Type 1 Diabetes MellitusPhase 1T1D-DATANCT03228004
Type 1 Diabetes Data Acquisition and Transfer Adherence Study
A Phase 1 study testing Glooko MeterSync in people with Type 1 Diabetes Mellitus, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Glooko MeterSync
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 8 Apr 2019
- Phase
- Phase 1
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis with T1D at least 6 months before consent is obtained
- Aged ≥ 2 years and ≤17 years at time of enrollment
- Must have access to a smartphone, tablet or computer at home with wireless connectivity
- Last HbA1c of ≥7.6% and ≤11%
- Using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen
- Ability to read and speak English
- Patient at UF Health Pediatric Diabetes Clinic
Who cannot join
- Significant medical comorbidity in the child or adolescent that could, in the opinion of the PI, affect participant's capacity to complete study follow up
- Inability to read and speak English
- Not using insulin therapy
- Lack of access to mobile device or computer with wireless internet connectivity
- Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data upload
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Glooko MeterSync
- 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.
Glooko MeterSyncBehavioural
The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits. Receives: Behavioral: Glooko MeterSync |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved glycemic control
HbA1c
Measured: 16 weeks
Frequency of data upload
The number of times glucose data is uploaded between clinic visits
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start26 Jul 2017
- Primary completion24 Apr 2018
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastasia Albanese-O'Neill, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228004
- Sponsor's protocol ID
- IRB201700818
- Acronym
- T1D-DATA
- Status last verified
- Apr 2019
- First submitted
- 21 Jul 2017
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Data Acquisition and Transfer Adherence Study
- ClinicalTrials.gov ID
- NCT03228004
- Acronym / sponsor ID
- T1D-DATA / IRB201700818
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 24 Jul 2017 (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.
The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Glooko MeterSyncParticipants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis with T1D at least 6 months before consent is obtained
- Aged ≥ 2 years and ≤17 years at time of enrollment
- Must have access to a smartphone, tablet or computer at home with wireless connectivity
- Last HbA1c of ≥7.6% and ≤11%
- Using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen
Key exclusion criteria (5 listed)
- Significant medical comorbidity in the child or adolescent that could, in the opinion of the PI, affect participant's capacity to complete study follow up
- Inability to read and speak English
- Not using insulin therapy
- Lack of access to mobile device or computer with wireless internet connectivity
- Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data upload
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 |
|---|---|---|
| Glooko MeterSyncThe participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis. | Behavioural | Intervention Group |
Primary outcome
Improved glycemic control
Time frame: 16 weeks
HbA1c
Frequency of data upload
Time frame: 16 weeks
The number of times glucose data is uploaded between clinic visits
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 12 Apr 2019.
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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.
Anastasia Albanese-O'Neill, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glooko MeterSync in people with Type 1 Diabetes Mellitus, run by University of Florida 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 7 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: finished, as of the sponsor's last update on 12 Apr 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improved glycemic control (time frame: 16 weeks). 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?
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 12 Apr 2019.