Evaluating the Impact of a Technologically-Enhanced Perso... | NCT03719911

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

NCT03719911

Sponsor

Welkin Health

Status

Completed

Last Update Posted

Sep 6, 2019Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Live diabetes coaching program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2018Actual

Primary Completion Date

Jun 25, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Oct 23, 2018

First Posted Date

Oct 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2019

Last Update Posted Date

Sep 6, 2019Actual

Name	Class
LifeScan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Live diabetes coaching program	Experimental	Live diabetes coaching program	Behavioral: Live diabetes coaching program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Live diabetes coaching program	Behavioral	Live diabetes coaching program	Live diabetes coaching program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristin Neland, BSN, MPH	Welkin Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Welkin Health		San Francisco	California	94110	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Investigators will not share IPD with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided