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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02827669
• Lead Sponsor: Evidation Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	3 months

Trial Locations

Locations (1)

Evidation Health; 🇺🇸 San Mateo, California, United States