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Creating Linked Inpatient CGM for Kids (CLICK) 20 Mobile App Observational

Not yet recruiting
Clinical Trial NCT06899503 (CLICK) is an observational study for Diabetes, Continuous Glucose Monitoring System and is currently not yet recruiting. Enrollment is planned to begin on January 1, 2027 and continue until the study accrues 20 participants. Led by Boston Children's Hospital, this study is expected to complete by January 1, 2028. The latest data from ClinicalTrials.gov was last updated on April 3, 2026.
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 g...Show More
Detailed Description
Continuous glucose monitors are currently used in the inpatient setting at Boston Children's Hospital (BCH) for the care of patients with diabetes and for research studies. CGMs measure and display patient's glucose level every 5 minutes and provide alerts for predicted or actual low or high glucose levels. BCH policy allows for use of Dexcom G6 and G7 CGM for glucose monitoring and insulin dosing, so long as the CGM...Show More
Official Title

CLICK: Creating Linked Inpatient CGM for Kids

Conditions
DiabetesContinuous Glucose Monitoring System
Other Study IDs
  • CLICK
  • IRB-P00049941
NCT ID Number
Start Date (Actual)
2027-01
Last Update Posted
2026-04-03
Completion Date (Estimated)
2028-01
Enrollment (Estimated)
20
Study Type
Observational
Status
Not yet recruiting
Keywords
Diabetes
Continuous glucose monitoring system
Android application
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Pediatric diabetic Dexcom G7 users
Diabetic pediatric patients using their personal Dexcom G7 admitted for clinical care purposes.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
2 Weeks
Eligible Sexes
All
  • 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

  • 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
Boston Children's Hospital logoBoston Children's Hospital
Study Responsible Party
Jessica Ruiz, MD, Principal Investigator, Physician, Endocrinology, Boston Children's Hospital
Study Central Contact
Contact: Jessica L Ruiz, MD, 617-355-7241, [email protected]
Contact: Michael SD Agus, MD, 617-355-5849, [email protected]
1 Study Locations in 1 Countries

Massachusetts

Boston Children's Hospital, Boston, Massachusetts, 02115, United States
Jessica L Ruiz, MD, Contact, 617-355-7241, [email protected]
Michael SD Agus, MD, Contact, 617-355-5849, [email protected]