NCT03363100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
624

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

December 5, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

November 30, 2017

Last Update Submit

July 30, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • A1c

    Change in A1c from study baseline to study end for participants

    Baseline and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Digital health Partnership program

Control

NO INTERVENTION

Interventions

Digital health Partnership programBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Humana Medicare Advantage member
  • Type 2 diabetes diagnosis
  • HbA1c levels ≥ 8.0% verified by lab test

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

December 5, 2017

Primary Completion

February 23, 2019

Study Completion

February 23, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)