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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02827669
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
One Drop
Information provided by (Responsible Party):
Jessie Juusola, Evidation Health

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: One Drop Experts Program Behavioral: One Drop Experts Program + Apple Watch Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
Actual Study Start Date : June 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827669


Locations
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United States, California
Evidation Health
San Mateo, California, United States, 94401
Sponsors and Collaborators
Evidation Health
One Drop
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jessie Juusola, Sr. Director, Health Outcomes Research, Evidation Health
ClinicalTrials.gov Identifier: NCT02827669    
Other Study ID Numbers: EH-001
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases