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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719911
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
LifeScan
Information provided by (Responsible Party):
Kristin Neland, Welkin Health

Study Description
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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 24 weeks after the participant's enrollment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
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
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

Arms and Interventions
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Arm Intervention/treatment
Experimental: Live diabetes coaching program
Live diabetes coaching program
 Behavioral: Live diabetes coaching program
Live diabetes coaching program


Outcome Measures
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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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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
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United States, California
Welkin Health
San Francisco, California, United States, 94110
Sponsors and Collaborators
Welkin Health
LifeScan
Investigators
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Principal Investigator: Kristin Neland, BSN, MPH Welkin Health
More Information
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Responsible Party: Kristin Neland, Clinical Program Designer, Welkin Health
ClinicalTrials.gov Identifier: NCT03719911    
Other Study ID Numbers: OTR_COACHING1
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Investigators will not share IPD with other researchers

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