Mobile Diabetes Management

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01107015

HP-00041426

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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213 participants in 4 patient groups

Group 1: Usual Care

No Intervention group

Description:

Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)

Group 2: patient intervention

Active Comparator group

Description:

Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback

Treatment:

Device: Tailored Patient Intervention

Group 3: patient-physician intervention

Active Comparator group

Description:

Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook

Treatment:

Device: Patient-physician intervention

Group 4: data analyzed intervention

Active Comparator group

Description:

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

Treatment:

Device: Patient and PCP intervention with analyzed data