Diabetes MellitusNCT01983917
Mobile Application to Enhance Diabetic Care
A study testing Diabetes Mobile Application in people with Diabetes Mellitus, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Prospective study to evaluate whether or not an internet application to coordinate and record diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical care team and 3. ophthalmology vision care team will decrease vision loss and blindness due to diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diabetes Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2014
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with diabetes mellitus and receiving care from either Jules Stein Eye Institute or the Gonda Diabetes Center at UCLA.
- Between 14 and 75 years if age at the time of enrollment.
- Internet access with Apple i-Phone, Apple i-Pad, and/or Apple i-Pod Touch on a weekly basis.
- English language and Internet capability for data entry, monitoring, and comprehension of reports.
- Able to attend Standard of Care visits for 1 to 3 years.
- Able to understand and willing to sign the informed consent perform and comply with all study procedures
Who cannot join
- Any social, mental or physical condition that impairs ability to give consent, maintain Internet access or attend physician visits.
- Prior or concurrent eye or vision condition that would interfere with participation in or interpretation of the study.
- Prior or concurrent disease or medical condition that is likely to compromise interpretation of the study.
- 3. Inability or unwillingness of the patient's diabetes medical care or ophthalmology vision care team to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jules Stein Eye Institute
Los Angeles, California, 90095
About this study
Official title: Clinical Trial of Mobile Application to Enhance Diabetic Health Care
Prospective study to evaluate whether or not an internet application to coordinate and record diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical care team and 3. ophthalmology vision care team will decrease vision loss and blindness due to diabetic retinopathy. The aims will be measured through health psychology instruments to assess the effect of the application on management, motivation to control their disease, and commitment to comply with treatment. We will also measure objective health outcomes including Blood Pressure, Blood lipids level, hemoglobin A1c level, and Visual Acuity.
Read the detailed description
This community-based study will involve the participation of healthcare professionals and physicians who are already treating the patient. Support and adequate training of the mobile application and the research protocol will be provided by the Study Coordinator.
The patient/family caregiver be asked to check their vision at home via their mobile application at regularly scheduled intervals as determined by their ophthalmologist. Patients will be expected to review postings of their visual acuity and office visits at a minimum of once a month intervals.
A staff member from the physician's office will post pertinent data from each office visit using a template. The ophthalmology template will include visual acuity, intraocular pressure, treatments given (if any), and uploaded retinal images. The non-ophthalmology physicians will post their office visit data in a free-form text box. Data entry can be performed by office staff and does not have to be done by a physician. Physicians will have access to view visual acuity records and physician postings from their own patients.
The research coordinator will collect health psychology data by administering validated health psychology questionnaires to assess patient depression, knowledge regarding diabetes and complications of diabetes, motivation to carry out diabetes care, reaction to increased knowledge of specific tests for diabetes and diabetic complications, and quality of life at 4-month intervals throughout the Clinical Trial.
- Conditions
- Diabetes Mellitus
- Being tested
- Diabetes Mobile Application
- Keywords
- diabetes, mobile application, diabetic retinopathy
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Mobile ApplicationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Use of the Diabetes Application | Other | Not described Receives: Behavioral: Diabetes Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of diabetic retinopathy risk factors
risk factors normalization by assessment of hemoglobin A1c percent, blood lipids level and blood pressure level as continuous variables.
Measured: 1 year
Secondary outcomes (1)
Motivation for adhering to treatment recommendations and follow-up
Validated health psychology interments will be administer at enrollment and periodically during follow-up.
Measured: every 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionDec 2014
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.
- More trials run by University of California, Los AngelesThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irena Tsui, M.D., University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983917
- Sponsor's protocol ID
- 12-001117
- Status last verified
- May 2016
- First submitted
- 30 Oct 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Mobile Application to Enhance Diabetic Health Care
- ClinicalTrials.gov ID
- NCT01983917
- Acronym / sponsor ID
- 12-001117
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, mobile application, diabetic retinopathy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Nov 2013 (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.
Prospective study to evaluate whether or not an internet application to coordinate and record diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical care team and 3. ophthalmology vision care team will decrease vision loss and blindness due to diabetic retinopathy. The aims will be measured through health psychology instruments to assess the effect of the application on management, motivation to control their disease, and commitment to comply with treatment. We will also measure objective health outcomes including Blood Pressure, Blood lipids level, hemoglobin A1c level, and Visual Acuity.
Detailed description
This community-based study will involve the participation of healthcare professionals and physicians who are already treating the patient. Support and adequate training of the mobile application and the research protocol will be provided by the Study Coordinator.
The patient/family caregiver be asked to check their vision at home via their mobile application at regularly scheduled intervals as determined by their ophthalmologist. Patients will be expected to review postings of their visual acuity and office visits at a minimum of once a month intervals.
A staff member from the physician's office will post pertinent data from each office visit using a template. The ophthalmology template will include visual acuity, intraocular pressure, treatments given (if any), and uploaded retinal images. The non-ophthalmology physicians will post their office visit data in a free-form text box. Data entry can be performed by office staff and does not have to be done by a physician. Physicians will have access to view visual acuity records and physician postings from their own patients.
The research coordinator will collect health psychology data by administering validated health psychology questionnaires to assess patient depression, knowledge regarding diabetes and complications of diabetes, motivation to carry out diabetes care, reaction to increased knowledge of specific tests for diabetes and diabetic complications, and quality of life at 4-month intervals throughout the Clinical Trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of the Diabetes Application | Other | Behavioral: Diabetes Mobile Application |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with diabetes mellitus and receiving care from either Jules Stein Eye Institute or the Gonda Diabetes Center at UCLA.
- Between 14 and 75 years if age at the time of enrollment.
- Internet access with Apple i-Phone, Apple i-Pad, and/or Apple i-Pod Touch on a weekly basis.
- English language and Internet capability for data entry, monitoring, and comprehension of reports.
- Able to attend Standard of Care visits for 1 to 3 years.
Key exclusion criteria (4 listed)
- Any social, mental or physical condition that impairs ability to give consent, maintain Internet access or attend physician visits.
- Prior or concurrent eye or vision condition that would interfere with participation in or interpretation of the study.
- Prior or concurrent disease or medical condition that is likely to compromise interpretation of the study.
- 3. Inability or unwillingness of the patient's diabetes medical care or ophthalmology vision care team to participate.
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 |
|---|---|---|
| Diabetes Mobile Application | Behavioural | Use of the Diabetes Application |
Primary outcome
Change of diabetic retinopathy risk factors
Time frame: 1 year
risk factors normalization by assessment of hemoglobin A1c percent, blood lipids level and blood pressure level as continuous variables.
1 secondary outcome
Motivation for adhering to treatment recommendations and follow-up
Time frame: every 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
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 Diabetes Mobile Application in people with Diabetes Mellitus, run by University of California, Los Angeles 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Change of diabetic retinopathy risk factors (time frame: 1 year). 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 May 2016.