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Mobile Diabetes Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107015
First Posted: April 20, 2010
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Charlene C. Quinn, RN, PhD, University of Maryland
April 17, 2010
April 20, 2010
October 26, 2017
June 2008
August 2010   (Final data collection date for primary outcome measure)
Change in HbA1c from baseline to study end. [ Time Frame: baseline, one year ]
Same as current
Complete list of historical versions of study NCT01107015 on ClinicalTrials.gov Archive Site
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Mobile Diabetes Management
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Diabetes
  • 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.
  • Device: 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.
  • Device: 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.
  • No Intervention: Group 1: Usual Care
    Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
  • Active Comparator: Group 2: patient intervention
    Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback
    Intervention: Device: Tailored Patient Intervention
  • Active Comparator: Group 3: patient-physician intervention
    Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook
    Intervention: Device: Patient-physician intervention
  • Active Comparator: Group 4: data analyzed intervention
    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
    Intervention: Device: Patient and PCP intervention with analyzed data
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
September 2011
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01107015
HP-00041426
Yes
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Charlene C. Quinn, RN, PhD, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Charlene C Quinn, RN, PhD University of Maryland
University of Maryland
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP