Type 1 Diabetes MellitusIDEAL CGMNCT03367351
Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring
A study testing Web-Based Education and Social Support in people with Type 1 Diabetes Mellitus and Continuous Glucose Monitor, run by University of Florida at 1 site in United States.
Trial summary
The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Continuous Glucose Monitor
- What is being tested?
- Web-Based Education and Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 1 Nov 2018
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to read and speak English
- Diagnosed with type 1 diabetes (T1D) for > 3 months before consent is obtained
- Aged >15 years and <24 years at time of enrollment
- Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker
- Must be using/initiating a Dexcom CGM
Who cannot join
- Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol
- Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol
- Previous use of a CGM within the last 3 months
- Unwilling or unlikely to return to clinic for a follow-up HbA1c test
- Unwillingness to accept randomization
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based intervention represents an efficient way to bring together professionally-supported CGM educational materials and social support to overcome known barriers and address factors associated with inconsistent CGM use.
- Being tested
- Web-Based Education, Social Support, Standard of Care
- 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.
Web-Based EducationBehavioural
Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.
Social SupportBehavioural
Engagement in peer-led CGM specific discussion boards
Standard of CareBehavioural
Standard of Care - serves as the control group for the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Educational Intervention | Experimental | Participants receiving the Web-Based Educational Intervention will be enrolled to the research protocol for six weeks of module-based learning and online discussion sessions and followed for a total of 3-months post CGM implementation to collect study measures. Receives: Behavioral: Web-Based Education; Behavioral: Social Support |
| Standard of Care | Placebo comparator | Participants will receive standard clinical care. Similar study measures will be collected to compare between groups. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to CGM
Analyzing CGM data to determine if there is a difference in adherence between treatment and control group
Measured: 3 months
Secondary outcomes (3)
HbA1c
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.
Measured: 1-week run in, 3-months post implementation
CGM Satisfaction
Survey instrument that measures self-reported satisfaction with CGM use
Measured: 1-week run in, 7 weeks
CGM Self-Efficacy
Survey instrument that measures self-reported self-efficacy related to CGM use
Measured: 1-week run in, 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start9 Mar 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, un-blinded intervention/control design
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madison B Smith, BSN, PhD Candidate, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367351
- Sponsor's protocol ID
- UFT1DCGM2017
- Other IDs
- IRB201701822
- Acronym
- IDEAL CGM
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2017
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith MB, Albanese-O'Neill A, Yao Y, Wilkie DJ, Haller MJ, Keenan GM. Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. JMIR Diabetes. 2021 Feb 9;6(1):e15410. doi: 10.2196/15410.
PubMed 33560234
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT03367351
- Acronym / sponsor ID
- IDEAL CGM / UFT1DCGM2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 8 Dec 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 goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based intervention represents an efficient way to bring together professionally-supported CGM educational materials and social support to overcome known barriers and address factors associated with inconsistent CGM use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, un-blinded intervention/control design
| Arm | Type | Receives |
|---|---|---|
| Web-Based Educational Intervention | Experimental | Behavioral: Web-Based Education, Behavioral: Social SupportParticipants receiving the Web-Based Educational Intervention will be enrolled to the research protocol for six weeks of module-based learning and online discussion sessions and followed for a total of 3-months post CGM implementation to collect study measures. |
| Standard of Care | Placebo comparator | Behavioral: Standard of CareParticipants will receive standard clinical care. Similar study measures will be collected to compare between groups. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ability to read and speak English
- Diagnosed with type 1 diabetes (T1D) for > 3 months before consent is obtained
- Aged >15 years and <24 years at time of enrollment
- Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker
- Must be using/initiating a Dexcom CGM
Key exclusion criteria (5 listed)
- Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol
- Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol
- Previous use of a CGM within the last 3 months
- Unwilling or unlikely to return to clinic for a follow-up HbA1c test
- Unwillingness to accept randomization
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 |
|---|---|---|
| Web-Based EducationCompletion of a CGM specific web-based educational intervention that includes a series of online learning modules. | Behavioural | Web-Based Educational Intervention |
| Social SupportEngagement in peer-led CGM specific discussion boards | Behavioural | Web-Based Educational Intervention |
| Standard of CareStandard of Care - serves as the control group for the treatment arm | Behavioural | Standard of Care |
Primary outcome
Adherence to CGM
Time frame: 3 months
Analyzing CGM data to determine if there is a difference in adherence between treatment and control group
3 secondary outcomes
HbA1c
Time frame: 1-week run in, 3-months post implementation
CGM Satisfaction
Time frame: 1-week run in, 7 weeks
CGM Self-Efficacy
Time frame: 1-week run in, 7 weeks
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 17 Dec 2018.
- Derived from this study: PubMed 33560234Smith MB, Albanese-O'Neill A, Yao Y, Wilkie DJ, Haller MJ, Keenan GM. Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. JMIR Diabetes. 2021 Feb 9;6(1):e15410. doi: 10.2196/15410.
- 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.
Madison B Smith, BSN, PhD Candidate 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 study testing Web-Based Education and Social Support in people with Type 1 Diabetes Mellitus and Continuous Glucose Monitor, 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 5 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 17 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
Adherence to CGM (time frame: 3 months). 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 NCT03367351, 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 17 Dec 2018.