Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c

NCT ID: NCT03092882

Last Updated: 2019-06-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

607 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2018-02-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Digital Self-Management Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Self-Management Program on A1c levels for individuals with uncontrolled Type 2 diabetes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Diabetes Self-Management Program

Group Type EXPERIMENTAL

Diabetes Self-Management Program

Intervention Type BEHAVIORAL

The Diabetes Self-Management Program is a platform that includes a smart meter, access to coaching 24/7, and a mobile app and website that help members manage their diabetes. The program offers diabetes education and coaching delivered entirely through the smart meter and mobile app or website.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diabetes Self-Management Program

The Diabetes Self-Management Program is a platform that includes a smart meter, access to coaching 24/7, and a mobile app and website that help members manage their diabetes. The program offers diabetes education and coaching delivered entirely through the smart meter and mobile app or website.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Humana Medicare Advantage member
* Type 2 diabetes diagnosis
* HbA1c levels ≥ 8.0% verified by lab test

Exclusion Criteria

* Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease
* Not fluent in English
* Humana membership is part of a Full or Global risk arrangement
* Enrolled in Humana at Home Care Management
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Humana Co.Ltd.

INDUSTRY

Sponsor Role collaborator

Evidation Health

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jessie Juusola, PhD

Role: PRINCIPAL_INVESTIGATOR

Evidation Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Evidation Health

San Mateo, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EH-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Michigan Men's Diabetes Project 2
NCT05370781 ACTIVE_NOT_RECRUITING NA