from bedside iPhone to web-based platforms for: (1) Real-Time Management (via iPad-based FOLLOW app used by bedside RN and Digital Dashboard used by remote monitoring team) and (2) Clinical Optimization (via CLARITY, a Diabetes RN Coordinator will conduct remote clinical management of patients from a central, Scripps Diabetes Hub). A post-CGM satisfaction survey will be administered and compensation provided when CGM is removed prior to discharge or within 2 weeks following discharge. The CGM readings will be used to make recommendations for insulin adjustment and glucose management. After discharge, CGM data will be downloaded from a HIPPA-compliant, web-based CGM data management tool, and saved in Excel. The Data Analyst, blinded to condition, will routinely screen CGM data and merge individual spreadsheets for analysis.

Device: Dexcom G6 Continous Glucose Monitoring Management

Usual Care

ACTIVE COMPARATOR

RAs will verbally administer a baseline survey and insert the Dexcom G6 CGM. before unveiling the group assignment. CGM data will be blinded 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 if not eating). Glucose management in UC is designed to minimize differences between groups, aside from CGM monitoring, A post-CGM satisfaction survey will be administered and compensation provided when the CGM is removed prior to discharge or within 2 weeks following discharge. After discharge, CGM data will be downloaded from a HIPPA-compliant, web-based CGM data management tool, and saved in individual Excel spreadsheets. The study Data Analyst, blinded to study condition, will routinely screen CGM data and merge individual spreadsheets for analysis.

Device: Usual Care - Blinded Continuous Glucose Monitoring Management

Interventions

Usual Care - Blinded Continuous Glucose Monitoring Management DEVICE

CGM data will be blinded 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 if not eating). Glucose management in UC is designed to minimize differences between groups, aside from CGM monitoring.

Usual Care

Dexcom G6 Continous Glucose Monitoring Management DEVICE

CGM data will be transmitted from the bedside iPhone to web-based platforms for: (1) Real-Time Management (via iPad-based FOLLOW app used by bedside RN and Digital Dashboard used by the remote monitoring team) and (2) Clinical Optimization (via CLARITY, by which a Diabetes RN Coordinator will conduct remote clinical management of patients from a central, Scripps Diabetes Hub.

Continuous Glucose Monitoring

Eligibility Criteria

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

You may qualify if:

• Documented previous or current Type 2 Diabetes (T2D) diagnosis as defined by either diagnosis in the chart or an HbA1c \> or = to 6.5% in the last 90 days
• Either on subcutaneous (SQ) insulin orders, or greater than two serum or Point of Care (POC) glucose \> or = 200 mg/dL in most recent 24 hours of admission

You may not qualify if:

• Anticipated length of stay \< 24 hours;
• Current or anticipated ICU placement;
• Does not speak English or Spanish;
• Known allergy to adhesives;
• Current participation in any medication or device research study;
• Pregnant;
• Any other condition that Multiple Principal Investigator (MPI) Philis-Tsimikas or the attending physician deems contraindicated

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Scripps Mercy Hospital

Chula Vista, California, 91910, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

  PRINCIPAL INVESTIGATOR

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: Corporate Vice President

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: April 1, 2022
• Study Start: April 19, 2022
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)