Diabetes Mellitus, Type 1NCT02434094
Development of a Comprehensive AP Training Curriculum for Adults
An observational study of Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- eDAPT on-line training program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Aug 2015
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * clinicians who manage patients on insulin pumps and continuous glucose monitors * participants former study participants who have experience operating DiAs. * participants who wear an insulin pump and continuous glucose monitor but have no experience DiAs.
Diabetes Clinicians Inclusion Criteria:
- Endocrinologist, Certified Diabetes Educator, Nurse Practitioner actively managing patients with type 1 diabetes on insulin pumps and continuous glucose monitoring therapy
- Actively managing patients using insulin pumps for at least one year
Former \& Novice Study Subjects Inclusion Criteria:
- Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 1 year
- No previous experience with the artificial pancreas system in a clinical trial
- Currently using insulin pump to manage their type 1 diabetes for at least one year
- Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin
- Knowledge of continuous glucose monitors
Former Study Subjects Inclusion Criteria:
- Previous experience with the artificial pancreas system in a clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).
Read the detailed description
This project will develop and test a comprehensive, web based training system for the artificial pancreas (AP) prototype identified as eDAPT (electronic Diabetes Artificial Pancreas Training). This e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs), a software platform for the development and outpatient testing of smart phone based systems for Closed Loop Control of diabetes. The e-learning training program will be used in adjunct to in-person training with study staff at the onset of a clinical trial. It will be especially important as the number of clinical sites that use DiAs continue to grow both in the United States and internationally. It is also a critical step in moving the DiAs closer to a commercial product. A validated training program is required to proceed with the Food and Drug Administration (FDA) for both pivotal clinical trials and commercial approval of the AP.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- eDAPT on-line training program
- Keywords
- Diabetes Assistant (DiAs), Continuous Glucose Monitor (CGM), Insulin Pump, Human Factors, Focus Group, Artificial Pancreas (AP), eDAPT (electronic Diabetes Artificial Pancreas Training)
- 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.
eDAPT on-line training programBehavioural
A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.
| Study group | Role | What they receive |
|---|---|---|
| T1DM Clinicians | Clinicals currently teaching T1DM patients how to use insulin pumps and continuous glucose monitors will be asked to complete the eDAPT on-line training program. Receives: Behavioral: eDAPT on-line training program | |
| T1DM Subjects with DiAs experience | T1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program. Receives: Behavioral: eDAPT on-line training program | |
| T1DM Subjects with no prior DiAs experience | T1DM subjects will no prior DiAs experience will be asked to complete the eDAPT on-line training program. Receives: Behavioral: eDAPT on-line training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated eDAPT training tool
Subjects learn how to properly operate \& configure DiAs.
Measured: 2 hours
Human factors feedback
Administration of knowledge tests and focus groups
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Brown, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, UVA Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434094
- Sponsor's protocol ID
- 18032
- Status last verified
- Oct 2016
- First submitted
- 29 Apr 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Comprehensive AP Training Curriculum for Adults
- ClinicalTrials.gov ID
- NCT02434094
- Acronym / sponsor ID
- 18032
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Assistant (DiAs), Continuous Glucose Monitor (CGM), Insulin Pump, Human Factors, Focus Group, Artificial Pancreas (AP), eDAPT (electronic Diabetes Artificial Pancreas Training)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 May 2015 (estimated)
- 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.
An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).
Detailed description
This project will develop and test a comprehensive, web based training system for the artificial pancreas (AP) prototype identified as eDAPT (electronic Diabetes Artificial Pancreas Training). This e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs), a software platform for the development and outpatient testing of smart phone based systems for Closed Loop Control of diabetes. The e-learning training program will be used in adjunct to in-person training with study staff at the onset of a clinical trial. It will be especially important as the number of clinical sites that use DiAs continue to grow both in the United States and internationally. It is also a critical step in moving the DiAs closer to a commercial product. A validated training program is required to proceed with the Food and Drug Administration (FDA) for both pivotal clinical trials and commercial approval of the AP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T1DM Clinicians | – | Behavioral: eDAPT on-line training programClinicals currently teaching T1DM patients how to use insulin pumps and continuous glucose monitors will be asked to complete the eDAPT on-line training program. |
| T1DM Subjects with DiAs experience | – | Behavioral: eDAPT on-line training programT1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program. |
| T1DM Subjects with no prior DiAs experience | – | Behavioral: eDAPT on-line training programT1DM subjects will no prior DiAs experience will be asked to complete the eDAPT on-line training program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * clinicians who manage patients on insulin pumps and continuous glucose monitors * participants former study participants who have experience operating DiAs. * participants who wear an insulin pump and continuous glucose monitor but have no experience DiAs.
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 |
|---|---|---|
| eDAPT on-line training programA series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs. | Behavioural | T1DM Clinicians, T1DM Subjects with DiAs experience, T1DM Subjects with no prior DiAs experience |
Primary outcome
Validated eDAPT training tool
Time frame: 2 hours
Subjects learn how to properly operate \& configure DiAs.
Human factors feedback
Time frame: 2 hours
Administration of knowledge tests and focus groups
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 25 Oct 2016.
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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.
Sue Brown, MD principal investigator
UVA Center for Diabetes Technology
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 Mellitus, Type 1, run by University of Virginia 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?
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 25 Oct 2016. 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?
Validated eDAPT training tool (time frame: 2 hours). 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 25 Oct 2016.