Recruiting

Observational Study

Sponsor:

Healthcare Innovation Technology Lab

Code:

NCT03222284

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cornerstones4Care Powered by Glooko App

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT03222284

Start date

Jul 17, 2017

Status verified date

Jul, 2017

Completion date

Nov 30, 2017

Anticipated

Primary completion date

Nov 30, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be diagnosed with type 2 diabetes
2. Live in the New York Metropolitan area
3. Be at least 18 years of age
4. Able to read, write, and speak in English
5. Have an iPhone or Android phone
6. Use a blood glucose meter
7. Regularly take insulin by injection
8. Be willing to follow study requirements for a 28-day period

Exclusion Criteria:

1. Not be diagnosed with type 2 diabetes
2. Not living in the New York Metropolitan area
3. Be less than 18 years of age
4. Be unable to read, write, and speak in English
5. Not have an iPhone or Android phone
6. Not use a blood glucose meter
7. Not regularly take insulin by injection
8. Be unwilling to follow study requirements for a 28-day period

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Group 1

N=10 Device intervention

1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28

experimental: Group 2

N=20 Device intervention

1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28

Interventions

Cornerstones4Care Powered by Glooko App

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Claire Gutermuth

9173492528C4C@hitlab.org

Locations

Healthcare Innovation and Technology Lab

Recruiting

New York, New York, United States, 10032

Contacts

Claire Gutermuth

917-349-2528C4C@hitlab.org

More Information

Sponsor

Healthcare Innovation Technology Lab

Last update posted

Jul 26, 2017

Last verified

Jul, 2017

Keywords

  • diabetes
  • type 2 diabetes
  • type ii diabetes
  • insulin
  • mobile applications
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • smartphone application
  • health application

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Healthcare Innovation Technology Lab on 2017-07-26.