One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c

December 10, 2019 updated by: Jessie Juusola, Evidation Health
The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2 diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch in combination with the One Drop app and Experts program, and assess whether this group is more engaged or experiences a different impact as compared to participants who utilized the One Drop app and Experts program only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94401
        • Evidation Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Self-reported Type 2 diabetes diagnosis
  • Has not changed treatment regimen in the last 3 months
  • HbA1c levels ≥ 7.5% by self-report and verified by lab test
  • Motivated to use a daily diabetes self-management coaching program to improve diabetes control
  • Owns and uses an iPhone with a compatible iOS operating system and has successfully downloaded and used a smartphone application previously

Exclusion Criteria:

  • Current use of a smartphone application to manage their diabetes
  • Currently participating in a diabetes self-management education or coaching program
  • Currently pregnant
  • Does not understand English
  • History of serious mental illness or dementia
  • Has severe diabetic complications such as severe diabetic retinopathy, chronic kidney disease (stages 4-5), severe diabetic neuropathy, diabetic foot ulcer or infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One Drop Experts Program
Participants will be able to use the One Drop mobile app and One Drop Experts program on their smartphones. The One Drop mobile app is a diabetes management platform that allows users to track and log their blood glucose levels, medications, food, and activities. One Drop Experts is a diabetes education and coaching program delivered entirely through the One Drop mobile application.
Behavioral: One Drop Experts Program
Experimental: One Drop Experts Program + Apple Watch
An Apple Watch will be provided to study participants in this arm. In addition to using the One Drop mobile app and One Drop Experts program on their smartphones, participants will also be able to engage with the app and program on their Apple Watch.
Behavioral: One Drop Experts Program + Apple Watch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

One Drop

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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