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Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03363100
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The Diabetes Coaching 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 Health Partnership on A1c levels for individuals with uncontrolled Type 2 diabetes.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Behavioral: Digital health Partnership program

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Diabetes Coaching Program for Medicare Advantage Members With Type 2 Diabetes - Impact on A1c
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : September 3, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicare
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention Behavioral: Digital health Partnership program
The program pairs patients with their own certified diabetes educator coach who will guide the patient through a personalized program that leverages a proven educational curriculum combined with proven patient engagement methods.
No Intervention: Control


Outcome Measures

Primary Outcome Measures :
  1. A1c [ Time Frame: Baseline and 6 months ]
    Change in A1c from study baseline to study end for participants


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363100


Contacts
Contact: Jessie L Juusola, PhD 415-878-6508 humanaglucose@myachievement.com

Locations
United States, California
Evidation Health Recruiting
San Mateo, California, United States, 94401
Contact: Jessie L Juusola, PhD         
Contact    415-878-6508    jjjuusola@evidation.com   
Sponsors and Collaborators
Evidation Health
Humana Co.Ltd.
More Information

Responsible Party: Evidation Health
ClinicalTrials.gov Identifier: NCT03363100     History of Changes
Other Study ID Numbers: EH-006
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs