Back to resultsDigital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Self-Management Program
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- Evidation Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Diabetes Self-Management Program
Outcomes
Primary Outcome Measures
Change from Baseline in A1c at 6 months
Change in A1c from study baseline to study end
Secondary Outcome Measures
Full Information
NCT ID
NCT03092882
First Posted
March 22, 2017
Last Updated
June 23, 2019
Sponsor
Evidation Health
Collaborators
Humana Co.Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03092882
Brief Title
Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
Official Title
Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evidation Health
Collaborators
Humana Co.Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
607 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Diabetes Self-Management Program
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Self-Management Program
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in A1c at 6 months
Description
Change in A1c from study baseline to study end
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie Juusola, PhD
Organizational Affiliation
Evidation Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evidation Health
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
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