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Mobile Diabetes Management

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ClinicalTrials.gov Identifier: NCT01107015
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Charlene C. Quinn, University of Maryland

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Device: Tailored Patient Intervention Device: Patient-physician intervention Device: Patient and PCP intervention with analyzed data Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Mobile Diabetes Management
Study Start Date : June 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2011

Arm Intervention/treatment
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
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.

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
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.

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
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.




Primary Outcome Measures :
  1. HBA1c at One Year [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107015


Locations
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Charlene C Quinn, RN, PhD University of Maryland

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charlene C. Quinn, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01107015     History of Changes
Other Study ID Numbers: HP-00041426
First Posted: April 20, 2010    Key Record Dates
Results First Posted: March 1, 2018
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by Charlene C. Quinn, University of Maryland:
Diabetes
Glucose control
Diabetes monitoring
Care management
Electronic communication
Mobile phone technology
Self care

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases