Type 1 DiabetesNCT03968055
Remote Monitoring of CGM Data in Pediatric Patients With Newly Diagnosed Type 1 Diabetes (T1D)
A study testing Integration with Epic in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
To determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. We will be using the GluVue platform to remotely view continuous glucose monitor (CGM) data. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Integration with Epic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 30 Dec 2028
- Phase
- Interventional
- 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 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic
- Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic
- Individuals who agree to CGM data integration into the electronic medical record (EMR) for remote monitoring
- Age: birth to < 21 years of age
Who cannot join
- Diabetes diagnosis other than T1D
- Diagnosis of diabetes > 1 month prior to initial visit
- Individuals with the intention of obtaining diabetes care at another clinic
- Individuals who do not consent to CGM use, CGM data integration, or remote monitoring
- Individuals > 21 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94305
About this study
Official title: The Use of Continuous Glucose Monitor Technology and Remote Monitoring to Change Clinical Outcomes Following New Diagnosis of Type 1 Diabetes in the Pediatric Population
To determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. We will be using the GluVue platform to remotely view continuous glucose monitor (CGM) data.
Read the detailed description
Based on alerts from GluVue, care team members will proactively reach out to patients and their families for more frequent dose adjustments. We will assess if remote monitoring facilitates contact between the care team and patients and improves glycemic control.
- Conditions
- Type 1 Diabetes
- Being tested
- Integration with Epic
- Keywords
- pediatrics
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integration with EpicOther
Also called GluVue Platform
Participants will have CGM data connected to our medical record through an already established pathway (Dexcom app on iOS device to Apple HealthKit to Epic MyChart to Epic)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 1 Diabetes | Other | Participants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team. Receives: Other: Integration with Epic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contacts with the care provider
Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring
Measured: 1 year
Secondary outcomes (1)
Hemoglobin A1c
Prospective chart review for lab values
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start25 Mar 2019
- Primary completion30 Dec 2025
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priya Prahalad, Stanford University
- Investigators
- Priya Prahalad, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968055
- Sponsor's protocol ID
- 48935
- Status last verified
- May 2026
- First submitted
- 28 May 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prahalad P, Ding VY, Zaharieva DP, Addala A, Johari R, Scheinker D, Desai M, Hood K, Maahs DM. Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Type 1 Diabetes: the Pilot 4T Study. J Clin Endocrinol Metab. 2022 Mar 24;107(4):998-1008. doi: 10.1210/clinem/dgab859.
PubMed 34850024
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Continuous Glucose Monitor Technology and Remote Monitoring to Change Clinical Outcomes Following New Diagnosis of Type 1 Diabetes in the Pediatric Population
- ClinicalTrials.gov ID
- NCT03968055
- Acronym / sponsor ID
- 48935
- Conditions
- Type 1 Diabetes
- Keywords
- pediatrics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 30 May 2019 (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.
To determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. We will be using the GluVue platform to remotely view continuous glucose monitor (CGM) data.
Detailed description
Based on alerts from GluVue, care team members will proactively reach out to patients and their families for more frequent dose adjustments. We will assess if remote monitoring facilitates contact between the care team and patients and improves glycemic control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 1 Diabetes | Other | Other: Integration with EpicParticipants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic
- Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic
- Individuals who agree to CGM data integration into the electronic medical record (EMR) for remote monitoring
- Age: birth to < 21 years of age
Key exclusion criteria (5 listed)
- Diabetes diagnosis other than T1D
- Diagnosis of diabetes > 1 month prior to initial visit
- Individuals with the intention of obtaining diabetes care at another clinic
- Individuals who do not consent to CGM use, CGM data integration, or remote monitoring
- Individuals > 21 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integration with EpicAlso: GluVue PlatformParticipants will have CGM data connected to our medical record through an already established pathway (Dexcom app on iOS device to Apple HealthKit to Epic MyChart to Epic) | Other | Patients with Type 1 Diabetes |
Primary outcome
Contacts with the care provider
Time frame: 1 year
Prospective chart review to determine the number of contacts between the participant and care team due to remote monitoring
1 secondary outcome
Hemoglobin A1c
Time frame: 1 year
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 8 May 2026.
- Derived from this study: PubMed 34850024Prahalad P, Ding VY, Zaharieva DP, Addala A, Johari R, Scheinker D, Desai M, Hood K, Maahs DM. Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Type 1 Diabetes: the Pilot 4T Study. J Clin Endocrinol Metab. 2022 Mar 24;107(4):998-1008. doi: 10.1210/clinem/dgab859.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Priya Prahalad, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integration with Epic in people with Type 1 Diabetes, run by Stanford University 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 8 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contacts with the care provider (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968055, which also lists 1 linked publication.
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 8 May 2026.