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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03363100
Other study ID # EH-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2017
Est. completion date February 23, 2019

Study information

Verified date July 2019
Source Evidation Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 624
Est. completion date February 23, 2019
Est. primary completion date February 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Evidation Health San Mateo California

Sponsors (2)

Lead Sponsor Collaborator
Evidation Health Humana Co.Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary A1c Change in A1c from study baseline to study end for participants Baseline and 6 months
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