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Digital Self-Management 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092882
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Humana Co.Ltd.
Information provided by (Responsible Party):
Evidation Health

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Diabetes Self-Management Program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 607 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : February 7, 2018
Actual Study Completion Date : February 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicare

Arms and Interventions
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Arm Intervention/treatment
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.
No Intervention: Control


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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): NCT03092882


Locations
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United States, California
Evidation Health
San Mateo, California, United States, 94401
Sponsors and Collaborators
Evidation Health
Humana Co.Ltd.
Investigators
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Principal Investigator: Jessie Juusola, PhD Evidation Health
More Information
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Responsible Party: Evidation Health
ClinicalTrials.gov Identifier: NCT03092882     History of Changes
Other Study ID Numbers: EH-004
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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