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OpenTrials
Completed

NCT Number: NCT03719911

Evaluating the Impact 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Welkin Health

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Live diabetes coaching program

Behavioral

Live diabetes coaching program

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Welkin Health

Other

Collaborators

  • LifeScan

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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