DiabetesNCT02757183
Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.
An observational study of Diabetes, run by AnalyticsPlus, Inc. at 1 site in United States.
Trial summary
The "INTELLIH" (brand name of the mobile health application) Diabetes Study is to understand the usage of a mobile health application, IntelliH, and connected wireless devices such as glucometer by the diabetic patients and ascertain if there are any improvements in short-term health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- "IntelliH"
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from the list of diabetes patients coming to Cedars-Sinai Medical Center for their regular treatment. Several physicians will be involved in making this program available to their patients. Eligible and consenting patients will be recruited.
Who may be able to join
- A1c greater than or equal to 6.5%.
- Age greater than or equal to 18 years.
- Ability to comply with study protocol.
- Available and usable internet facilities at home.
- Availability and usable smart phone.
Who cannot join
- -Inability to comply with instructions and directions.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The "INTELLIH" (brand name of the mobile health application) Diabetes Study is to understand the usage of a mobile health application, IntelliH, and connected wireless devices such as glucometer by the diabetic patients and ascertain if there are any improvements in short-term health outcomes.
Read the detailed description
The proposed pilot program is the first of its kind in the nation to use a product, "IntelliH" - Intelligent Health for All, that combines four key technologies in one platform: 1) Mobile health application (mHealth) App and web portal, 2) wireless sensors and wearable devices, 3) Secure text messaging when both sender and receiver are logged in to the system and video-based patient interaction, and 4) remote health monitoring. The purpose of this pilot program is to understand a) usage and adoption of these technologies by providers and patients, and b) document the short-term improvements in health outcomes in a diabetic population. This pilot study will follow 20 diabetic patients (Type 1 or Type 2) as they beta-test this system, and will acquire data on consented subjects over a period of six months.
- Conditions
- Diabetes
- Being tested
- "IntelliH"
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"IntelliH"Device
"IntelliH" is a mobile health and a web-based software application that allows patients to enter their blood glucose, weight, medication, diet and other life-style data for review by their providers and monitor their health remotely.
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage and Adoption of the smart phone based mobile health application
Patients adoption will be assessed directly through the application and through questionnaire
Measured: Six Months
Secondary outcomes (2)
Blood glucose range maintenance and variation
Frequency of hypoglycemic, hyperglycemic, and out of recommended range events
Measured: Six months
Adherence to Prescribed Medication
Medication adherence rates will be measured for each medication used by patient
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnalyticsPlus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor
- Investigators
- Ruchi Mathur, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757183
- Sponsor's protocol ID
- Pro-00041208-AP
- Status last verified
- May 2016
- First submitted
- 27 Apr 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.
- ClinicalTrials.gov ID
- NCT02757183
- Acronym / sponsor ID
- Pro-00041208-AP
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AnalyticsPlus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 2 May 2016 (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 "INTELLIH" (brand name of the mobile health application) Diabetes Study is to understand the usage of a mobile health application, IntelliH, and connected wireless devices such as glucometer by the diabetic patients and ascertain if there are any improvements in short-term health outcomes.
Detailed description
The proposed pilot program is the first of its kind in the nation to use a product, "IntelliH" - Intelligent Health for All, that combines four key technologies in one platform: 1) Mobile health application (mHealth) App and web portal, 2) wireless sensors and wearable devices, 3) Secure text messaging when both sender and receiver are logged in to the system and video-based patient interaction, and 4) remote health monitoring. The purpose of this pilot program is to understand a) usage and adoption of these technologies by providers and patients, and b) document the short-term improvements in health outcomes in a diabetic population. This pilot study will follow 20 diabetic patients (Type 1 or Type 2) as they beta-test this system, and will acquire data on consented subjects over a period of six months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from the list of diabetes patients coming to Cedars-Sinai Medical Center for their regular treatment. Several physicians will be involved in making this program available to their patients. Eligible and consenting patients will be recruited.
Key inclusion criteria (5 listed)
- A1c greater than or equal to 6.5%.
- Age greater than or equal to 18 years.
- Ability to comply with study protocol.
- Available and usable internet facilities at home.
- Availability and usable smart phone.
Key exclusion criteria (1 listed)
- -Inability to comply with instructions and directions.
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 |
|---|---|---|
| "IntelliH""IntelliH" is a mobile health and a web-based software application that allows patients to enter their blood glucose, weight, medication, diet and other life-style data for review by their providers and monitor their health remotely. | Device | – |
Primary outcome
Usage and Adoption of the smart phone based mobile health application
Time frame: Six Months
Patients adoption will be assessed directly through the application and through questionnaire
2 secondary outcomes
Blood glucose range maintenance and variation
Time frame: Six months
Adherence to Prescribed Medication
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Ruchi Mathur, MD principal investigator
Cedars-Sinai Medical Center
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, run by AnalyticsPlus, Inc. 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 1 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: status not confirmed, as of the sponsor's last update on 13 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruchi Mathur, MD ((310) 423-4295, Ruchi.mathur@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage and Adoption of the smart phone based mobile health application (time frame: Six Months). 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 13 May 2016.