Type 1 DiabetesNCT04696640
Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
A study testing Remote Patient Monitoring in people with Type 1 Diabetes, run by University of California, Davis at 1 site in United States.
Trial summary
This project explores the feasibility and utility of remote glucose monitoring for a cohort of children and adolescents with type 1 diabetes (T1D) cared for at UC Davis Health (UCDH). Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Remote Patient Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnoses of type 1 diabetes with a duration of greater than or equal to 12 months
- Use of a continuous glucose monitor (CGM) for greater than or equal to 6 months
- Intention to continue receiving care at the UC Davis Health Pediatric Diabetes clinic.
Who cannot join
- Patient's CGM cannot be uploaded to Glooko
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
This project explores the feasibility and utility of remote glucose monitoring for a cohort of children and adolescents with type 1 diabetes (T1D) cared for at UC Davis Health (UCDH).
- Conditions
- Type 1 Diabetes
- Being tested
- Remote Patient Monitoring
- 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.
Remote Patient MonitoringBehavioural
Participants' glucose data will be monitored by the study team using population analytic reports. Participants who either have excessive hypoglycemia or hyperglycemia on these reports will be contacted by a pediatric endocrinologist (the principal investigator) to discuss any necessary adjustments to their home diabetes management plans. This intervention will be in addition to their usual care (regular visits at the UC Davis Pediatric Endocrinology clinic).
| Study group | Role | What they receive |
|---|---|---|
| Remote Patient Monitoring | Experimental | All participants who have successfully established remote data-sharing from their glucose monitors to the research team's Glooko account by conclusion of the one-month baseline period will advance to the six-month intervention period. Receives: Behavioral: Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health
Proportion of participants who have successfully established remote glucose monitoring by the end of the baseline period.
Measured: 1 month baseline period
Change in hemoglobin A1c (HbA1c)
HbA1c at study completion minus the HbA1c at initiation
Measured: Initiation = 1 month after enrollment, Study completion = 7 months after enrollment
Secondary outcomes (6)
Data-sharing experience survey
Survey asking about patient's experience with data-sharing
Measured: 1 month after enrollment
Target Glucose Range
Percentage of time spent in target glucose range (generated from continuous glucose monitor)
Measured: Months 1-7 after enrollment
Hyperglycemic range
Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor)
Measured: Months 1-7 after enrollment
Hypoglycemic range
Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor)
Measured: Months 1-7 after enrollment
Overall continuous glucose monitor (CGM) wear time
Percentage of time spent wearing continuous glucose monitor (generated from continuous glucose monitor)
Measured: Months 1-7 after enrollment
Remote patient monitoring survey
Survey asking about patient's experience with remote patient monitoring
Measured: Month 7 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start3 Jun 2021
- Primary completion18 Apr 2022
- Study completion25 May 2022
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 University of California, DavisThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696640
- Sponsor's protocol ID
- 1638182
- Status last verified
- May 2022
- First submitted
- 4 Jan 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crossen SS, Romero CC, Lewis C, Glaser NS. Remote glucose monitoring is feasible for patients and providers using a commercially available population health platform. Front Endocrinol (Lausanne). 2023 Feb 2;14:1063290. doi: 10.3389/fendo.2023.1063290. eCollection 2023.
PubMed 36817610
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04696640
- Acronym / sponsor ID
- 1638182
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 6 Jan 2021 (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.
This project explores the feasibility and utility of remote glucose monitoring for a cohort of children and adolescents with type 1 diabetes (T1D) cared for at UC Davis Health (UCDH).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Patient Monitoring | Experimental | Behavioral: Remote Patient MonitoringAll participants who have successfully established remote data-sharing from their glucose monitors to the research team's Glooko account by conclusion of the one-month baseline period will advance to the six-month intervention period. |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnoses of type 1 diabetes with a duration of greater than or equal to 12 months
- Use of a continuous glucose monitor (CGM) for greater than or equal to 6 months
- Intention to continue receiving care at the UC Davis Health Pediatric Diabetes clinic.
Key exclusion criteria (1 listed)
- Patient's CGM cannot be uploaded to Glooko
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 |
|---|---|---|
| Remote Patient MonitoringParticipants' glucose data will be monitored by the study team using population analytic reports. Participants who either have excessive hypoglycemia or hyperglycemia on these reports will be contacted by a pediatric endocrinologist (the principal investigator) to discuss any necessary adjustments to their home diabetes management plans. This intervention will be in addition to their usual care (regular visits at the UC Davis Pediatric Endocrinology clinic). | Behavioural | Remote Patient Monitoring |
Primary outcome
Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health
Time frame: 1 month baseline period
Proportion of participants who have successfully established remote glucose monitoring by the end of the baseline period.
Change in hemoglobin A1c (HbA1c)
Time frame: Initiation = 1 month after enrollment, Study completion = 7 months after enrollment
HbA1c at study completion minus the HbA1c at initiation
6 secondary outcomes
Data-sharing experience survey
Time frame: 1 month after enrollment
Target Glucose Range
Time frame: Months 1-7 after enrollment
Hyperglycemic range
Time frame: Months 1-7 after enrollment
Hypoglycemic range
Time frame: Months 1-7 after enrollment
Overall continuous glucose monitor (CGM) wear time
Time frame: Months 1-7 after enrollment
Remote patient monitoring survey
Time frame: Month 7 after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 36817610Crossen SS, Romero CC, Lewis C, Glaser NS. Remote glucose monitoring is feasible for patients and providers using a commercially available population health platform. Front Endocrinol (Lausanne). 2023 Feb 2;14:1063290. doi: 10.3389/fendo.2023.1063290. eCollection 2023.
- Learn more or sign up for the study here!Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring in people with Type 1 Diabetes, run by University of California, Davis 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 1 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: finished, as of the sponsor's last update on 2 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health (time frame: 1 month baseline period). The study lists 2 primary outcomes in all. 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 NCT04696640, 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 2 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.