Utilizing Off-the-shelf Technology to Improve Diabetes Management in a Rural Population
1 other identifier
interventional
28
1 country
1
Brief Summary
This study is designed to see if rural patients with type II diabetes interacting with their clinic staff by providing daily updates of blood glucose levels will improve glucose control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Mar 2017
Shorter than P25 for not_applicable diabetes
1 active site
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
March 13, 2017
CompletedFirst Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2017
CompletedJanuary 8, 2018
January 1, 2018
5 months
April 3, 2017
January 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in laboratory-measured HgbA1C
Patients will undergo two diagnostic blood collections to measure baseline and final HgbA1C.
Baseline, 3 months
Study Arms (1)
EpxDiabetes software
EXPERIMENTALSubjects will interact daily with a commercially available telemedicine product, Epharmix Diabetes (EpxDiabetes).
Interventions
Subjects will interact daily with a commercially available telemedicine product, Epharmix Diabetes (EpxDiabetes). They will each undergo a baseline blood draw to establish the control HgbA1C associated with standard of care. Three months later they will undergo an experimental blood draw to establish the HgbA1C associated with the use of EpxDiabetes. Between those procedures, the patient will interact with the intervention daily.
Eligibility Criteria
You may qualify if:
- Age: 18-70 years of age
- Gender: Any gender
- Language: patients must use English as primary language
- Patient must be ambulatory patients at Mercy Family Practice Clinic in Rolla, Missouri
- Patient must have access to touch tone telephone or mobile phone with texting capability
- Patient must have documented type 2 diabetes mellitus with a treatment plan that includes measuring pre-prandial blood glucose levels each morning.
- HgbA1c between 7 and 9%
You may not qualify if:
- Patients that are identified by clinic staff who have demonstrated noncompliance
- Lack of access to mobile or landline telephone
- Hospitalized patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Morgan A Carlile
University of Missouri-Columbia
- PRINCIPAL INVESTIGATOR
Uzma Khan, MD
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Student
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 7, 2017
Study Start
March 13, 2017
Primary Completion
July 31, 2017
Study Completion
December 5, 2017
Last Updated
January 8, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share