Creating Linked Inpatient CGM for Kids

NCT06899503 | Not Yet Recruiting

• 1 other identifier: IRB-P00049941
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous glucose monitors (CGMs) are currently used in the inpatient setting at many hospitals for the care of patients with diabetes and for clinical research studies. This includes Boston Children's Hospital, however, the CGM data is not accessible to clinical or research teams in real-time. CGMs measure and display a patient's glucose level every 5 minutes and provide alerts for predicted or actual low or high glucose levels. The CGM data is currently only accessible on bedside handheld receivers or a mobile device app, neither of which sync with the hospital EMR or other hospital databases. This observational study tests a companion mobile Android device app that wirelessly receives real-time outputs from the Dexcom G7 CGM app and transmits the data to a centralized hospital database. That database in turn feeds into an internal BCH web dashboard which allows live data viewing and integration into future clinical decision support tools. The investigators are testing the hypothesis that the companion mobile app can accurately and efficiently transmit CGM data to a hospital database. Data will be analyzed for accuracy and efficiency by comparing CGM readings captured by the companion app to CGM readings documented in the formal Dexcom database. Accuracy (difference between CGM readings from both sources) and efficiency (number of CGM readings captured) will be assessed. The findings will be generalizable to using the companion app in future research studies.

Conditions

Diabetes; Continuous Glucose Monitoring System

Keywords

Diabetes; Continuous glucose monitoring system; Android application

Outcome Measures

Primary Outcomes (1)

• Accuracy of CGM data capture.

  The accuracy of the CGM readings captured will be measured as the mean absolute relative difference (MARD) between the CGM glucose reading captured by the companion app compared to the CGM glucose reading documented in the Dexcom Clarity database within the same 5-minute interval.

  The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.

Secondary Outcomes (1)

• Efficiency of CGM data capture.

  The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.

Study Arms (1)

Pediatric diabetic Dexcom G7 users

Diabetic pediatric patients using their personal Dexcom G7 admitted for clinical care purposes.

Eligibility Criteria

• Age: 2 Weeks - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients at Boston Children's Hospital (BCH) with diabetes, admitted for clinical care purposes, using their personal Dexcom G7 CGM during the inpatient admission.

You may qualify if:

• Inpatients with diabetes using a Dexcom G7 CGM
• Technology/data sharing criteria: use of the Dexcom G7 phone app and data sharing with the BCH Dexcom Clarity Database
• Anticipated discharge date \>24 hours after study eligibility

You may not qualify if:

• Use of medications that interfere with CGM accuracy
• Use of a Dexcom receiver to view data (rather than the typical mobile phone)
• Enrollment in a competing clinical trial

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jessica L Ruiz, MD

CONTACT

617-355-7241; Jessica.Ruiz@childrens.harvard.edu

Michael SD Agus, MD

CONTACT

617-355-5849; Michael.Agus@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Endocrinology

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)