Diabetes MellitusG4NCT01142895
Validation Study of G4 User Interface
An observational study of Diabetes Mellitus, run by Tandem Diabetes Care, Inc..
Trial summary
The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 2010
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Novice adult pumpers, experienced adult pumpers, and non-pumper adults
Who may be able to join
- Clinical diagnosis of diabetes mellitus
Who cannot join
None listed.
About this study
Official title: Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump
The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.
Read the detailed description
These are the detailed descriptive planned outcomes of this useability study.
- To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use.
- Validate that foreseeable misuse does not lead to a safety hazard or patient injury.
- Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142895
- Sponsor's protocol ID
- TDC-G4
- Acronym
- G4
- Status last verified
- Jun 2010
- First submitted
- 9 Jun 2010
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump
- ClinicalTrials.gov ID
- NCT01142895
- Acronym / sponsor ID
- G4 / TDC-G4
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- May 2010 (actual)
- First posted
- 11 Jun 2010 (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.
The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.
Detailed description
These are the detailed descriptive planned outcomes of this useability study.
- To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use.
- Validate that foreseeable misuse does not lead to a safety hazard or patient injury.
- Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Novice adult pumpers, experienced adult pumpers, and non-pumper adults
Key inclusion criteria (1 listed)
- Clinical diagnosis of diabetes mellitus
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 Jun 2010.
Related trials for Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Tandem Diabetes Care, Inc..
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 1 inclusion and 0 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 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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 11 Jun 2010.