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Clinical Trials/NCT03719911
NCT03719911
Completed
Not Applicable

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

Welkin Health1 site in 1 country72 target enrollmentAugust 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Welkin Health
Enrollment
72
Locations
1
Primary Endpoint
Change in Hemoglobin A1c
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2018
End Date
July 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Welkin Health
Responsible Party
Principal Investigator
Principal Investigator

Kristin Neland

Clinical Program Designer

Welkin Health

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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