Glycemic Optimization On Discharge From the Emergency Room

NCT05197829 | Completed Results FDA Device

• 1 other identifier: H00023559
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous glucose monitors can help people with diabetes avoid blood sugar levels that are either dangerously high or low. This study evaluates whether continuous glucose monitoring after discharge from the emergency room can help people with type 1 or type 2 diabetes avoid repeat emergency room visits, achieve improved blood sugar control, and feel less distressed about managing their diabetes.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change in Diabetes Distress

  Diabetes-related distress will be measured via the 17-question Diabetes Distress Scale (DDS). A higher score indicates more diabetes-related distress. The scale ranges from 1 (low distress) to 6 (high distress).

  Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

• Outpatient Clinic Attendance Rate

  This outcome will measure whether or not each participant attends a subspecialty follow-up appointment as recommended by the emergency room care team.

  Follow-up visits will generally occur within 2 or 3 weeks

• Change in the Problem Areas in Diabetes Score

  Each participant will fill out the five-question Problem Areas In Diabetes (PAID5) scale. A higher score indicates worse quality of life. Scores range from 0 (good quality of life) to 20 (poor quality of life).

  Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)

Secondary Outcomes (6)

• Number of Patients With Repeat Emergency Utilization

  6 months

• Change in Hemoglobin A1c

  6 Months

• Outpatient Visits for Which the CGM Data Changed Management

  2-3 Weeks

• Time In Range

  Up to 14 days after the initial emergency visit

• Percentage Time CGM Active

  Up to 14 days after the initial emergency visit

Study Arms (2)

Continuous Glucose Monitoring

EXPERIMENTAL

Device: Continuous Glucose Monitoring; Other: Care Coordination

Care Coordination

ACTIVE COMPARATOR

Other: Care Coordination

Interventions

Continuous Glucose Monitoring DEVICE

Participants in the experimental arm will receive an unblinded flash continuous glucose monitor.

Continuous Glucose Monitoring

Care Coordination OTHER

All participants will receive diabetes education, written handouts, and help setting up ambulatory appointments.

Care Coordination; Continuous Glucose Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Seen in the Emergency Department for hypo- or hyperglycemia
• Either an existing diabetes center patient or a new referral
• Type 1 or type 2 diabetes
• Able to provide informed consent
• Fluent in English or Spanish

You may not qualify if:

• Current CGM use
• Need for hospital admission
• Upcoming CT or MRI within 2 weeks
• Pregnancy
• Altered mental status
• Not appropriate for diabetes center follow up
• Prisoners

Sponsors & Collaborators

• Mark O'Connor: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Mark O'Connor
• Organization: University of Massachusetts Chan Medical School

mark.oconnor2@umassmed.edu

508-334-1000

Study Officials

• Mark J O'Connor, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 20, 2022
• Study Start: January 5, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2024
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)