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

Sponsor
Welkin Health (Other)
Overall Status
Completed
CT.gov ID
NCT03719911
Collaborator
LifeScan (Industry)
72
Enrollment
1
Location
1
Arm
10.8
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Live diabetes coaching program
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single-arm 24-week pre-post studysingle-arm 24-week pre-post study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
Actual Study Start Date :
Aug 5, 2018
Actual Primary Completion Date :
Jun 25, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Live diabetes coaching program

Live diabetes coaching program

Behavioral: Live diabetes coaching program
Live diabetes coaching program

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Welkin Health San Francisco California United States 94110

Sponsors and Collaborators

  • Welkin Health
  • LifeScan

Investigators

  • Principal Investigator: Kristin Neland, BSN, MPH, Welkin Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristin Neland, Clinical Program Designer, Welkin Health
ClinicalTrials.gov Identifier:
NCT03719911
Other Study ID Numbers:
  • OTR_COACHING1
First Posted:
Oct 25, 2018
Last Update Posted:
Sep 6, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 6, 2019