Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2025-04-30
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
NCT05505565
Continuous Glucose Monitors for Children With Diabetes Mellitus
NCT00069537
Assessing Continuous Glucose Monitors in Healthy Children
NCT00069602
Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia
NCT02300285
Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
NCT03020069
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Currently, CGM data is not accessible to clinical or research teams in real-time. The CGM data is currently only accessible on bedside handheld receivers or a cell phone app, neither of which syncs with the hospital EMR or other hospital databases. The current clinical workflow requires the bedside caregiver to alert the clinical team of any glucose abnormalities. In order to view and document CGM glucose levels in real-time, clinical and research teams must be physically at the bedside viewing the CGM receiver or the patient's personal cell phone app screen. Teams do have access to the Dexcom Clarity database, an online cloud-based data viewing dashboard, but data transmission is delayed 3 hours from the Dexcom cloud database to Dexcom Clarity.
This observational study tests a companion mobile Android application that receives real-time data from the Dexcom G7 CGM app running on a hospital provided mobile device. The companion app and G7 app modifications were developed from a protocol created by patients in the diabetes community who wanted expanded access to their own data, and was adapted by BCH co-investigators to work entirely within the BCH firewall to access and share the data within BCH. Investigators will recruit individuals using their personal Dexcom G7 CGM in the hospital for clinical care, have the participants use the Dexcom G7 app on a hospital provided Android device, and will test the accuracy and efficiency of data capture by the companion app, all via secure BCH wifi or ethernet. On the hospital device, the Dexcom G7 app has been modified to send Android intra-application messages with CGM readings without identifying information to a companion app. The companion app will transmit the de-identified CGM data to a centralized hospital database that feeds into an internal BCH web dashboard for live data viewing, analysis, and integration into future clinical decision support tools. One anticipated future use of the companion app will be in an upcoming interventional clinical trial of ICU patients receiving IV insulin, in which CGM data will be used to guide insulin infusion rates.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pediatric diabetic Dexcom G7 users
Diabetic pediatric patients using their personal Dexcom G7 admitted for clinical care purposes.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Use of a Dexcom receiver to view data (rather than the typical mobile phone)
* Enrollment in a competing clinical trial
2 Weeks
24 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Children's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jessica Ruiz, MD
Physician, Endocrinology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boston Children's Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-P00049941
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.