Utilizing Off-the-shelf Technology to Improve Diabetes Management in a Rural Population

January 4, 2018 updated by: Morgan Carlile, University of Missouri-Columbia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypothesis: Intervening in a rural primary care population with a clinically validated telehealth tool (Epharmix Diabetes) that algorithmically triages patients and facilitates patient-provider communication will result in a statistically significant improvement in the indicators of diabetes control.

Study Design

  • Study Type: Experimental, non-controlled crossover study (intervention vs. standard of care for clinic)
  • Primary aim: decrease average self-tested pre-prandial blood glucose level and HgbA1C
  • Secondary aim: decreased number of disease-related emergency room (ER) visits, decreased number of self-reported blood glucose measurements outside of goal
  • Duration: 3 months + 1 month enrollment period
  • Safety: Protocol will be under direction of University of Missouri Institutional Review Board (IRB). All patients will be referred to emergency department if unsafe blood glucose levels are reported. All information is encrypted and HIPAA compliant.
  • Sample Size: Clinic flow analysis estimates 61 patients eligible for study (5 providers, assuming 30% of eligible patients who meet inclusion criteria during 4-week enrollment period interested), with 50 patients likely to stay in study (80% retention rate).
  • Power analysis: Based on pilot data and assuming an alpha error = 0.05, this study will have have greater than 80% statistical power of detecting differences in populations using only 20 patients with a minimum detectable effect size (decrease in HgbA1C) of 0.7%

Methodology

  • The investigator will supply family practice clinics at Mercy with a one-page summary and advertisement of the intervention. At some point during a clinical encounter with a patient with an existing or new diagnosis of diabetes, providers will invite the patient to participate in this Community Integration Project. Providers will maintain a list of patients interested in the study with corresponding phone numbers and the investigator will regularly add patients to the study.
  • Over a 3-month study period, patients will interact with the telehealth system twice a day, entering blood glucose levels when prompted. As recommended by physicians at Mercy, the investigator will message the physicians once a week with a digest of their patients at risk through the existing electronic medical record (EMR) inbox to more easily integrate with existing clinic flow.
  • HgbA1c will be measured prior to starting intervention and will be measured within 7 days of completing intervention.
  • Providers will be notified by the system when patients are triaged to be "high risk," that is, out of a pre-selected range of self-reported blood glucose levels. Providers can then be automatically connected with these patients to titrate blood glucose control.
  • At the conclusion of study, new average self-reported blood glucose responses will be compared against those averages prior to intervention and to clinic averages for patients with diabetes. Additionally, HgbA1C levels will be compared pre and post -intervention.
  • Results will be analyzed and conclusions will be presented to participating stakeholders in a poster session.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 18-70 years of age
  2. Gender: Any gender
  3. Language: patients must use English as primary language
  4. Patient must be ambulatory patients at Mercy Family Practice Clinic in Rolla, Missouri
  5. Patient must have access to touch tone telephone or mobile phone with texting capability
  6. Patient must have documented type 2 diabetes mellitus with a treatment plan that includes measuring pre-prandial blood glucose levels each morning.
  7. HgbA1c between 7 and 9%

Exclusion Criteria:

  • Patients that are identified by clinic staff who have demonstrated noncompliance
  • Lack of access to mobile or landline telephone
  • Hospitalized patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EpxDiabetes software
Subjects will interact daily with a commercially available telemedicine product, Epharmix Diabetes (EpxDiabetes).
Behavioral: EpxDiabetes software
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.
Other Names:
  • Epharmix Diabetes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute change in laboratory-measured HgbA1C
Time Frame: Baseline, 3 months
Patients will undergo two diagnostic blood collections to measure baseline and final HgbA1C.
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Uzma Khan, MD, University of Missouri-Columbia
  • Principal Investigator: Morgan A Carlile, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007269C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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