Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
Evaluating the Impact of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
Sponsors
Source
Welkin Health
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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
2018-08-05
Completion Date
2019-07-01
Primary Completion Date
2019-06-25
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
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 San Francisco California 94110 United States |
Location Countries
Country
United States
Verification Date
2019-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
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
Arm Group Label
Live diabetes coaching program
Arm Group Type
Experimental
Description
Live diabetes coaching program
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Ipd Description
Investigators will not share IPD with other researchers
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Intervention Model Description
single-arm 24-week pre-post study
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
September 25, 2018
Study First Submitted Qc
October 23, 2018
Study First Posted
October 25, 2018
Last Update Submitted
September 3, 2019
Last Update Submitted Qc
September 3, 2019
Last Update Posted
September 6, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.