Mobile Diabetes Management

University of Maryland, Baltimore213 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

213

Conditions

Diabetes

Interventions

Tailored Patient InterventionDEVICE

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.

Patient-physician interventionDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland, Baltimore

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

HBA1c at One Year

Time frame: one year

Data from ClinicalTrials.gov

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Patient and PCP intervention with analyzed dataDEVICE

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.