Diabetes Mellitus, Type 2NCT03222284
The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App
A study testing Cornerstones4Care Powered by Glooko App in people with Diabetes Mellitus, Type 2, run by Healthcare Innovation Technology Lab at 1 site in United States.
Trial summary
This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes who use a blood glucose meter as part of their treatment regimen. Participants will have either two or three visits at HITLAB during the 28-day study period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Cornerstones4Care Powered by Glooko App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 30 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with type 2 diabetes
- Live in the New York Metropolitan area
- Be at least 18 years of age
- Able to read, write, and speak in English
- Have an iPhone or Android phone
- Use a blood glucose meter
- Regularly take insulin by injection
- Be willing to follow study requirements for a 28-day period
Who cannot join
- Not be diagnosed with type 2 diabetes
- Not living in the New York Metropolitan area
- Be less than 18 years of age
- Be unable to read, write, and speak in English
- Not have an iPhone or Android phone
- Not use a blood glucose meter
- Not regularly take insulin by injection
- Be unwilling to follow study requirements for a 28-day period
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Healthcare Innovation and Technology Lab
New York, New York, 10032
Claire Gutermuth, 917-349-2528, C4C@hitlab.org
About this study
This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes who use a blood glucose meter as part of their treatment regimen. Participants will have either two or three visits at HITLAB during the 28-day study period.
Read the detailed description
The purpose of this study is to evaluate the utility and user experience of a mobile application, called Cornerstones4Care Powered by Glooko App (C4C), for persons diagnosed with diabetes type 2.Subjects will be asked to use the Cornerstones4Care Powered by Glooko App for an approximately 20 minute monitored demonstration session, followed by a 28-day period of daily engagement with the application.The Cornerstones4Care Powered by Glooko App lets users input nutrition, medication, exercise and other daily information to assist in the management of diabetes type 2. It also has the ability to sync with connected devices, such as blood glucose monitors. Additionally, the application offers a library of educational content for users.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Cornerstones4Care Powered by Glooko App
- Keywords
- diabetes, type 2 diabetes, type ii diabetes, insulin, mobile applications, Diabetes Mellitus, Diabetes Mellitus, Type 2, smartphone application, health application
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornerstones4Care Powered by Glooko AppDevice
Cornerstones4Care Powered by Glooko App is an iOS or Android smartphone application designed to support diabetes management by offering people with diabetes easily accessible, personalized tools for self-monitoring and education. C4C allows people with diabetes to monitor personal health metrics and blood glucose levels, with the aim to achieve participant behavior changes that may contribute to lower hospitalizations, diabetes-related complications and overall healthcare costs.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | N=10 Device intervention
1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28 Receives: Device: Cornerstones4Care Powered by Glooko App |
| Group 2 | Experimental | N=20 Device intervention
1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28 Receives: Device: Cornerstones4Care Powered by Glooko App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of the Cornerstones4Care Powered by Glooko App as assessed by self-report
Measured: 28 days
Device usability as assessed by the System Usability Scale (SUS)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start17 Jul 2017
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthcare Innovation Technology Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Stan Kachnowski, PhD, MPP, Principal investigator, Healthcare Innovation Technology Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222284
- Sponsor's protocol ID
- Pro00022321
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App
- ClinicalTrials.gov ID
- NCT03222284
- Acronym / sponsor ID
- Pro00022321
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, type 2 diabetes, type ii diabetes, insulin, mobile applications, Diabetes Mellitus, Diabetes Mellitus, Type 2, smartphone application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Healthcare Innovation Technology LabIndustry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 19 Jul 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.
This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes who use a blood glucose meter as part of their treatment regimen. Participants will have either two or three visits at HITLAB during the 28-day study period.
Detailed description
The purpose of this study is to evaluate the utility and user experience of a mobile application, called Cornerstones4Care Powered by Glooko App (C4C), for persons diagnosed with diabetes type 2.Subjects will be asked to use the Cornerstones4Care Powered by Glooko App for an approximately 20 minute monitored demonstration session, followed by a 28-day period of daily engagement with the application.The Cornerstones4Care Powered by Glooko App lets users input nutrition, medication, exercise and other daily information to assist in the management of diabetes type 2. It also has the ability to sync with connected devices, such as blood glucose monitors. Additionally, the application offers a library of educational content for users.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Cornerstones4Care Powered by Glooko AppN=10 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28 |
| Group 2 | Experimental | Device: Cornerstones4Care Powered by Glooko AppN=20 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be diagnosed with type 2 diabetes
- Live in the New York Metropolitan area
- Be at least 18 years of age
- Able to read, write, and speak in English
- Have an iPhone or Android phone
Key exclusion criteria (8 listed)
- Not be diagnosed with type 2 diabetes
- Not living in the New York Metropolitan area
- Be less than 18 years of age
- Be unable to read, write, and speak in English
- Not have an iPhone or Android phone
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 |
|---|---|---|
| Cornerstones4Care Powered by Glooko AppCornerstones4Care Powered by Glooko App is an iOS or Android smartphone application designed to support diabetes management by offering people with diabetes easily accessible, personalized tools for self-monitoring and education. C4C allows people with diabetes to monitor personal health metrics and blood glucose levels, with the aim to achieve participant behavior changes that may contribute to lower hospitalizations, diabetes-related complications and overall healthcare costs. | Device | Group 1, Group 2 |
Primary outcome
Usage of the Cornerstones4Care Powered by Glooko App as assessed by self-report
Time frame: 28 days
Device usability as assessed by the System Usability Scale (SUS)
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- 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.
Stan Kachnowski, PhD, MPP principal investigator
Healthcare Innovation Technology Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cornerstones4Care Powered by Glooko App in people with Diabetes Mellitus, Type 2, run by Healthcare Innovation Technology Lab 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 8 inclusion and 8 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 26 Jul 2017. 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 Claire Gutermuth (9173492528, C4C@hitlab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of the Cornerstones4Care Powered by Glooko App as assessed by self-report (time frame: 28 days). 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 26 Jul 2017.