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

Overview

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.

Full Title of Study: “Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 25, 2019

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.

Interventions

  • Behavioral: Live diabetes coaching program
    • Live diabetes coaching program

Arms, Groups and Cohorts

  • Experimental: Live diabetes coaching program
    • Live diabetes coaching program

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Welkin Health
  • Collaborator
    • LifeScan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kristin Neland, Clinical Program Designer – Welkin Health
  • Overall Official(s)
    • Kristin Neland, BSN, MPH, Principal Investigator, Welkin Health

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