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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evidation Health

San Mateo, California, 94401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Self-Management Program

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.

Primary outcomes

Change from Baseline in A1c at 6 months

Time frame: Baseline and 6 months

Change in A1c from study baseline to study end

Sponsors and collaborators

Lead sponsor

Evidation Health

Industry

Collaborators

Humana Co.Ltd.

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Mar 28, 2017
Registry last updated: Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed