Creating Linked Inpatient CGM for Kids
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-24
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Pediatric diabetic Dexcom G7 users
Trial outcomes
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.
Time frame
The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.Secondary outcomes
1
Efficiency of CGM data capture.
Efficiency of CGM data capture, measured as the percent of CGM readings documented in Dexcom Clarity that were also captured by the companion app within the same 5-minute interval.
Time frame
The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.Sponsors and contacts
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Source ClinicalTrials.gov
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