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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Live diabetes coaching program

• Registration Number: NCT03719911
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-08-05
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Primary Completion: 2019-06-25
• Study Completion: 2019-07-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Live diabetes coaching program	Live diabetes coaching program	Live diabetes coaching program

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	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

Trial Locations

Locations (1)

Welkin Health; 🇺🇸 San Francisco, California, United States