ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03719911
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
LifeScan
Information provided by (Responsible Party):
Kristin Neland, Welkin Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Live diabetes coaching program Not Applicable

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 the 24 weeks after the participant's enrollment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single-arm 24-week pre-post study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
Actual Study Start Date : August 5, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

Arm Intervention/treatment
Experimental: Live diabetes coaching program
Live diabetes coaching program
Behavioral: Live diabetes coaching program
Live diabetes coaching program




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719911


Locations
United States, California
Welkin Health Recruiting
San Francisco, California, United States, 94110
Contact: Kristin Neland, BSN, MPH    512-694-7104    kristin@welkinhealth.com   
Contact: Gideon Wald    5126947104    gideon@welkinhealth.com   
Principal Investigator: Kristin Neland, BSN, MPH         
Sub-Investigator: Larry Katz, PhD         
Sponsors and Collaborators
Welkin Health
LifeScan
Investigators
Principal Investigator: Kristin Neland, BSN, MPH Welkin Health

Responsible Party: Kristin Neland, Clinical Program Designer, Welkin Health
ClinicalTrials.gov Identifier: NCT03719911     History of Changes
Other Study ID Numbers: OTR_COACHING1
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Investigators will not share IPD with other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases