Mobile Diabetes Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charlene C. Quinn, RN, PhD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01107015
First received: April 17, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention
Diabetes
Device: Tailored Patient Intervention
Device: Patient-physician intervention
Device: Patient and PCP intervention with analyzed data

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Mobile Diabetes Management

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Change in HbA1c from baseline to study end. [ Time Frame: baseline, one year ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: June 2008
Study Completion Date: September 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, Baltimore County
  More Information

Additional Information:
Publications:
Responsible Party: Charlene C. Quinn, RN, PhD, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01107015     History of Changes
Other Study ID Numbers: HP-00041426
Study First Received: April 17, 2010
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on April 16, 2014