Evaluating the Impact of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics

September 3, 2019 updated by: Kristin Neland, Welkin Health

Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics

Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced using an mobile application and care management platform.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced by integrating a participant-facing mobile application with the coaching platform. Blood glucose test results automatically populate the coaching platform, providing the CDE with information that may better support their coaching efforts.

The participants complete Diabetes Self Management Education (DSME) learning modules for the first 7-12 weeks. Following completion of the modules, the coach continues to provide support to the participant until 24 weeks after the participant's enrollment.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Welkin Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lives in the United States
  • Speaks and understands English
  • Has a Type 2 diabetes mellitus diagnosis
  • Has a LifeScan Verio Flex blood glucose meter, which is connected to OneTouch Reveal ® app
  • Has a verified A1c ≥ 8%
  • Willing to participate in coaching program

Exclusion Criteria:

  • Uses a continuous glucose monitoring device
  • Currently pregnant
  • Unable to make lifestyle behavioral changes due to a cognitive or physical disability
  • Has end stage renal disease (ESRD) diagnosis
  • Is not able to read or understand English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Live diabetes coaching program
Behavioral: Live diabetes coaching program
Live diabetes coaching program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c
Time Frame: A1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the study
Blood serum test to measure glucose control
A1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Welkin Health

Collaborators

LifeScan

Investigators

  • Principal Investigator: Kristin Neland, BSN, MPH, Welkin Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2018

Primary Completion (Actual)

June 25, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • OTR_COACHING1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators will not share IPD with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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