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

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

Sponsors

Lead Sponsor: Welkin Health

Collaborator: LifeScan

Source 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.

Overall Status Completed
Start Date August 5, 2018
Completion Date July 1, 2019
Primary Completion Date June 25, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 72
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Live diabetes coaching program

Description: Live diabetes coaching program

Arm Group Label: Live diabetes coaching program

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kristin Neland, BSN, MPH Principal Investigator Welkin Health
Location
Facility: Welkin Health
Location Countries

United States

Verification Date

September 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Welkin Health

Investigator Full Name: Kristin Neland

Investigator Title: Clinical Program Designer

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Live diabetes coaching program

Type: Experimental

Description: Live diabetes coaching program

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: single-arm 24-week pre-post study

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov