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NCT03719911 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03719911
Other study ID # OTR_COACHING1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2018
Est. completion date July 1, 2019

Study information
Verified date September 2019
Source Welkin Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date July 1, 2019
Est. primary completion date June 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Live diabetes coaching program
Live diabetes coaching program

Locations
Country Name City State
United States Welkin Health San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
Welkin Health LifeScan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Hemoglobin A1c Blood serum test to measure glucose control 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
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