Mobile Diabetes Management

Study Overview
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Brief Summary
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The Mobile Diabetes Intervention Study trial is evaluating a diabetes coaching system, using mobile phones and patient/ physician internet portals to allow patient-specific treatment and communication by their primary care physician. We hypothesize that timely information provided to patients and their physicians can result in reduction of A1c over 1 year.

Official Title
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Mobile Diabetes Management

Conditions
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Diabetes

Intervention / Treatment
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* Device: Tailored Patient Intervention
* Device: Patient-physician intervention
* Device: Patient and PCP intervention with analyzed data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic [patient] A1c equal to or greater than 7.5 [patient] 18-64 years of age at time of recruitment [patient] Access to the internet (does not need to be at their home, elsewhere is fine e.g. work) [patient] E-mail account [patient] Must speak English [patient] Exclusion Criteria: No insulin pump [patient] No current alcohol or drug abuse- must be sober 1 year [patient] Not currently pregnant [patient] No terminal diagnosis [patient] No dementia or Alzheimer's [patient] No active chemotherapy [patient] No significant hearing impairment [patient] Poorly corrected vision that would impede use of phone [patient] No mute or aphasia [patient] No diagnosis of schizophrenia, bipolar disorder, or major psychosis [patient] No Medicaid or Medicare No uninsured

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1: Usual Care<br>Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) | |
| Active Comparator: Group 2: patient intervention<br>Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback | Device: Tailored Patient Intervention<br>* Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months.<br>|
| Active Comparator: Group 3: patient-physician intervention<br>Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook | Device: Patient-physician intervention<br>* Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not been analyzed.<br>|
| Active Comparator: Group 4: data analyzed intervention<br>Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations | Device: Patient and PCP intervention with analyzed data<br>* Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electronic logbooks. PCPs are provided with data analysis reports. The PCP is reminded that all data analysis is based on patient-entered, unvalidated data. The PCP has the option to use this information and remains responsible for all treatment decisions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBA1c at One Year |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Glucose control, Diabetes monitoring, Care management, Electronic communication, Mobile phone technology, Self care