Utilizing Off-the-shelf Technology to Improve Diabetes Management in a Rural Population
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

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.
    

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.
    

Intervention name(s): EpxDiabetes software
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Epharmix Diabetes
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 2 diabetes