Mobile Diabetes Management

Diabetes Clinical Trial

Official title:

Mobile Diabetes Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107015
• Other study ID #: HP-00041426
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: September 2011

Study information

• Verified date: December 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Device:
• Tailored Patient Intervention
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
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
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.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (1)

Quinn CC, Gruber-Baldini AL, Shardell M, Weed K, Clough SS, Peeples M, Terrin M, Bronich-Hall L, Barr E, Lender D. Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control. Contemp Clin Trials. 2009 Jul;30(4):334-46. doi: 10.1016/j.cct.2009.02.004. Epub 2009 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBA1c at One Year		one year

External Links

•   Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control.Diabetes Care. 2011 Sep;34(9):1934-42. Epub 2011 Jul 25.