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

June 23, 2019 updated by: Evidation Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

607

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94401
        • Evidation Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Intervention
Diabetes Self-Management Program
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in A1c at 6 months
Time Frame: Baseline and 6 months
Change in A1c from study baseline to study end
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

Humana Co.Ltd.

Investigators

  • Principal Investigator: Jessie Juusola, PhD, Evidation Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2017

Primary Completion (Actual)

February 7, 2018

Study Completion (Actual)

February 7, 2018

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 27, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 23, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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