NCT03092882

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
607

participants targeted

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

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

Study Start

First participant enrolled

March 3, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2018

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

March 22, 2017

Last Update Submit

June 23, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in A1c at 6 months

    Change in A1c from study baseline to study end

    Baseline and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Diabetes Self-Management Program

Behavioral: Diabetes Self-Management Program

Control

NO INTERVENTION

Interventions

Diabetes Self-Management ProgramBEHAVIORAL

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.

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 Officials

  • Jessie Juusola, PhD

    Evidation Health

    PRINCIPAL INVESTIGATOR

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

March 22, 2017

First Posted

March 28, 2017

Study Start

March 3, 2017

Primary Completion

February 7, 2018

Study Completion

February 7, 2018

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)