Creating Linked Inpatient CGM for Kids

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06899503
Status
Not Yet Recruiting

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Conditions

  • Continuous Glucose Monitoring System
  • Diabetes

Eligibility Criteria

Sex
ALL
Age
2 Weeks - 24 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 31, 2027
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Pediatric diabetic Dexcom G7 users
    Diabetic pediatric patients using their personal Dexcom G7 admitted for clinical care purposes.

Primary Outcome Measure

Accuracy of CGM data capture. [ Time Frame: The earlier of a maximum of 20 days or 72 hours following the first sensor exchange. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Jessica L Ruiz, MD
[email protected]
617-355-7241
Michael SD Agus, MD
[email protected]
617-355-5849

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