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

NCT ID: NCT02827669

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

One Drop Experts Program

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

One Drop Experts Program + Apple Watch

Intervention Type BEHAVIORAL

Interventions

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One Drop Experts Program

Intervention Type BEHAVIORAL

One Drop Experts Program + Apple Watch

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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One Drop

UNKNOWN

Sponsor Role collaborator

Evidation Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Jessie Juusola

Sr. Director, Health Outcomes Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Evidation Health

San Mateo, California, United States

Site Status

Countries

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United States

Other Identifiers

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EH-001

Identifier Type: -

Identifier Source: org_study_id