Mobile Diabetes Management
This study has been completed.
Sponsor:
University of Maryland
Information provided by (Responsible Party):
Charlene C. Quinn, RN, PhD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01107015
First received: April 17, 2010
Last updated: June 17, 2013
Last verified: June 2013
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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:
MedlinePlus related topics:
Choosing a Doctor or Health Care Service
Diabetes
Talking With Your Doctor
Drug Information available for:
Dextrose
U.S. FDA Resources
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)
|
|
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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.
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|
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.
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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: | June 17, 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 June 17, 2013