Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

One Drop Experts Program

One Drop Experts Program + Apple Watch

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Evidation Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

One Drop Experts Program

One Drop Experts Program + Apple Watch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Full Information

NCT ID

NCT02827669

First Posted

July 5, 2016

Last Updated

December 10, 2019

Sponsor

Evidation Health

Collaborators

One Drop

1. Study Identification

Unique Protocol Identification Number

NCT02827669

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Evidation Health

Collaborators

One Drop

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

297 (Actual)

8. Arms, Groups, and Interventions

Arm Title

One Drop Experts Program

Arm Type

Experimental

Arm Description

Arm Title

One Drop Experts Program + Apple Watch

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

One Drop Experts Program

Intervention Type

Behavioral

Intervention Name(s)

One Drop Experts Program + Apple Watch

Primary Outcome Measure Information:

Title

HbA1c

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Evidation Health

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs