NCT03719911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

September 25, 2018

Last Update Submit

September 3, 2019

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Live diabetes coaching program

EXPERIMENTAL

Live diabetes coaching program

Behavioral: Live diabetes coaching program

Interventions

Live diabetes coaching programBEHAVIORAL

Live diabetes coaching program

Live diabetes coaching program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Welkin Health

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kristin Neland, BSN, MPH

    Welkin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-arm 24-week pre-post study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Program Designer

Study Record Dates

First Submitted

September 25, 2018

First Posted

October 25, 2018

Study Start

August 5, 2018

Primary Completion

June 25, 2019

Study Completion

July 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Investigators will not share IPD with other researchers

Locations

US(1)