NCT02827669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

July 5, 2016

Last Update Submit

December 10, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    3 months

Study Arms (2)

One Drop Experts Program

EXPERIMENTAL

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

One Drop Experts Program + Apple Watch

EXPERIMENTAL

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

Interventions

One Drop Experts ProgramBEHAVIORAL
One Drop Experts Program
One Drop Experts Program + Apple WatchBEHAVIORAL
One Drop Experts Program + Apple Watch

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sr. Director, Health Outcomes Research

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

US(1)