Mobile Diabetes Management

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Patient Intervention

Device

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 intervention

Device

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.

Patient and PCP intervention with analyzed data

Device

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.

Primary outcomes

HBA1c at One Year

Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Apr 20, 2010
Registry last updated: May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed