DiabetesCLICKNCT06899503
Creating Linked Inpatient CGM for Kids
An observational study of Diabetes and Continuous Glucose Monitoring System, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 24 years
- Conditions the study is for
- Diabetes, Continuous Glucose Monitoring System
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
Jessica L Ruiz, MD, 617-355-7241, Jessica.Ruiz@childrens.harvard.edu
Michael SD Agus, MD, 617-355-5849, Michael.Agus@childrens.harvard.edu
About this study
Official title: CLICK: Creating Linked Inpatient CGM for Kids
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.
Read the 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 accuracy is verified daily.
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
- Diabetes, Continuous Glucose Monitoring System
- Keywords
- Diabetes, Continuous glucose monitoring system, Android application
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric diabetic Dexcom G7 users | Diabetic pediatric patients using their personal Dexcom G7 admitted for clinical care purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Ruiz, MD, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899503
- Sponsor's protocol ID
- IRB-P00049941
- Acronym
- CLICK
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLICK: Creating Linked Inpatient CGM for Kids
- ClinicalTrials.gov ID
- NCT06899503
- Acronym / sponsor ID
- CLICK / IRB-P00049941
- Conditions
- Diabetes, Continuous Glucose Monitoring System
- Keywords
- Diabetes, Continuous glucose monitoring system, Android application
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 accuracy is verified daily.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric diabetic Dexcom G7 users | – | –Diabetic pediatric patients using their personal Dexcom G7 admitted for clinical care purposes. |
Who may qualify
- Ages
- 2 weeks to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of CGM data capture.
Time frame: The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.
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.
1 secondary outcome
Efficiency of CGM data capture.
Time frame: The earlier of a maximum of 20 days or 72 hours following the first sensor exchange.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Continuous Glucose Monitoring System, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica L Ruiz, MD (617-355-7241, Jessica.Ruiz@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.